7 Colo. Code Regs. § 1101-3-17-01-8
Introduction. Spinal injections are considered when function remains limited despite appropriate non-operative treatment options. Diagnostic spinal injections are used to localize a source of pain when the results would impact the course of treatment. Therapeutic injections are used to temporarily reduce functional impairment. Most individuals with low back pain will not need a spinal injection. See the Overview of Care section.
Contraindications / Complications / Side Effects and Adverse Events.
* See the specific injection section.
Core Requirements.
Recommendation 79. Spinal injections are indicated when all of the following criteria are met:
* positive correlation among clinical findings, the clinical course, and diagnostic tests;
* positive functional response to a diagnostic injection, if required;
* persistent functional impairment despite engagement in 6 weeks of active therapy; and confounding psychosocial risk factors have been screened for and clinically addressed. See the Behavioral and Psychological Interventions section.
Recommendation 80. All spinal injections should be preceded by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
Recommendation 81. Informed consent is required before all invasive procedures. See the Essential First Line Treatment section.
Recommendation 82. Routine use of sedation is not recommended for diagnostic or therapeutic spinal injections. Minimal to moderate sedation and pain relief may be needed for some patients but are only permitted when there is documentation of extreme circumstances.
Recommendation 83. All injections must be accompanied by self-directed exercise or formal physical therapy.
Recommendation 84. Multi-planar fluoroscopic imaging is required to create permanent images that confirm proper needle placement and contrast flow pattern. CT needle guidance may be required in rare circumstances.
Recommendation 85. Total steroid injections at all sites, including the extremities, should be limited to 4 per year to avoid side effects from steroids. Prior authorization is required for additional injections with appropriate documentation of medical reasoning and functional improvement.
Recommendation 86. Due to the absence of quality evidence supporting their use, the injection of substances other than steroids, anesthetic, or contrast solution is not recommended (e.g., orthobiologics such as platelet rich plasma, stem cells, or amniotic fluid; ozone; etc.).
Evidence Tables. None. The above recommendations were based on consensus.
Introduction. Epidural steroid injections (ESIs) are corticosteroid injections into the lumbar epidural space by a caudal, transforaminal, or interlaminar approach. A transforaminal nerve root block involves injecting steroid medication near where the nerve root exits the spinal column. The therapeutic goals of injections are to restore range of motion (ROM) and facilitate progress in active therapy programs by temporarily reducing pain and inflammation in the acute or subacute phases of injury. ESIs may result in small, short-lived reduction in leg pain and disability for individuals with lumbar radiculopathy. ESIs do not result in clinically meaningful long-term improvements in leg pain, back pain, or disability in patients with lumbar radicular pain. ESIs do not have a role in the treatment of non-radicular low back pain.
Contraindications / Complications / Side Effects and Adverse Events.
Absolute and Relative Contraindications to ESI.
* Poorly controlled diabetes mellitus, systemic or localized bacterial infection, known anatomic abnormalities, and bleeding diathesis are absolute contraindications to ESI.
* Patients with existing osteoporosis or other risk factors for osteoporosis should rarely receive ESIs.
* Patients on medications that affect coagulation require special consideration prior to ESI.
* Allergy to contrast material, somatization disorder, poorly controlled congestive heart failure, and uncontrolled hypertension are relative contraindications to ESI.
Complications of ESI.
* Long-term morbidity can occur as a result of ESI, although complications that lead to long-term morbidity are rare.
* Permanent paresis, anaphylaxis, and arachnoiditis have been rarely reported with the use of epidural steroids.
* Direct needle trauma is a reported complication (recommendation 89).
* Although major neurological complications are rare with fluoroscopically-guided lumbar ESIs, there is a much greater risk with particulate steroid injections (recommendation 90; table 35).
* Osteoporotic fractures, Cushing's syndrome, hypopituitarism, spinal epidural lipomatosis, and growth hormone deficiency have been associated with ESI.
Side Effects and Adverse Events Related to Injectate.
* Increased blood glucose levels, decreased plasma cortisol levels, and impaired bowel or bladder function are possible side effects of ESI.
* There is a dose-dependent suppression of the hypothalamic-pituitary-adrenal axis, leading to a transient secondary adrenal insufficiency in the first few weeks after ESI (table 34).
Recommendations.
Core Requirements.
Recommendation 87. For a patient to be a candidate for an ESI, the provider must document all of the following:
* subjective report of severe radicular pain that correlates with objective findings;
* positive straight leg raise test, femoral stretch test, and/or reflex, motor, or sensory changes on examination that specifically correlate with imaging findings; and
* imaging findings that demonstrate impingement of nerve(s) or spinal cord.
Recommendation 88. ESI is not recommended for the treatment of axial low back pain in the absence of radicular symptoms (table 39).
Recommendation 89. Multi-planar fluoroscopic imaging is required to create permanent images confirming proper needle placement and contrast flow pattern.
Recommendation 90. Particulate corticosteroid preparations are not recommended for epidural injection (table 35).
Recommendation 91. A patient who meets the ESI indications can trial an epidural injection of local anesthetic alone as an alternative to an injection containing steroid (table 36).
Recommendation 92. All patients with diabetes must be instructed to monitor their glucose levels carefully over the 7 days after steroid injection. Clinicians can pursue diabetic screening tests for those who may be at risk for Type 2 diabetes (table 37).
Recommendation 93. A diagnostic response to a selective nerve root block must be documented to show its value, including:
* improvement in at least 3 objective functional measures (e.g., spinal ROM; straight leg raise; tolerance and time limits for sitting, standing, walking, and lifting); and
* at least 80% improvement in an accepted pain scale (e.g., visual analog scale [VAS] or numeric rating scale [NRS]) that is consistent with:
* the expected duration of the injected local anesthetic phase, and
* a pain diary recording an hourly response for at least 8 hours, but preferably for 1 week,
post-injection. Documentation of pain response may be indicated for up to 3 weeks,
depending on the nature of the injection.
A successful response to a diagnostic injection requires documentation of positive functional changes by trained personnel and may include nurses, physician assistants, medical assistants, therapists, or non-injectionist physicians. Functional progress supersedes pain improvement.
Acute Phase Requirements (Within 6 Weeks of Initial Care).
Recommendation 94. Early referral within 6 weeks for ESI is permitted when the provider documents all criteria in recommendation 87 and at least 1 of the following:
* radicular functional impairment prevents participation in active therapy and activities of daily living (ADLs), or
* an opioid treatment is being considered (table 40).
Recommendation 95. A patient who meets the ESI indications in recommendation 87, but wants to avoid ESI, may trial oral gabapentin (table 38).
Subacute and Chronic Phase Requirements (After 6 Weeks of Care).
Recommendation 96. ESI or referral for surgical consultation are permitted for patients who meet the criteria in recommendation 87 and both of the following:
* functional impairment despite 6 weeks of optimal medical management and participation in active therapy, and
* confounding psychosocial risk factors have been screened for and are being clinically addressed. See the Behavioral and Psychological Interventions section (table 41).
Repeat ESI Requirements.
Recommendation 97. Repeat ESI can occur as soon as 2 weeks after the first injection when the initial injection resulted in a sustained therapeutic response for 2 weeks or more and is characterized by the following:
* improvement in at least 3 objective functional measures (e.g., spinal ROM; tolerance and time limits for sitting, standing, walking, and lifting), and
* 80% radicular pain improvement as measured using an accepted pain scale (e.g., VAS or NRS).
Functional progress supersedes pain improvement. The third injection can then be repeated after a hiatus of 6 months (Appendix Functional Screens). See the Chronic Pain Disorder Medical Treatment Guidelines (MTGs) for information on subsequent injections.
Recommendation 98. Ordering a "series" of ESIs is prohibited. If the first injection fails to result in functional gain and pain relief as outlined in recommendation 97, the injection cannot be repeated at that level with the same approach.
Recommendation 99. If the decision is made to proceed with a different type of injection, the specific criteria for that injection must be satisfied.
Recommendation 100. Testing morning cortisol levels is recommended prior to the third or fourth steroid injection.
Evidence Tables.
Table 34. Evidence Table: ESI and the Hypothalamic-Pituitary-Adrenal Axis | ||
Some evidence | Evidence statement | Design |
In the setting of ESI given for low back pain with radiculopathy, there is a dose-dependent suppression of the hypothalamic-pituitary-adrenal axis leading to a transient secondary adrenal insufficiency in the first few weeks after the procedure, with an 80 mg dose of methylprednisolone acetate leading to secondary adrenal insufficiency in about 80% of patients the first week after the injection, and in about 50% of patients receiving a 40 mg dose. The cortisol response to an injection of adrenocorticotropic hormone (ACTH) gradually returns to normal in the weeks after the injection, but secondary adrenal insufficiency remains detectable in some patients 4 weeks later. | RCT | |
Table 35. Evidence Table: Risk of Particulate ESI | ||
Summary: ESIs with particulate steroids, such as methylprednisolone and triamcinolone, have systemic absorption effects and a much higher risk of major neurological complications than ESIs of water soluble steroids, such as betamethasone and dexamethasone. | ||
Strong evidence | Evidence statement | Design |
Although major neurological complications are rare with fluoroscopically-guided cervical and lumbar ESIs, the risk is much greater with particulate steroid injections. | Systematic review | |
Some evidence | Evidence statement | Design |
Some steroid preparations have a systemic absorption effect, which is reflected in suppression of morning cortisol measurements 3 and 6 weeks after the injection. This appears to be the case with the particulate steroids, methylprednisolone and triamcinolone, but not with the water soluble steroids, betamethasone and dexamethasone. | RCT | |
Table 36. Evidence table: Use of Steroid in Epidural Injections | ||
Summary: For patients with lumbar radicular pain, the addition of a corticosteroid does not provide added improvement in function or pain over epidural injections with local anesthetic alone. While the evidence does not support a benefit of adding steroids to local anesthetic spinal injections, steroids are routinely used in therapeutic spinal injections due to a presumed physiologic effect. | ||
Strong evidence | Evidence statement | Design |
In the setting of low back radicular pain, there are no significant clinical differences between injections of local anesthetic alone and injections of local anesthetic plus steroid. | Systematic review | |
Good evidence | Evidence statement | Design |
Among patients who achieve clinically important benefit from an epidural injection at 6 weeks, the benefits continue for 12 months after the injection. | RCT | |
The addition of steroids to a transforaminal bupivacaine injection has a small, clinically unimportant, and statistically insignificant effect on outcomes of pain and disability in patients with lumbar radicular pain resulting from disc herniation or spinal stenosis. | RCT | |
Particulate steroids offer no advantage over nonparticulate steroids in the setting of transforaminal or interlaminar ESIs for patients with lumbar or cervical radiculopathy, either with respect to pain relief or improvement of function. | Systematic review | |
Some evidence | Evidence statement | Design |
Epidural injections of solutions not containing steroids (such as normal saline or local anesthetic in saline) are likely to have therapeutic effects in the setting of radicular pain, possibly arising from lavage effects and other effects not depending on the steroid component of the injected solution. The interpretation of clinical trials in which epidural steroid and non-steroid injections appear to have similar effects should be influenced by this principle. | Systematic review | |
In the setting of lumbar radiculopathy lasting 12 weeks or longer, there is no clinically important difference between a sham subcutaneous injection of 2 ml of normal saline and a 30 ml caudal injection of saline with or without triamcinolone. | RCT | |
Bupivacaine alone is equal to bupivacaine plus steroid, with no effect of steroid on Oswestry Disability Index (ODI), leg pain, or back pain. | RCT | |
Table 37. Evidence Table: Corticosteroid-Containing ESI in Diabetic Patients | ||
Good evidence | Evidence statement | Design |
In the setting of ESI for patients with adequately controlled diabetes mellitus, significant increases in fasting and postprandial blood glucose can be expected on the day of the procedure and for the first 3 days thereafter; however, the increase in blood glucose are less with a 20 mg than with a 40 mg dose of triamcinolone. There is no difference in pain relief between the 2 steroid doses, making the 20 mg dose preferable to a 40 mg dose. | RCT | |
Table 38. Evidence Table: Early Oral Gabapentin for Radicular Pain | ||
Good evidence | Evidence statement | Design |
In the setting of lumbosacral radiculopathy from herniated disc or spinal stenosis, oral gabapentin without physical therapy and an ESI without physical therapy are approximately equally effective in the first 3 months, but no conclusions can be supported that either intervention is superior to placebo. | RCT | |
Table 39. Evidence Table: ESI for Axial Low Back Pain | ||
Summary: ESIs are not beneficial in the treatment of axial low back pain. | ||
Strong evidence | Evidence statement | Design |
ESIs have no short-term or long-term benefit for low back pain. | Systematic review | |
Lack of evidence | Lack of evidence statement | Design |
A high quality meta-analysis did not provide evidence for any injection therapy (epidural, facet, or local) for non-radicular low back pain. | Meta analysis | |
Table 40. Evidence Table: ESI for Radicular Pain | ||
Summary: ESIs result in a small reduction in leg pain and disability for patients with lumbar radiculopathy, but the benefits are short-lived. ESIs do not result in clinically meaningful long-term improvements in leg pain, back pain, or disability in patients with lumbar radicular pain or radiculopathy. ESI for radicular low back pain may reduce the frequency of surgery in the first year after use. | ||
Strong evidence | Evidence statement | Design |
ESIs have a small average short-term benefit for leg pain and disability for those with sciatica. | Systematic review | |
ESIs do not, on average, provide clinically meaningful long-term improvements in leg pain, back pain, or disability in patients with undefined sciatica (lumbar radicular pain or radiculopathy). | Systematic review | |
Some evidence | Evidence statement | Design |
After 6 weeks of conservative therapy for large herniated discs, an epidural injection may be attempted, as it does not compromise the results of a discectomy at a later date. One half of the patients in this study who were randomized to ESIs did not have surgery and this benefit persisted. Because this study did not have a control group that received neither treatment nor a group that received injections without steroids, one cannot make definite conclusions regarding the efficacy of ESI injections in this setting. | RCT | |
The addition of steroids to a transforaminal bupivacaine injection may reduce the frequency of surgery in the first year after treatment in patients with neurologic compression and corresponding imaging findings who also are strong candidates for surgery and have completed 6 weeks of therapy without adequate benefit. The benefits for the non-surgical group persisted for at least 5 years in most patients, regardless of the type of block given. | RCT | |
Some evidence cont. | The addition of steroids to a transforaminal bupivacaine injection may reduce the frequency of surgery in the first year after treatment. | RCT |
In the setting of lumbar transforaminal ESIs, the volume of injectate plays a role in the analgesic response; an injection of 8 ml of solution with 4 mg of dexamethasone provides greater pain relief than a 3 ml injection with 4 mg of dexamethasone. However, there was no group which received an injection without a steroid component, and no inference can be made about a "pure" lavage effect of a transforaminal injection. | RCT | |
Table 41. Evidence Table: Referral for Surgical Consultation | ||
Summary: In patients with disc herniation who are persistently symptomatic at 6 weeks, ESI may prevent the need for future surgery. The delay in surgery does not appear to reduce later surgical success. | ||
Good evidence | Evidence statement | Design |
Among patients with herniated discs who have remained symptomatic after 6 weeks of noninvasive care and who are likely candidates for surgery, surgical discectomy successfully leads to symptom resolution in a large majority of patients. However, patients from the same population who receive ESI after 6 weeks of unsuccessful noninvasive care frequently experience symptom resolution sufficiently well to be able to avoid surgery. The magnitude of the surgery-sparing effect of ESI has not been established, but as many as half of patients may avoid surgery for up to 3 years. Patients who have an unsuccessful ESI after 6 weeks of noninvasive care may undergo discectomy at a later time, with no evidence that the delay in surgery reduces the success of the later operation. | Systematic review | |
Table 42. Evidence Table: ESI for Spinal Stenosis | ||
Summary: For patients with symptomatic lumbar spinal stenosis, the addition of a corticosteroid does not provide added benefit over epidural injections with local anesthetic alone. For patients with lumbar spinal stenosis and neurogenic claudication accompanied by confirmed hypertrophy of the ligamentum flavum, a minimally invasive percutaneous partial resection of the ligamentum flavum leads to greater functional improvement and reduced pain compared with ESI. | ||
Good evidence | Evidence statement | Design |
In patients with neurogenic claudication arising from lumbar central spinal stenosis, there is little difference in pain and functional benefit at 6 weeks and 12 months between an injection of a local anesthetic and an injection of a local anesthetic plus a corticosteroid. | RCT | |
There are no significant differences between epidural injections with corticosteroid plus local anesthetic versus local anesthetic alone in patients with symptomatic spinal stenosis. | RCT | |
Compared to a fluoroscopically guided interlaminar ESI, a minimally invasive percutaneous partial resection of the ligamentum flavum leads to greater functional improvement and reduced pain at 6 and 12 months in patients with lumbar spinal stenosis and neurogenic claudication accompanied by confirmed hypertrophy of the ligamentum flavum. There is good evidence that these improvements remain stable 24 months following the procedure. However, there is no evidence that the surgical procedure reduces medication use compared to the ESI. | RCT | |
Some evidence | Evidence statement | Design |
Translaminar steroid injections do not increase walking tolerance in those with spinal stenosis compared to local anesthetic. | RCT | |
Lack of evidence | Lack of evidence statement | Design |
There is a lack of evidence of a surgery-sparing effect in symptomatic lumbar spinal stenosis. | Systematic review | |
Table 43. Evidence Table: Repeat ESI in Central Spinal Stenosis | ||
Some evidence | Evidence statement | Design |
Among patients who repeat an ESI after having received 1 injection, there is very little additional benefit to be achieved from the second or subsequent injections. | RCT | |
Introduction. Facet joint injection consists of the intra-articular or pericapsular injection of local anesthetic and corticosteroid. It has very limited uses.
Contraindications / Complications / Side Effects and Adverse Events.
Absolute and Relative Contraindications to Facet Joint Injection.
* Systemic or localized bacterial infection and bleeding diathesis are absolute contraindications to steroid injections. Poorly controlled diabetes is a contraindication if steroids are used.
* Patients with existing osteoporosis or other risk factors for osteoporosis should rarely receive steroid injections. It is unknown if facet joint injections contribute to increased risk of vertebral fractures, but appropriate precautions should be taken for at-risk patients.
* Patients on medications that affect coagulation require special consideration prior to these injections.
* Somatization disorder, poorly controlled congestive heart failure, and uncontrolled hypertension are relative contraindications to these injections. Allergy to contrast material may be a contraindication if alternative contrast material is unavailable.
Complications of Facet Joint Injection.
* Complications include nerve injury, bleeding, infection, contrast allergy, localized pain, or irritation.
* Extravasation of local anesthetic to the lumbar nerves may result in difficulty in ambulation.
* Extravasation to the sacral nerves may result in bowel and bladder impairment.
Side Effects and Adverse Events Related to Facet Joint Injection.
* Diabetic patients may notice a steroid-induced effect on blood glucose levels in the post-injection period.
Recommendations.
Core Requirements.
Recommendation 101. Facet joint injections are of very limited use. One of the following sets of requirements must be met prior to proceeding with a facet joint injection:
either
* at least 3 months of pain, unresponsive to 6 weeks of conservative therapies, including manual therapy; and
* confounding psychosocial risk factors have been screened for and clinically addressed; and
* physical examination findings are consistent with facet origin pain (e.g., pain on extension with lateral bending and referral patterns consistent with the expected pathologic level) that is affecting activity;
or
* the patient has refused a rhizotomy despite facet origin pain on clinical exam; or
* the patient has facet findings with a thoracic component (tables 44, 45).
Recommendation 102. Repeat facet joint injections are only recommended when the first injection results in a sustained therapeutic response for 3 months or more and is characterized by the following:
* improvement in at least 3 physical examination findings consistent with facet origin pain (e.g., pain on extension with lateral bending and referral patterns consistent with the expected pathologic level), and
* at least 80% improvement in an accepted pain scale (e.g., VAS or NRS).
Functional progress supersedes pain improvement.
Recommendation 103. There is no indication for combined facet injection and medial branch block. Intraarticular facet joint steroid injections are not of diagnostic utility in determining appropriateness for radiofrequency (RF) neurotomy.
Recommendation 104. Facet injections cannot be performed at more than 2 levels, unilaterally or bilaterally.
Time Frames.
Time Frames for Facet Joint Injections | |
Time to produce effect | Maximum duration |
Approximately 30 minutes for local anesthetic; 48 to 72 hours for corticosteroid. | 2 injections per level per year when at least 3 months of functional benefit is documented. Prior authorization must be obtained for injections beyond 2 levels. |
Evidence Tables.
Table 44. Evidence Table: Diagnosis of Facet-Mediated Pain | ||
Some evidence | Evidence statement | Design |
Revel's criteria are unsuitable as a clinical screening test to select chronic low back pain patients for initial zygapophyseal joint blocks. | RCT | |
Table 45. Evidence Table: Effectiveness of Facet Joint Injection | ||
Summary: There is a lack of evidence for therapeutic benefit of intraarticular facet joint injections in treating low back pain. | ||
Some evidence | Evidence statement | Design |
In the setting of axial back pain accompanied by paraspinal tenderness, in which the facet joint is suspected to be involved in the etiology of the pain, the therapeutic effects at 1 month of an intra-articular injection of local anesthetic plus a depot steroid are similar to the effects of a medial branch block using a local anesthetic plus a depot steroid, and both interventions are similar to the injection of a saline solution at the anatomic site used for a medial branch block. In summary, there is some evidence that both interventions lack therapeutic benefit at 1 month. | RCT | |
Lack of evidence | Lack of evidence statement | Design |
A high quality meta-analysis did not provide evidence for any injection therapy (epidural, facet, or local) for non-radicular low back pain. | Meta analysis | |
Introduction. Sacroiliac (SI) joint injection is an injection of local anesthetic and/or corticosteroids in an intra-articular fashion into the SI joint under fluoroscopic guidance.
Contraindications / Complications / Side Effects and Adverse Events.
Absolute and Relative Contraindications to SI Joint Injection.
* Poorly controlled diabetes mellitus, systemic or localized bacterial infection, and bleeding diathesis are absolute contraindications to steroid injections.
* Patients with existing osteoporosis or other risk factors for osteoporosis should rarely receive steroid injections. It is unknown if SI joint injections contribute to increased risk of fractures, but appropriate precautions should be taken for at-risk patients.
* Patients on medications that affect coagulation require special consideration prior to these injections.
* Somatization disorder, poorly controlled congestive heart failure, and uncontrolled hypertension are relative contraindications to these injections. Allergy to contrast material may be a contraindication if alternative contrast material is unavailable.
Complications of SI Joint Injection.
* Complications include nerve injury, bleeding, infection, localized pain, or irritation.
* Extravasation of local anesthetic to the lumbar nerves may result in difficulty in ambulation.
* Extravasation to the sacral nerves may result in bowel and bladder impairment.
Side Effects and Adverse Events Related to SI Joint Injection.
* Diabetic patients may notice a steroid-induced effect on blood glucose levels in the post-injection period.
Recommendations.
Core Requirements.
Recommendation 105. The following requirements must be met prior to proceeding with a SI joint injection:
* at least 3 months of pain, unresponsive to 6 weeks of conservative therapies, including manual therapy;
* confounding psychosocial risk factors have been screened for and clinically addressed; and
* 3 positive physical examination findings are consistent with SI joint origin pain (i.e., compression test, thigh thrust test, sacral thrust test, Patrick's, Gaenslen test, distraction test, Gillett test) for SI joint pain that is affecting activity.
Recommendation 106. Repeat SI joint injections are only recommended when the first injection resulted in a sustained therapeutic response for 3 months or more and is characterized by the following:
* improvement in at least 3 physical examination findings consistent with SI joint origin pain (e.g., Patrick's sign, Gaenslen, distraction or gapping, or compression test), and
* at least 80% improvement in an accepted pain scale (e.g., VAS or NRS).
Functional progress supersedes pain improvement.
Time Frames.
Time Frames for SI Joint Injections | ||
Time to produce effect | Frequency | Maximum duration |
Approximately 30 minutes for local anesthetic; 48 to 72 hours for corticosteroid. | 2 to 3 injections per year. | 3 injections per year. |
Evidence Table.
Table 46. Evidence Table: Imaging Guidance for SI Joint Injection | ||
Summary: For SI joint injections, there may be minimal difference between the use of fluoroscopic guidance and the use of ultrasound guidance in the effects on function or pain. | ||
Some evidence | Evidence statement | Design |
SI joint injection with ultrasound is likely to be less accurate than fluoroscopic guidance in terms of intra-articular placement, since some of the injected solution may reach the periarticular structures. However, the significance of this difference in terms of pain relief and functional improvement is not clear. | RCT | |
In the setting of SI joint pain in nonobese patients with pain duration of approximately 6 months, intra-articular injection of lidocaine and dexamethasone is similarly effective when guidance of the needle is done with either ultrasound or fluoroscopy, and radiation exposure is absent with ultrasound. | RCT | |
In the setting of steroid and local anesthetic injection into the SI joint, the difference in pain relief at 1 month is likely to be no greater than 30% between guidance using ultrasound and guidance using fluoroscopy; however, there is a lack of evidence that either method of injection improves disability associated with SI joint pain. There is a lack of evidence that pain relief persists beyond 1 month. | RCT | |
Introduction. Intradiscal steroid injection is a direct injection of a steroid-containing solution into an intervertebral disc.
Contraindications / Complications / Side Effects and Adverse Events.
Complications of Intradiscal Steroid Injection.
* Complications include infection, pain, bleeding, nerve injury, and allergic reaction to contrast dye.
Recommendations.
Core Requirements.
Recommendation 107. Intradiscal injections are not recommended (table 47).
Evidence Table.
Table 47. Evidence Table: Intradiscal Steroid Injection | ||
Good evidence | Evidence statement | Design |
Intradiscal steroid injection is unlikely to relieve pain or provide functional benefit in patients with non-radicular back pain and therefore, they are not recommended. | RCT | |
Introduction. Medial branch blocks are diagnostic injections used to determine whether a patient is a candidate for radiofrequency (RF) medial branch neurotomy. Medial branch neurotomy, also known as facet rhizotomy, is a procedure designed to denervate the facet joint by ablating the corresponding sensory medial branches. Continuous thermal percutaneous RF is the method frequently used. See the Chronic Pain Disorder Medical Treatment Guidelines (MTGs) for information on the use of repeat RF neurotomy in chronic pain maintenance management.
Contraindications / Complications / Side Effects and Adverse Events.
Absolute and Relative Contraindications to Medial Branch Block or RF Neurotomy.
* Systemic or localized bacterial infection and bleeding diathesis are absolute contraindications to medial branch blocks and RF neurotomy. Poorly controlled diabetes is a relative contraindication if steroids are used post-neurotomy.
* Allergy to contrast material may be a contraindication if alternative contrast material is unavailable.
Complications of Medial Branch Block or RF Neurotomy.
* Complications of medial branch block or RF neurotomy include bleeding, infection, neural injury, localized neuritis, or rarely, a deafferentation centralized pain syndrome.
* Complications of repeat neurotomy include atrophy of spinal musculature.
Side Effects and Adverse Events Related to Medial Branch Block or RF Neurotomy.
* Side effects and adverse events related to medial branch block or RF neurotomy include localized pain at the injection and/or RF site and post-injection dysesthesia.
Recommendations.
Diagnostics Medial Branch Block Requirements.
Recommendation 108. Diagnostic medial branch blocks are recommended when all of the following are present:
* physical examination findings consistent with facet origin pain (e.g., pain with extension greater than flexion, pain on extension with lateral bending, and referral patterns consistent with the expected pathologic level);
* at least 3 months of pain, unresponsive to 6 to 8 weeks of conservative therapies, including manual therapy; and
* confounding psychosocial risk factors have been screened for and clinically addressed. See the Behavioral and Psychological Interventions section.
Recommendation 109. Diagnostic medial branch blocks are limited to 2 anatomic facet joint levels or 3 medial branch levels. Bilateral controlled blocks are permitted, if performed in a way that preserves diagnostic accuracy.
Recommendation 110. A diagnostic response to medial branch blocks must be documented to show its value, including:
* improvement in at least 3 objective functional measures (e.g., spinal ROM; tolerance and time limits for sitting, standing, walking, and lifting); and
* at least 80% improvement in an accepted pain scale (e.g., VAS or NRS) reported with post-injection provocative testing that is consistent with:
* the expected duration of the injected local anesthetic phase, and
* a post-injection pain diary with at least 8 hourly response recordings or until the block has clearly worn off.
A successful response to a diagnostic injection requires documentation of positive functional changes by trained personnel and may include nurses, physician assistants, medical assistants, therapists, or non-injectionist physicians. Functional progress supersedes pain improvement (table 48).
Recommendation 111. If the diagnostic response to the initial block is considered positive, then a separate confirmatory block using a local anesthetic of different duration on a different date must be performed to confirm the level of involvement prior to rhizotomy.
RF Neurotomy Requirements.
Recommendation 112. RF neurotomy is not recommended for patients with non-facetogenic pain generators or involvement of more than 3 levels of medial branch nerves.
Recommendation 113. RF neurotomy is only indicated for those with proven facetogenic pain who have met the criteria for a positive response to 2 controlled medial branch blocks, as defined in recommendation 110. Intra-articular facet joint steroid injections are not considered diagnostic blocks for the purposes of this criteria.
Recommendation 114. Cooled RF denervation, pulsed RF, dorsal nerve root ganglion RF ablation, and transdiscal biacuplasty are not recommended for the lumbar spine.
Repeat RF Neurotomy Requirements.
Recommendation 115. Repeat RF neurotomy may be indicated if the patient experiences sustained (6 months or more), measurable, and clinically meaningful improvement in at least 3 objective functional measures (e.g., spinal ROM; tolerance and time limits for sitting, standing, walking, and lifting) and improvement in an accepted pain scale (e.g., VAS or NRS) after initial RF neurotomy (Appendix Functional Screen). Functional progress supersedes pain improvement. The potential for atrophy of the spinal musculature should be factored into clinical decision making.
Recommendation 116. If the patient's pain presents differently than the initial rhizotomy, a confirmatory medial branch block, as outlined in recommendation 110, will be necessary.
Evidence Table.
Table 48. Evidence Table: Medial Branch Blocks and RF Neurotomy at the Lumbar Spine | ||
Summary: Patients with substantial (80%) pain relief after controlled and blinded medial branch blocks who proceed to RF neurotomy experience decreased impairment and improved pain relief over 6 months as compared to sham procedures. Patients who experience higher levels of pain relief with medial branch blocks are more likely to benefit from RF neurotomy. | ||
Good evidence | Evidence statement | Design |
In the lumbar spine, carefully selected patients who had 80% relief with medial branch controlled blinded blocks and then had RF neurotomy had improved pain relief over 6 months and decreased impairment compared to those who had sham procedures. Pain relief was defined as 1 hour of 80% relief from the lidocaine injection and 2 hours of 80% relief with bupivacaine. | RCT | |
RF denervation of the lumbar facet joint with a 22 gauge probe in patients who are selected on the basis of a single medial branch block does not decrease low back pain 3 months after the procedure. | RCT | |
Some evidence | Evidence statement | Design |
RF is more effective than placebo for suspected facet joint pain in the short term, but there is a lack of evidence for its effects on pain and function at other time points. | Meta analysis | |
In the setting of axial back pain accompanied by paraspinal tenderness, in which the facet joint is suspected to be involved in the etiology of the pain, the therapeutic effects at 1 month of an intra-articular injection of local anesthetic plus a depot steroid are similar to the effects of a medial branch block using a local anesthetic plus a depot steroid, and both interventions are similar to the injection of a saline solution at the anatomic site used for a medial branch block. There is some evidence that both interventions lack therapeutic benefit at 1 month. | RCT | |
Introduction. Lateral branch blocks are diagnostic injections used to determine whether a patient is a candidate for radiofrequency (RF) lateral branch neurotomy. Lateral branch neurotomy is a procedure designed to denervate the SI joint by ablating the corresponding sensory lateral branches. See the Chronic Pain Disorder MTGs for information on the use of repeat RF neurotomy in chronic pain maintenance management.
Contraindications / Complications / Side Effects and Adverse Events.
Absolute and Relative Contraindications to Lateral Branch Blocks or RF Neurotomy.
* Systemic or localized bacterial infection and bleeding diathesis are absolute contraindications to lateral branch blocks and RF neurotomy. Poorly controlled diabetes is a relative contraindication if steroids are used post-neurotomy.
* Allergy to contrast material may be a contraindication if alternative contrast material is unavailable.
Complications of Lateral Branch Blocks or RF Neurotomy.
* Complications of lateral branch block or RF neurotomy include bleeding, infection, neural injury, localized neuritis, or rarely, a deafferentation centralized pain syndrome.
* Complications of repeat neurotomy include atrophy of spinal musculature.
Side Effects and Adverse Events Related to Lateral Branch Blocks and RF Neurotomy.
* Side effects and adverse events related to lateral branch block or RF neurotomy include localized pain at the injection and/or RF site and post-injection dysesthesia.
Recommendations.
Diagnostics Lateral Branch Blocks Requirements.
Recommendation 117. Diagnostic lateral branch blocks are recommended when all of the following are present:
* physical examination findings consistent with SI joint origin pain, including 3 positive physical exam maneuvers (e.g., compression test, thigh thrust test, sacral thrust test, Patrick's, Gaenslen test, distraction test, and Gillett test);
* at least 3 months of pain, unresponsive to 6 to 8 weeks of conservative therapies, including manual therapy; and
* confounding psychosocial risk factors are screened for and clinically addressed. See the Behavioral and Psychological Interventions section.
Recommendation 118. Diagnostic lateral branch blocks should be performed in a manner consistent with the planned RF procedure without anesthetizing the nerve root or allowing intraarticular SI joint flow of medication. Bilateral controlled blocks are permitted, if performed in a way that preserves diagnostic accuracy.
Recommendation 119. A diagnostic response to lateral branch blocks must be documented to show its value, including:
* improvement in at least 3 objective functional measures (e.g., tolerance and time limits for sitting, standing, walking, and lifting); and
* at least 80% improvement in an accepted pain scale (e.g., VAS or NRS) reported with post-injection provocative testing that is consistent with:
* the expected duration of the injected local anesthetic phase, and
* a post-injection pain diary with at least 8 hourly response recordings or until the block has clearly worn off.
A successful response to a diagnostic injection requires documentation of positive functional changes by trained personnel and may include nurses, physician assistants, medical assistants, therapists, or non-injectionist physicians. Functional progress supersedes pain improvement (table 49).
Recommendation 120. If the initial block is considered positive, then a separate confirmatory block using a local anesthetic of different duration on a different date must be performed to confirm the level of involvement prior to rhizotomy.
RF Neurotomy Requirements.
Recommendation 121. RF neurotomy is not recommended for patients without sacral nerve branch involvement.
Recommendation 122. RF neurotomy is only indicated for those with proven sacral nerve branch pain who have met the criteria for a positive response to 2 controlled lateral branch blocks, as defined in recommendation 119. Intra-articular SI joint steroid injections are not considered as a diagnostic block for the purposes of this criteria (table 49).
Recommendation 123. Pulsed RF, dorsal nerve root ganglion RF ablation, and transdiscal biacuplasty are not recommended for the lumbar spine.
Repeat RF Neurotomy Requirements.
Recommendation 124. Repeat RF neurotomy may be indicated if the patient experiences sustained (6 months or more), measurable, and clinically meaningful functional improvement in at least 3 objective functional measures (e.g., tolerance and time limits for sitting, standing, walking, and lifting) and improvement in an accepted pain scale (e.g., VAS or NRS) after initial RF neurotomy (Appendix Functional Screens).
Recommendation 125. If the patient's pain presents differently than the initial rhizotomy, a confirmatory lateral branch block, as outlined in recommendation 119, will be necessary.
Evidence Table.
Table 49. Evidence Table: RF Neurotomy at the SI Joint | ||
Summary: Patients with chronic SI joint pain who experience substantial pain relief after local anesthetic lateral branch blocks and proceed to cooled RF neurotomy may have clinical benefit at 3 months post-procedure. | ||
Some evidence | Evidence statement | Design |
RF neurotomy with a cooled probe may benefit patients with chronic SI joint pain who demonstrate at least a 75% pain response to repeated nerve blocks done under fluoroscopic guidance 3 months after the procedure. | RCT | |
RF neurotomy with a cooled probe of the SI joint provides more pain relief than placebo RF at 3 months. | Meta analysis | |
Introduction. Prolotherapy, also known as sclerotherapy, consists of a series of injections of hypertonic dextrose, with or without glycerine and phenol, into the ligaments of the low back.
Contraindications / Complications / Side Effects and Adverse Events.
Side Effects and Adverse Events Related to SI Joint Prolotherapy.
* Side effects and adverse events include a temporary increase in low back pain and stiffness post-injection.
Recommendations.
Core Requirements.
Recommendation 126. Prolotherapy is not recommended for nonspecific low back pain (table 50).
Recommendation 127. Prolotherapy for SI joint pain is generally not recommended. For a patient with SI joint pain to be a candidate for prolotherapy, the provider must document all of the following:
* at least 6 months of persistent functional impairment, unresponsive to intensive conservative therapies;
* localization of reported pain at the posterior superior iliac spine;
* 3 positive physical examination findings consistent with SI joint origin pain (e.g., compression test, thigh thrust test, sacral thrust test, Patrick's, Gaenslen test, distraction test, or Gillett test);
* imaging and/or laboratory studies fail to reveal other sources that might better explain the symptoms;
* psychological evaluation and treatment, as appropriate; and
* positive response to initial and confirmatory fluoroscopically-guided SI joint local anesthetic blocks, consisting of:
* documented improvement in previously impaired SI joint function and provocative physical examination maneuvers within expected time frame of local anesthetic (e.g., spinal ROM; tolerance and time limits for sitting, standing, walking, and lifting; Patrick's sign; Gaenslen; distraction; gapping and compression tests); and
* 80% improvement in accepted pain scales (e.g., VAS or NRS), consistent with:
* the expected duration of the injected local anesthetic phase, and
* a post-injection pain diary with at least 8 hourly response recordings or until the block has clearly worn off.
Functional progress supersedes pain improvement.
Evidence Table.
Table 50. Evidence Table: Prolotherapy | ||
Summary: Prolotherapy is not effective for treating non-specific low back pain, but it may provide a longer duration of pain relief than intra-articular steroid injections for SI joint pain. | ||
Good evidence | Evidence statement | Design |
Prolotherapy alone is not an effective treatment for chronic low back pain. | Systematic review | |
Some evidence | Evidence statement | Design |
Prolotherapy of the SI joint is longer lasting, up to 15 months, than intra-articular steroid injections. The study was relatively small and long term blinding was unclear; however, all injections were done under fluoroscopic guidance. | RCT | |
Introduction. Trigger point injections consist of injection of local anesthetic, with or without corticosteroid, into highly localized, extremely sensitive bands of skeletal muscle fibers that produce local and referred pain when activated.
Contraindications / Complications / Side Effects and Adverse Events.
Absolute and Relative Contraindications to Trigger Point Injection.
* Contraindications include underlying structural issues that more reasonably account for myofascial pain or infection.
Complications of Trigger Point Injection.
* Complications include infection, pneumothorax, anaphylaxis, penetration of the viscera, neurapraxia, neuropathy, syncope, and/or local myopathy (when corticosteroid injected).
Side Effects and Adverse Events Related to Trigger Point Injection.
* Side effects and adverse events include localized pain.
* If a patient experiences severe pain, there is a possibility of intraneural injection and the needle should be immediately repositioned.
Recommendations.
Core Requirements.
Recommendation 128. Trigger point injections should be reserved for patients who meet all of the following criteria:
* consistent, well circumscribed trigger points with a local twitch response;
* characteristic radiation of pain pattern and local autonomic reaction (e.g., persistent hyperemia following palpation); and
* trigger points are not responding to specific, noninvasive, myofascial interventions within a 6-week time frame (table 51).
Recommendation 129. Concurrent participation in a therapeutic exercise program is required while undergoing myofascial interventions. See the Active Therapies section.
Recommendation 130. Conscious sedation is not recommended for patients receiving trigger point injections.
Time Frames.
Time Frames for Trigger Point Injection | |||
Time to produce effect | Frequency | Optimum duration | Maximum duration |
Local anesthetic - up to 30 mins No local anesthetic - up to 48 hrs | Weekly* | 4 weeks | 8 weeks[DAGGER] |
*No more than 4 injections per session per week to avoid significant post-injection soreness. [DAGGER]Occasional patients may require 2 to 4 repetitions of trigger point injections series over a 1 to 2 year period. | |||
Evidence Table.
Table 51. Evidence Table: Trigger Point Injection | ||
Lack of evidence | Lack of evidence statement | Design |
A high quality meta-analysis did not provide evidence for any injection therapy (epidural, facet, or local) for non-radicular low back pain. | Meta analysis | |
Introduction. Botulinum toxin injections are used to temporarily weaken or paralyze muscles. These injections may reduce muscle pain in conditions associated with spasticity or dystonia.
Contraindications / Complications / Side Effects and Adverse Events.
Absolute Contraindications to Botulinum Toxin Injection.
* Absolute contraindications include hypersensitivity to any botulinum toxin preparation or any of the components in the formulation.
* Infection at the proposed injection site.
* Motor neuropathy or neuromuscular junction disorders.
Complications of Botulinum Toxin Injection.
* Complications of infection at the injection site.
Side Effects and Adverse Events Related to Botulinum Toxin Injection.
* Side effects and adverse events include flu-like symptoms, dry mouth, dysphagia, weakening of the paralumbar musculature, and localized muscular tenderness at the site of injection.
* Neutralizing antibodies develop in at least 4% of patients treated with botulinum toxin type A, rendering it ineffective. Several antigenic types of botulinum toxin have been described. Botulinum type B appears to be effective in patients who have become resistant to the type A toxin. The immune responses to botulinum toxins type A and B are not cross-reactive, allowing type B toxin to be used when type A action is blocked by antibodies.
Recommendations.
Core Requirements.
Recommendation 131. Botulinum injections are not recommended for nonspecific low back pain.
Evidence Table. None. The above recommendation was based on consensus.
Introduction. Operative treatments are considered when the natural history for surgically treated lesions is better than that of non-operatively treated lesions. Most individuals with low back pain will not need a surgical intervention. See the Overview of Care section.
Contraindications / Complications / Side Effects and Adverse Events.
* See specific surgical procedure section.
Recommendations.
Core Requirements.
Recommendation 132. Early surgical evaluation is required for patients with evidence of any of the following:
* acute fracture or dislocation,
* epidural abscess,
* myelopathy,
* cauda equina syndrome, or
* progressive neurologic deficits (e.g., motor weakness and reflexes) that specifically correlate with spinal cord or nerve root impingement.
Recommendation 133. Referral for surgical evaluation at 6 weeks or greater is indicated when the expected functional outcome of surgery is better than non-operative management and all of the following criteria are met:
* symptomatic and functional improvement has plateaued with unacceptable functional disability;
* greater pain in the legs relative to back that interferes with function, return to work, and/or active therapy;
* physical exam findings of abnormal reflexes, motor weakness, or radicular sensation deficits;
* findings on MRI that indicate impingement of nerves or the spinal cord that specifically correlate with reproducible physical examination findings; and
* diagnostic elimination of confounding psychological or physical conditions that may respond to non-surgical techniques or may be refractory to surgical intervention (see the Behavioral and Psychological Interventions section).
Recommendation 134. Continuation of exercise and/or active therapy while awaiting a surgical evaluation or surgical procedure is recommended to maintain and optimize physical conditioning.
Recommendation 135. Informed consent is required before all invasive procedures. See the Essential First Line Treatment section.
Recommendation 136. Participation in a postoperative active therapy program that includes core stabilization, strengthening, and endurance is strongly recommended. See the Active Therapies section.
Recommendation 137. Diabetes control and related routine lab work, including hemoglobin A1c, are recommended prior to surgery.
Recommendation 138. A multi-modal approach to postoperative pain management is recommended to avoid overuse and misuse of opioid medications. This approach may include any of the following:
* cognitive behavioral therapy (CBT) (see the Behavioral and Psychological Interventions section);
* pain neuroscience education (see tlie Active Tlierapies section):
* use of non-opioid medication strategies as adjunct to anesthesia and pre- or postoperative pain management (see tlie IVIedications section):
* use of peripheral regional analgesia: and/or
* use of passive therapy for postoperative pain (see the Passive Therapies section).
Recommendation 139. Intraoperative neuromonitoring is permitted to evaluate spinal cord integrity and screw placement during the operative procedure.
Recommendation 140. Percutaneous RF disc decompression and intradiscal electrothermal therapy are not recommended.
Evidence Table.
Table 52. Evidence Table: Factors Influencing Surgical Outcomes | ||
Strong evidence | Evidence statement | Design |
Surgical interventions for low back pain with radiculopathy produce large and clinically important reductions in pain and disability 3 months after surgery. However, pain and disability are not entirely eliminated in the long term, and mild to moderate pain and disability, approximately on the order of 15 to 20 points on a 100 point scale, can be expected to be present 5 years after surgery for most patients who have a successful surgical procedure for low back pain with radiculopathy. | Systematic review | |
Good evidence | Evidence statement | Design |
Functional improvement and relief of back pain from most back surgery is similar between patients with a body mass index (BMI) under 25 and overweight or mildly obese patients with a BMI between 25 and 35. Mild obesity does not appear to have an adverse effect on the responsiveness to surgery for these clinical outcomes. | Systematic review | |
Introduction. Discectomy is a surgical treatment for ruptured or herniated discs of the lumbar spine. There are several procedures in use to decompress extruded disc material around nerve roots, including several minimally invasive techniques. These include:
* lumbar microscopic discectomy,
* percutaneous discectomy,
* microdiscectomy, and
* laser discectomy.
Contraindications / Complications / Side Effects and Adverse Events.
Complications of Lumbar Discectomy.
* Complications of open discectomy include nerve damage, spinal fluid leakage, disc reherniation requiring additional surgery, spinal instability, persistent disc related back pain, infection, and hemorrhage.
* Complications of percutaneous discectomy include nerve or vessel injury, infection, hematoma, incomplete nerve root dissection, disc reherniation requiring additional surgery, spinal instability, and persistent disc related back pain.
Recommendations.
Core Requirements.
Recommendation 141. A psychological screen with a follow-up psychological evaluation, if indicated, is required prior to proceeding with discectomy. If the surgery is being performed in an emergent or urgent situation, the screen is not necessary.
Recommendation 142. For a patient to be a candidate for open or minimally invasive lumbar discectomy, the provider must document all of the following:
* subjective report of severe radicular pain;
* positive straight leg raise or femoral stretch test and/or reflex, motor, or sensory changes on examination consistent with imaging findings; and
* objective findings of neural compression on imaging studies that specifically correlate with the subjective report and examination findings (table 53).
Recommendation 143. ESIs can be trialed prior to surgery if the patient has a preference to avoid surgery, is unable to participate in therapy after the first 2 weeks post-injury, and meets the criteria for ESI outlined in recommendation 94.
Recommendation 144. The decision to proceed with an open or minimally invasive technique for lumbar discectomy is left to the treating surgeon's discretion, experience, and training in these techniques (tables 54, 55).
Acute Phase Requirements (Within 6 Weeks of Initial Care).
Recommendation 145. Early referral within 6 weeks for lumbar discectomy is permitted when the provider documents all criteria in recommendations 141 and 142 and at least 1 of the following:
* radicular pain-related functional impairment prevents participation in active therapy and ADLs;
* presence of progressive functional neurological deficits; or
* an opioid treatment is being considered.
Subacute and Chronic Phase Requirements (After 6 Weeks of Care).
Recommendation 146. Referral for lumbar discectomy is permitted for patients who meet the criteria in recommendation 142 and both of the following:
* functional impairment despite 6 weeks of optimal medical management and participation in active therapy; and
* confounding psychosocial risk factors have been screened for and clinically addressed (see the Behavioral and Psychological Interventions section).
Recommendation 147. Laser discectomy and percutaneous discectomy are not recommended.
Evidence Tables.
Table 53. Evidence Table: Effectiveness of Lumbar Discectomy | ||
Summary: In patients with persistently symptomatic subacute or chronic radiculopathy attributable to disc herniation, discectomy results in greater functional improvement and pain reduction compared to nonoperative management. However, it is reasonable to trial an ESI for patients who prefer to avoid surgery without concern for reducing later surgical success. An ESI may allow patients to avoid surgery. | ||
Good evidence | Evidence statement | Design |
In patients with sciatica arising from a posterolateral disc herniation at L4-5 or at L5-S1 lasting 4 to 12 months, microdiscectomy leads to greater pain reduction and functional improvement than nonoperative treatment when these outcomes are assessed 6 to 12 months after the initiation of treatment. | RCT | |
Good evidence cont. | Among patients with herniated discs who have remained symptomatic after 6 weeks of noninvasive care and who are likely candidates for surgery, surgical discectomy successfully leads to symptom resolution in a large majority of patients. However, patients from the same population who receive ESI after 6 weeks of unsuccessful noninvasive care frequently experience symptom resolution sufficiently well to be able to avoid surgery. The magnitude of the surgery-sparing effect of ESI has not been established, but as many as half of patients may avoid surgery for up to 3 years. Patients who have an unsuccessful ESI after 6 weeks of noninvasive care may undergo discectomy at a later time, with no evidence that the delay in surgery reduces the success of the later operation. | Systematic review |
In the setting of lumbar microdiscectomy in which a large annular defect 4-6 mm in height and 6-10 mm in width is present, the risk of reherniation and reoperation may be significantly reduced by repair of the disc annulus with a mesh device, which is fixed to the adjacent vertebral body with a titanium anchor. The number needed to treat to prevent a reherniation may be approximately 8 and the number needed to treat to prevent a reoperation may be approximately 13. | RCT | |
Open discectomy is likely to benefit patients with imaging-confirmed lumbar disc herniations who are failing to improve with several weeks of conservative treatment. | RCT | |
Some evidence | Evidence statement | Design |
The advantages of surgical over nonoperative treatment of herniated lumbar discs remain stable over an 8 year period following randomization to either surgery or nonoperative treatment, and the gains observed at 2 years do not deteriorate in the long term. | RCT | |
Table 54. Evidence Table: Minimally Invasive Microdiscectomy versus Open Lumbar Discectomy | ||
Summary: Minimally invasive and open discectomy techniques appear to result in similar clinical outcomes, but there may be lower risk of surgical site infection with minimally invasive techniques. | ||
Some evidence | Evidence statement | Design |
Minimally invasive discectomy is associated with a lower risk of surgical site infection than conventional microdiscectomy and open discectomy. | Systematic review | |
Clinical outcomes such as leg pain, back pain, and functional disability are similar between minimally invasive discectomy and conventional microdiscectomy and open discectomy. | Systematic review | |
Some evidence cont. | Minimally invasive discectomy has not been shown to improve function, extremity pain, or axial pain compared to open discectomy in the setting of cervical and lumbar primary discectomy. | Systematic review |
Table 55. Evidence Table: Intraoperative and Perioperative Factors in Discectomy Outcome | ||
Some evidence | Evidence statement | Design |
In the setting of percutaneous lumbar discectomy, an epidural saline solution containing 40 mg of triamcinolone may reduce leg pain and disability during the first postoperative week, leading to earlier hospital discharge. However, there is insufficient information regarding the safety of epidural steroid administration with respect to wound healing and the risk of reherniation. | RCT | |
Preoperative administration of dexamethasone reduced acute pain during movement 2 to 24 hours postoperatively from lumbar disc surgery as measured by the VAS. | RCT | |
Intraoperative application of epidural corticosteroids such as DepoMedrol reduces postoperative pain for up to 1 month in patients who have undergone lumbar discectomy at either L3/L4 or L4/L5. | RCT | |
Following a surgical intervention for first time lumbar disc herniation, patients are likely to achieve functional and symptomatic benefits from a 12 week, 20 session program of a physical therapy based rehabilitation intervention. This program emphasizes supervised exercise activities aimed at the core stabilizers, reduces fear of movement, and also coaches patients on the best ergonomic practices for return to work. | RCT | |
Table 56. Evidence Table: Postoperative Factors Influencing Discectomy Outcome | ||
Good evidence | Evidence statement | Design |
Among patients with a preoperative diagnosis of lumbar disk herniation, a program of early comprehensive physiotherapy commenced within 4 weeks after discectomy (or microdiscectomy) did not increase the rate of reherniation, reoperation, and revision surgery as compared to a control treatment. | Systematic review | |
Some evidence | Evidence statement | Design |
In the setting of elective open single-lumbar discectomy for herniated discs, where morphine is delivered by patient-controlled anesthesia, a low-dose separate infusion of 0.25 mcg/kg/hour of naloxone in the 24 hours after surgery may reduce morphine consumption and reduce postoperative pain, nausea, and pruritus. | RCT | |
In the setting of lumbar discectomy for herniated discs, a postoperative rehabilitation program consisting of in-hospital instructions for transfers (bed to chair, etc) and ADLs can lead to successful recovery if supplemented by an instructional booklet with information about core strengthening and mobilization. The addition of an immediate exercise rehabilitation program in the first 6 to 8 weeks following surgery adds very little additional benefit and is not likely to be cost-effective. | RCT | |
Introduction. Multiple procedures described in this section offer surgical access to decompress neural elements by partial or total removal of various parts of the spinal elements. These procedures include:
* laminotomy,
* laminectomy,
* foraminotomy,
* facetectomy, and
* ligamentum flavum resection.
Contraindications / Complications / Side Effects and Adverse Events.
Absolute and Relative Contraindications to Decompressive Surgery.
* Unaddressed depression, unaddressed concomitant disorder influencing walking capacity (e.g., hip or knee arthrosis, neurologic disease, and cardiopulmonary disease), and unaddressed cardiovascular comorbidity are relative contraindications.
* Scoliosis is a relative contraindication for laminectomy.
* Laminectomy is contraindicated for patients with dynamic spinal instability.
Complications of Decompressive Surgery.
* Complications include graft dislodgement, nerve injury, post-surgical instability, cerebrospinal fluid leakage, hematoma, hemorrhage, infection, spinal cord injury causing paralysis, perineural fibrosis, ROM loss, incomplete decompression, and development of spinal instability requiring fusion surgery.
Recommendations.
Core Requirements.
Recommendation 148. A psychological screen with a follow-up psychological evaluation, if indicated, is required prior to proceeding with decompressive surgery. If the surgery is being performed in an emergent or urgent situation, the screen is not necessary (table 57).
Recommendation 149. Surgical indications include all of the following:
* radicular symptoms or symptoms of neurogenic claudication, often with clinical evidence of radiculopathy that correlates with the patient's pain and findings;
* evidence of nerve root or spinal compression on imaging studies; and
* failure of non-surgical care, including a trial of 6 weeks of active therapy (table 58).
Evidence Tables.
Table 57. Evidence Table: Factors Influencing Surgical Outcomes | ||
Summary: Patients undergoing spinal surgery who have perioperative depression may have poorer functional outcomes than those without depression. | ||
Some evidence | Evidence statement | Design |
Depression at the time of surgery and in the early recovery period is associated with poorer functional recovery at 2 years, even though it does not appear to be associated with worse pain at 2 years. | Cohort study | |
Depression at the time of operation and in the early postoperative period predicts poorer functional recovery from lumbar spinal stenosis surgery. | Cohort study | |
Table 58. Evidence Table: Decompressive Surgery Versus Non-Operative Care for Spinal Stenosis | ||
Summary: Some patients with lumbar spinal stenosis respond favorably to non-operative management, while others eventually progress to surgery. Surgical treatment is more likely to result in functional improvement and pain relief for the first several years compared with non-operative management, but the benefits become equivalent after 5-8 years. | ||
Good evidence | Evidence statement | Design |
Surgical treatment of lumbar spinal stenosis leads to better symptomatic and functional outcomes, but patients with non-surgical treatment may also improve slightly. The non-operative improvement appears to be less likely for stenosis than for herniated discs. In a randomized spinal stenosis trial with crossover, 1/3 of those in the surgery group did not have surgery, and about 40% of those in the non-surgical group eventually had surgery. | RCT | |
In the setting of lumbar spinal stenosis with neurogenic claudication, an initial treatment plan for a decompressive laminectomy and an initial treatment plan for nonoperative treatment with active physical therapy, educational counseling, and home exercise are likely to be equally successful, provided that these plans are allowed to change if circumstances change, that is, if surgery is done when nonoperative treatment is not meeting with success, and if plans for surgery are changed if a patient is improving with nonoperative treatment. | RCT | |
Although surgery for spinal stenosis generally leads to greater benefits than nonoperative treatment for the first several years of treatment, the results of the treatment options tend to converge over a period of 5 to 8 years. | RCT | |
Good evidence cont. | In patients with a confirmed diagnosis of stenosis who elect for spinal decompression surgery, a physiotherapist-led program consisting of active rehabilitation was found to improve function up to 12 months after the surgery. The programs ranged from 30 to 90 minutes per week or on a biweekly basis, lasting up to 12 weeks. | Systematic review |
Some evidence | Evidence statement | Design |
Although decompressive laminectomy for spinal stenosis with neurogenic claudication is beneficial in terms of pain relief and improved function, the proportion of patients who consider themselves to be greatly improved from baseline tends to decline over a period of 8 years. | RCT | |
Table 59. Evidence Table: Decompressive Surgery | ||
Evidence statement | Design | |
Good evidence | In patients with lumbar spinal stenosis, with or without spondylolisthesis, the 2-year disability outcomes as measured by the ODI do not differ in a clinically important manner between decompression surgery alone and decompression with added fusion surgery. | RCT |
In comparison with facet-sparing laminectomy, surgical procedures that preserve the spinous processes and other posterior elements of the spine are at least as effective as laminectomy in reducing disability and leg pain when used to treat symptomatic lumbar spinal stenosis. | Systematic review | |
Compared to a fluoroscopically guided interlaminar ESI, a minimally invasive percutaneous partial resection of the ligamentum flavum leads to greater functional improvement and reduced pain at 6 and 12 months in patients with lumbar spinal stenosis and neurogenic claudication accompanied by confirmed hypertrophy of the ligamentum flavum. There is good evidence that these improvements remain stable 24 months following the procedure. However, there is no evidence that the surgical procedure reduces medication use compared to the ESI. | RCT | |
Some evidence | Evidence statement | Design |
In patients with spinal stenosis associated with degenerative spondylolisthesis not exceeding 3 mm of motion on flexion-extension films, an operation involving decompressive laminectomy and instrumented posterolateral fusion leads to slightly greater improvements in general health-related quality of life than decompressive laminectomy alone, with no evidence of clinically important differences in back-specific disability as measured by the ODI. | RCT | |
Some evidence cont. | In comparison with facet-sparing laminectomy, surgical procedures that preserve the spinous processes and other posterior elements of the spine may reduce postoperative instability of the operated segment when treating lumbar spinal stenosis. | Systematic review |
Introduction. Spinal fusion is a procedure that unites 2 or more vertebral bodies together to restrict motion and removes a degenerative disc to relieve symptoms of coexistent nerve root compression. The procedure often involves the use of bone grafts, and sometimes instrumentation, to produce a rigid connection between 2 or more adjacent vertebrae. Recombinant human bone morphogenetic protein-2 (rhBMP-2) may also be used in fusion. Discography is rarely used as an invasive diagnostic procedure for fusion candidates.
Contraindications / Complications / Side Effects and Adverse Events.
Absolute and Relative Contraindications to Lumbar Fusion and Discography.
* Morbid obesity is a relative contraindication to fusion (table 60).
* Absolute contraindications to the use of rhBMP-2 include known sensitivities to rhBMP-2, bovine type 1 collagen, or other components of the formulation.
* Contraindications to discography include infection, bleeding diathesis, significant spinal stenosis, clinical myelopathy, known allergic reaction to injectate, effacement of the cord, thecal sac, or circumferential absence of epidural fat.
Complications of Lumbar Fusion and Discography.
* Potential complications include instrumentation failure, pseudoarthrosis, superficial or deep wound infection, iliac crest bone graft donor site pain graft extrusion, acceleration of adjacent segment disease, and nerve damage.
* Potential complications associated with the use of rhBMP-2 include:
* development of sensitization to rhBMP-2 or to absorbable collagen sponge, and
* neurovascular encroachment due to swelling and ectopic bone formation associated with the use of rhBMP-2 outside of the anterior cage.
* Potential complications of lumbar discography include discitis, nerve damage, chemical meningitis, pain exacerbation, disc damage, and anaphylaxis (table 62).
Recommendations.
Core Requirements.
Recommendation 150. Lumbar fusion is not recommended in the first 6 months of symptoms, except for fracture, dislocation, or for some patients with functional loss due to stenosis and instability.
Recommendation 151. Psychological evaluation is required to assess suitability for a lumbar fusion. Documentation should include the following items with associated treatment recommendations:
* psychological factors that might influence elective surgical treatment outcomes, or
* psychological factors that might complicate surgical recovery.
Confounding depression or anxiety must be addressed prior to proceeding with surgery. Presurgical psychological evaluation should not be done by a psychologist employed by the physician performing the procedure. See the Behavioral and Psychological Interventions section (table 61).
Recommendation 152. The following are required prior to proceeding with spinal fusion:
* all pain generators are adequately defined and treated;
* all physical medicine and manual therapy interventions are completed;
* imaging studies demonstrate spinal stenosis with instability or disc pathology, requiring decompression;
* spine pathology is limited to 2 levels; and
* psychological evaluation, as discussed in recommendation 151 (tables 64, 65, 66, 67).
Recommendation 153. Diagnostic indications for fusion include the following:
* neural arch defect with associated stenosis or instability;
* spondylolytic spondylolisthesis;
* degenerative spondylolisthesis 4 mm or greater;
* surgically induced segmental instability;
* symptomatic spinal stenosis in the presence of spondylolisthesis (>2 mm); or
* primary mechanical low back pain / functional spinal unit failure with objective evidence of 2 or more of the following:
* internal disc disruption (poor success rate if more than 1 disc involved),
* painful motion segment,
* disc resorption,
* facet syndrome, and/or
* ligamentous tear.
Recommendation 154. Discography is not generally recommended, but it is permitted when confirmatory information is necessary prior to proceeding with lumbar fusion (table 62).
Recommendation 155. Tobacco cessation for at least 6 weeks prior to fusion is required, unless the surgeon documents reasoning that the benefits of proceeding with surgery outweigh the risks.
Recommendation 156. The choice of bone graft donor site, grafting substance, operative technique, and surgical approach are at the discretion of the treating surgeon (tables 68, 69).
Recommendation 157. Strategic perioperative medication use is recommended for pain management to minimize opioid use and optimize surgical outcome (table 70).
Recommendation 158. Postoperative participation in an active therapy program that includes core stabilization, strengthening, and endurance is recommended. See the Active Therapies section (table 71).
Evidence Tables.
Table 60. Evidence Table: Complications Related to Lumbar Fusion | ||
Some evidence | Evidence statement | Design |
Morbid obesity increases hospital length of stay, mortality, and postoperative complications after spinal fusion surgery, with concomitant increases in hospital costs. | Cross sectional study | |
Table 61. Evidence Table: Factors Influencing Surgical Outcomes | ||
Summary: Depression at the time of surgery predicts a worse functional outcome. | ||
Some evidence | Evidence statement | Design |
Depression at the time of surgery and in the early recovery period is associated with poorer functional recovery at 2 years, even though it does not appear to be associated with worse pain at 2 years. | Cohort study | |
Some evidence cont. | Depression at the time of operation and in the early postoperative period predicts poorer functional recovery from lumbar spinal stenosis surgery. | Cohort study |
Table 62. Evidence Table: Discography | ||
Summary: Radiographically identified spondylolisthesis more accurately identifies patients who are likely to benefit from fusion than a positive discogram. Discography may result in an increased risk of later disc herniation. | ||
Good evidence | Evidence statement | Design |
A positive discogram does not identify patients who benefit from fusion, in contrast to radiographically identified spondylolisthesis, which does identify patients likely to benefit. Only 27% of "discogenic" pain patients had successful outcomes effusion, even when predictors of a poor outcome were excluded from surgery; 72% of spondylolisthesis patients had success with the same surgery. | Cohort study | |
Some evidence | Evidence statement | Design |
Provocative discography, facet joint blocks, and temporary external transpedicular fixation do not adequately screen patients with nonspecific low | Systematic review | |
back pain for fusion success. The tests tend to be sensitive but not specific. | ||
Discography with a small-bore needle increases the risk of later disc herniation at the level of the injected disc, and this risk should be taken into account when deciding on referral for discography. | Cohort study | |
Table 63. Evidence Table: Factors Predicting Response to Fusion | ||
Good evidence | Evidence statement | Design |
Patients undergoing rehabilitation comprised of exercise and CBT have lower levels of self-reported disability and reduced fear avoidance behavior than patients receiving usual care for up to 12 months following lumbar fusion surgery. | Systematic review | |
Table 64. Evidence Table: Nonoperative Treatment Versus Lumbar Fusion | ||
Summary: For patients with severe symptoms due to lumbar stenosis and spondylolisthesis, decompression and fusion provide greater benefit than nonoperative treatment. For chronic non-radicular back pain without stenosis or instability, intensive exercise combined with cognitive interventions may be as effective as posterolateral fusion. | ||
Good evidence | Evidence statement | Design |
Decompression and fusion, with or without instrumentation, of lumbar stenosis with degenerative spondylolisthesis leads to better 2 year outcomes for patients whose symptoms are severe. However, patients who choose non-operative treatment can also expect their symptoms to improve with nonsurgical treatment, and nonoperative treatment is acceptable if this is the patient preference. | RCT | |
Some evidence | Evidence statement | Design |
Intensive exercise for approximately 25 hours per week for 4 weeks, combined with cognitive interventions emphasizing the benefits of maintaining usual activity, produces functional results similar to those of posterolateral fusion in patients with chronic non-radicular back pain and no stenosis or instability after 1 year. | RCT | |
Intensive exercise coupled with CBT is as effective as posterolateral fusion for chronic un-operated low back pain. | RCT | |
Fusion is likely to have a higher beneficial effect compared to multidisciplinary rehabilitation for patients with isthmic spondylolisthesis, as differentiated from those without the condition who suffered from chronic low back pain. | Systematic review | |
In patients scheduled for lumbar spinal fusion surgery, a 4-week preoperative program of multidisciplinary CBT, emphasizing the interactions between cognition and pain perception, coping strategies for dealing with pain, pacing principles, return to work, and details about the fusion operation, does not | RCT | |
appear to reduce pain scores in the immediate postoperative period. However, such a CBT program as preparation for surgery does appear to be advantageous in the first 3 days after surgery by leading to earlier mobilization and independent ambulation, even though the intensity of pain scores is not significantly reduced. | ||
Lumbar fusion produces better symptomatic and functional results in patients with chronic nonradicular pain when several months of conservative treatment have not produced a satisfactory outcome. | Systematic review | |
Table 65. Evidence Table: Lumbar Fusion With or Without Decompression | ||
Summary: In patients with degenerative spondylolisthesis and minimal instability, the addition of fusion to decompression surgery: * may improve general health-related quality of life; * provides no added benefit for function, pain, rates of complication or rates of reoperation; and * increases operative blood loss, operative time and length of stay. In patients with lumbar spinal stenosis, the addition of fusion to decompression surgery provides no added benefit for function or pain. | ||
Strong evidence | Evidence statement | Design |
In patients with degenerative spondylolisthesis and minimal instability (motion of <= 3 mm on flexion-extension films), decompression alone is as beneficial as decompression plus fusion for outcomes such as disability, leg and back pain, and rates of complication and reoperation. | Systematic review | |
Good evidence | Evidence statement | Design |
In patients with degenerative spondylolisthesis and minimal instability (motion of <= 3 mm on flexion-extension films), decompression alone is associated with less operative blood loss, shorter operative time, and shorter length of stay than decompression plus fusion. | Systematic review | |
In patients with lumbar spinal stenosis, with or without spondylolisthesis, the 2-year disability outcomes as measured by the ODI do not differ in a clinically important manner between decompression surgery alone and decompression with added fusion surgery. | RCT | |
In the setting of symptomatic lumbar spinal stenosis, the addition of a fusion procedure to a decompression procedure adds little additional benefit with respect to pain and disability, both in the short term and in the long term. | Systematic review | |
Some evidence | Evidence statement | Design |
In patients with spinal stenosis associated with degenerative spondylolisthesis not exceeding 3 mm of motion on flexion-extension films, an operation involving decompressive laminectomy and instrumented posterolateral fusion leads to slightly greater improvements in general health-related quality of life than decompressive laminectomy alone, with no evidence of clinically important differences in back-specific disability as measured by the ODI. | RCT | |
Table 66. Evidence Table: Lumbar Fusion Versus Other Surgical Options | ||
Summary: Fusion surgery, the use of interspinous spacers, and total disc replacement (TDR) result in similar improvements in function and pain. For patients with painful degenerative disc disease, but without facet arthritis, spondylolysis, spondylolisthesis, osteoporosis, spinal stenosis, or deformity, a TDR leads to greater functional improvement and pain relief than fusion. In lumbar fusion, the use of a single cage or 2 cages results in equal rates of radiographic fusion. However, a single cage results in less intraoperative blood loss, shorter operating time, and fewer complications. | ||
Strong evidence | Evidence statement | Design |
Disc replacement is not inferior to fusion at 24 months for relief of back pain, reduction of disability, and provision of patient satisfaction. | Meta analysis | |
In the setting of lumbar interbody fusion, the use of a single cage achieves equal radiographic fusion as the use of 2 cages, with less intraoperative blood loss, shorter operating time, and fewer complications. | Systematic review | |
Good evidence | Evidence statement | Design |
Reoperation rates are higher with the use of interspinous spacers than with laminectomy or laminotomy in the setting of symptomatic lumbar spinal stenosis, but reoperation rates are not different between spacers and fusion operations. | Systematic review | |
In the setting of symptomatic degenerative lumbar disease from a variety of causes, motion-preserving devices, such as interspinous spacers or TDRs, can be expected to lead to pain relief and disability improvement comparable to the improvements seen with fusion surgery. | Systematic review | |
TDR is more likely than fusion to lead to long term complete pain relief in patients who have painful degenerative disc disease, no facet arthritis, spondylolysis or spondylolisthesis, osteoporosis, spinal stenosis, or deformity. TDR also leads on average to greater improvement in the ODI than fusion over 5 years. Both fusion and TDR lead to lasting symptomatic and functional benefits over 5 years in carefully selected patients. | RCT | |
An artificial disc is non-inferior to allograft fusion with a cage for single level disease. | Systematic review | |
Some evidence | Evidence statement | Design |
Pain and disability outcomes at 2 years are similar for 2-level lumbar degenerative disc disease between hybrid operations involving stand-alone anterior lumbar interbody fusion (ALIF) at L4-5 plus disc replacement at L5-S1, compared to non-hybrid operations involving interbody fusion at both levels or TDR at both levels. | Meta analysis | |
Some evidence cont. | In the setting of stable spinal stenosis with Grade I spondylolisthesis, decompression combined with a Coflex interlaminar stabilization device achieves similar clinical benefits as decompression combined with instrumented posterolateral fusion. | RCT |
In patients with symptomatic spinal stenosis at L4-5, posterior stabilization with Dynesys leads to greater motion preservation at the operated segment, and a reduced amount of excess movement at adjacent levels, than does posterior lumbar interbody fusion (PLIF) at 3 years postoperatively. | RCT | |
Dynesys and PLIF lead to comparable improvements in leg pain, back pain, and ODI scores at 3 years. | RCT | |
Dynesys requires shorter operative time, shorter hospital stays, and less blood loss than PLIF. | RCT | |
A 2-level lumbar disc replacement is not inferior to circumferential fusion in patients with 2 level degenerative disc disease and less than grade I spondylolisthesis 24 months after surgery. | RCT | |
A trial comparing TDR with circumferential fusion found superior function with lumbar disc replacement compared to fusion. However, the use of narcotics remained high even 2 years after a successful operation. | RCT | |
Table 67. Evidence Table: Lumbar Fusion and Adjacent Segment Degeneration | ||
Summary: Lumbar surgery with motion-preserving devices reduces the incidence of adjacent level disease and reoperation within 2-6 years. | ||
Good evidence | Evidence statement | Design |
Over a period of 2 to 6 years, surgery with motion-preserving devices in the lumbar spine is likely to lead to a lower incidence of adjacent segment disease and to require fewer reoperations than spinal fusion. | Systematic review | |
Some evidence | Evidence statement | Design |
In the setting of lumbar fusion, the risk of reoperation for adjacent segment disease is likely to be increased when there is a diagnosis of degenerative scoliosis and when the fusion extends from L4 to S1. | Review | |
TDR of the lumbar spine reduces the 5-year risk of adjacent level degeneration compared to circumferential fusion. | RCT | |
Table 68. Evidence Table: Lumbar Fusion Graft Site and Other Issues | ||
Strong evidence | Evidence statement | Design |
In the setting of lumbar spinal fusion, the use of bone morphogenetic protein (BMP) is associated with lower rates of reoperation over the following 2 years as compared to iliac crest bone graft. | Systematic review | |
Good evidence | Evidence statement | Design |
rhBMP-2 has a greater influence on promoting radiographic fusion in smokers than in nonsmokers when compared to iliac crest bone graft. | Meta analysis | |
rhBMP-2 promotes fusion better than iliac crest bone graft in normal weight and overweight patients, but rhBMP-2 may not influence fusion rates in obese and severely obese patients. | Meta analysis | |
Some evidence | Evidence statement | Design |
When instrumented single-level fusion is done for lumbar spondylolisthesis, local bone graft requires less operative time, yields equal rates of fusion and clinical improvement, and avoids persistent local symptoms at the iliac crest graft donor site. | RCT | |
Table 69. Evidence Table: Lumbar Fusion - Other Technical Issues | ||
Good evidence | Evidence statement | Design |
In the setting of spine fusion surgery, the use of antifibrinolytics such as tranexamic acid reduces intraoperative blood loss and total blood loss, leading to lower transfusion requirements, while not being accompanied with significant adverse effects compared to no antifibrinolytic use. | Systematic review | |
In the setting of transforaminal lumbar interbody fusion (TLIF), fusion rates are slightly lower with unilateral than with bilateral pedicle screw fixation. | Systematic review | |
In the setting of TLIF, cage migration occurs more commonly with unilateral than with bilateral pedicle screw fixation, and device-related complication rates also are likely to be higher. | Systematic review | |
In the setting of TLIF, there is less blood loss with unilateral than with bilateral pedicle screw fixation, and operative times are also shorter. | Systematic review | |
In the setting of TLIF, pain and functional outcomes are similar between unilateral and bilateral pedicle screw fixation; it is possible that the lower fusion rates and higher rates of cage migration with unilateral fixation are offset by less soft tissue dissection, shorter operative times, and less blood loss with unilateral fixation. | Systematic review | |
Some evidence | Evidence statement | Design |
In the setting of posterior spinal fusion using posterior iliac crest bone graft, the application of a sponge soaked in 0.25% bupivacaine at the time of bone harvest may reduce donor site pain for the first several months after surgery, compared to a sponge soaked in saline. | RCT | |
In patients undergoing posterior lumbar surgery for stenosis or spondylolisthesis, a loading dose of 30mg/kg tranexamic acid over 15 minutes and a maintenance infusion of 2 mg/kg/hour, was found to reduce perioperative blood loss as compared to a placebo. | RCT | |
In the setting of instrumented posterolateral fusion of the lumbar spine for degenerative spondylolisthesis, the addition of autologous bone marrow concentrate to allograft can be expected to significantly increase the rate of radiographic fusion 2 years after the operation is done. | RCT | |
Table 70. Evidence Table: Perioperative Medication Use in Fusion | ||
Summary: For patients undergoing spinal fusion surgery, preoperative analgesia may reduce postoperative pain and opioid use. Postoperative non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of nonunion at higher doses. | ||
Good evidence | Evidence statement | Design |
In the setting of lumbar spinal fusion, NSAIDs at an equivalence of no more than 120 mg of ketorolac for 14 days postoperatively do not appear to increase the risk of nonunion of the operated spinal segment. | Systematic review | |
Some evidence | Evidence statement | Design |
In the setting of PLIF surgery, a single saline infusion of 800 mg of ibuprofen one half hour prior to surgery may lead to less pain and morphine use in the immediate postoperative period and may thereby be an option for preoperative care of the surgical patient. | RCT | |
In the setting of 1-level or 2-level spinal fusion surgery, the administration of preemptive analgesia 8 hours preoperatively with acetaminophen, ketorolac, and pregabalin may confer benefits in the 48 hours following the procedure in the form of less pain, better ambulation, and less morphine use. | RCT | |
Some evidence cont. | Among patients undergoing posterior lumbar spinal fusion, the addition of preemptive analgesia using a single intravenous dose of ketorolac (30 mg) or parecoxib (40 mg) resulted in better immediate postoperative pain control as compared to a control (saline) group. However, the difference among the groups did not persist in measures from one-hour post-operatively up to 24 hours. There was no apparent opioid-sparing effect with preemptive analgesia. | RCT |
The preoperative administration of gabapentin in doses as low as 300 mg may reduce postoperative pain and opioid consumption in the setting of spinal laminectomy and fusion. The incidence of many postoperative complications such as nausea, headache, and dizziness is probably similar for gabapentin and placebo. Gabapentin may increase somnolence but may decrease the incidence of urinary retention pruritus. | Systematic review | |
In the setting of lumbar fusion without rhBMP-2, postoperative NSAIDs with an equivalent dose of more than 300 mg of diclofenac are associated with an increased risk of nonunion of the operated spinal segment. There appears to be a dose-dependent effect of postoperative NSAIDs on the risk of nonunion. | Systematic review | |
Table 71. Evidence Table: Post-operative Rehabilitation | ||
Some evidence | Evidence statement | Design |
It is appropriate to defer active rehabilitation for 12 weeks after instrumented fusion, as the group beginning 12 weeks postoperatively had greater improvements in disability compared to the 6 week group. | RCT | |
Introduction. Lumbar total disc replacement (TDR) is a surgical procedure where a degenerated disc is replaced with a prosthetic device. The endplates are positioned under intraoperative fluoroscopic guidance for optimal placement in the sagittal and frontal planes. The prosthetic device physiologically distributes the mechanical load of the vertebrae and maintains ROM.
Contraindications / Complications / Side Effects and Adverse Events.
Absolute and Relative Contraindications to Lumbar TDR.
* Absolute and relative contraindications include:
* significant spinal deformity and scoliosis;
* symptomatic facet joint arthrosis;
* spinal instability at the pathologic or adjacent level requiring fusion;
* deficient posterior elements;
* infection;
* any contraindication to an anterior abdominal approach, including multiple prior abdominal procedures;
* previous compression or burst fracture;
* spinal canal stenosis;
* spondylolysis;
* spondylolisthesis > 3 mm;
* osteopenia, osteoporosis, or any metabolic bone disease;
* chronic steroid or other medication use that interferes with bone or soft tissue healing;
* allergy to device materials;
* pregnancy or desire to become pregnant;
* extreme obesity (e.g., BMI > 40 kg/m2 or over 100 pounds overweight);
* active malignancy; and
* generalized chronic pain.
Complications of Lumbar TDR.
* Complications include nerve and vascular injury, dural tears, retrograde ejaculation, malpositioning/suboptimal positioning of prosthesis, implant failure, complex regional pain syndrome, complications from abdominal surgery (e.g., hernia or adhesions), and need for reoperation.
Recommendations.
Core Requirements.
Recommendation 159. Psychological evaluation is required to assess suitability for lumbar disc replacement. Documentation should include the following items with associated treatment recommendations:
* psychological factors that might influence elective surgical treatment outcomes, or
* psychological factors that might complicate surgical recovery.
Confounding depression or anxiety must be addressed prior to proceeding with surgery. Presurgical psychological evaluation should not be done by a psychologist employed by the physician performing the procedure. See the Behavioral and Psychological Interventions section.
Recommendation 160. Lumbar TDR is reserved for patients who meet all of the following criteria:
* symptomatic 1- or 2-level disc disease established by objective testing (e.g., CT scan or MRI followed by provocation discography),
* symptoms unrelieved after 6 months of active nonsurgical treatment,
* all pain generators are adequately defined and treated,
* all physical medicine and manual therapy interventions are completed,
* imaging studies demonstrate disc pathology requiring decompression, and
* psychosocial evaluation as outlined in recommendation 159, with confounding issues addressed (tables 72, 73, 74, 75).
Recommendation 161. If there are signs suggestive of facet-mediated pain, the pain must be evaluated with medial branch blocks before proceeding with disc replacement.
Recommendation 162. A trial of multi-disciplinary therapy must occur prior to proceeding with surgery (table 73).
Recommendation 163. Surgeons performing total disc arthroplasty must be trained in anterior spinal techniques and lumbar disc arthroplasty, and they must have attended lumbar arthroplasty training courses or undergone lumbar arthroplasty training in fellowship. It is highly recommended that the surgeon is mentored and proctored, and it is required that they have an assistant surgeon with anterior access experience.
Evidence Tables.
Table 72. Evidence Table: Degenerative Imaging Findings and Lumbar Disc Replacement | ||
Some evidence | Evidence statement | Design |
In patients with chronic non-radicular low back pain electing for lumbar disc prosthesis surgery, degenerative MRI findings may not be related to associated pain and disability. | Cross sectional | |
Table 73. Evidence Table: Total Disc Arthroplasty Versus Conservative Care | ||
Summary: Both TDR and multidisciplinary therapy may improve function. | ||
Some evidence | Evidence statement | Design |
Disc replacement has a slight advantage over intensive multidisciplinary treatment - 60 hours over 5 weeks. | RCT | |
In patients with symptomatic degenerative disc disease at L4-5 or at L5-S1 lasting more than 1 year, persisting after 6 months of physical therapy or chiropractic treatment, an initial treatment regimen consisting of rehabilitation with a multidisciplinary team of specialists may effectively improve function, defined as a 15 point improvement in the ODI, in up to half of patients, making it a reasonable initial treatment option. However, a TDR is overall more effective than multidisciplinary rehabilitation for pain and function, and may improve function by the same amount in about 70% of patients. | RCT | |
Table 74. Evidence Table: Total Disc Arthroplasty Versus Spinal Fusion | ||
Summary: TDR, fusion surgery, and the use of interspinous spacers result in similar improvements in function and pain. TDR results in a greater segmental ROM after 1-2 years compared with fusion. TDR leads to greater functional improvement and pain relief than fusion for patients with painful degenerative disc disease and without facet arthritis, spondylolysis, spondylolisthesis, osteoporosis, spinal stenosis, or deformity. | ||
Strong evidence | Evidence statement | Design |
Disc replacement is not inferior to fusion at 24 months for relief of back pain, reduction of disability, and provision of patient satisfaction. | Meta analysis | |
Good evidence | Evidence statement | Design |
An artificial disc is non-inferior to allograft fusion with a cage for single level disease. | Systematic review | |
There is greater segmental ROM after 1-2 years with arthroplasty as compared with fusion. | Meta analysis | |
Good evidence cont. | TDR is more likely than fusion to lead to long term complete pain relief in patients who have painful degenerative disc disease, no facet arthritis, spondylosis or spondylolisthesis, osteoporosis, spinal stenosis, or deformity. TDR also leads on average to greater improvement in the ODI than fusion over 5 years. Both fusion and TDR lead to lasting symptomatic and functional benefits over 5 years in carefully selected patients. | RCT |
In the setting of symptomatic degenerative lumbar disease from a variety of causes, motion-preserving devices such as interspinous spacers or TDRs can be expected to lead to pain relief and disability improvement comparable to the improvements seen with fusion surgery. | Systematic review | |
Some evidence | Evidence statement | Design |
A 2-level lumbar disc replacement is not inferior to circumferential fusion in patients with 2 level degenerative disc disease and less than grade I spondylolisthesis 24 months after surgery. | RCT | |
A trial comparing TDR with circumferential fusion found superior function with lumbar disc replacement compared to fusion. However, the use of narcotics remained high even 2 years after a successful operation. | RCT | |
An artificial disc is non-inferior to circumferential fusion with iliac crest autograft for single level disease. | Systematic review | |
Pain and disability outcomes at 2 years are similar for 2-level lumbar degenerative disc disease between hybrid operations involving stand-alone ALIF at L4-5 plus disc replacement at L5-S1, compared to non-hybrid operations involving interbody fusion at both levels or TDR at both levels. | Meta analysis | |
Table 75. Evidence Table: Adjacent Segment Degeneration and Lumbar TDR | ||
Summary: Lumbar surgery with motion-preserving devices reduces the incidence of adjacent level disease and reoperation within 2-6 years. | ||
Good evidence | Evidence statement | Design |
Over a period of 2 to 6 years, surgery with motion-preservation devices in the lumbar spine is likely to lead to a lower incidence of adjacent segment disease and to require fewer reoperations than spinal fusion. | Systematic review | |
Some evidence | Evidence statement | Design |
TDR of the lumbar spine reduces the 5-year risk of adjacent level degeneration compared to circumferential fusion. | RCT | |
Introduction. Interspinous process decompression theoretically relieves narrowing of the spinal canal and neural foramen in extension, thereby reducing the symptoms of neurogenic intermittent claudication, secondary to lumbar spinal stenosis.
Contraindications / Complications / Side Effects and Adverse Events.
Absolute and Relative Contraindications to Lumbar Interspinous Spacers.
* Absolute and relative contraindications include:
* anatomy that prevents implantation due to significant lumbar instability, ankylosis, acute fracture of the spinous process or pars interarticularis;
* allergy to titanium or titanium alloy;
* significant scoliosis;
* fixed motor deficit;
* cauda equina syndrome;
* neural compression causing neurogenic bowel or bladder dysfunction;
* previous lumbar surgery at the proposed spacer level;
* significant peripheral neuropathy;
* anterolisthesis greater than 1.0 (on a scale from 1-4) at the affected level;
* sustained pathological fractures;
* severe osteoporosis of the vertebrae or hips;
* severe foraminal stenosis;
* extreme obesity;
* active infection or systemic disease;
* Paget's disease or metastasis to the vertebrae;
* steroid use for more than 1 month within 12 months preceding surgery; and
* adjacent level disease is a relative contraindication.
Complications of Lumbar Interspinous Spacers.
* Complications include symptomatic spinous process fractures, new radicular defects, recurrent back pain, device extrusion or malposition, device failure with need for further surgery, infection, hematoma, and bilateral foot drop.
Recommendations.
Core Requirements.
Recommendation 164. Psychological evaluation is required to assess suitability for lumbar interspinous spacers. Documentation should include the following items with associated treatment recommendations:
* psychological factors that might influence elective surgical treatment outcomes, or
* psychological factors that might complicate surgical recovery.
Confounding depression or anxiety must be addressed prior to proceeding with surgery. Presurgical psychological evaluation should not be done by a psychologist employed by the physician performing the procedure. See the Behavioral and Psychological Interventions section (table 76).
Recommendation 165. Interspinous spacers are indicated for patients 50 years or older with intermittent neurogenic claudication caused by lumbar spinal stenosis who meet all of the following criteria:
* all pain generators are adequately defined and treated;
* all physical medicine and manual therapy interventions are completed over 6 months;
* impaired physical function is correlated with physical findings;
* CT or MRI demonstrates stenosis (e.g., evidence of thickened ligamentum flavum, narrowed lateral recess and/or central canal narrowing);
* spine pathology is limited to 1 or 2 levels;
* psychological evaluation as discussed in recommendation 164;
* ability to sit for 50 minutes without pain;
* ability to walk up to 50 feet or more; and
* relief in flexion from symptoms of leg/buttock/groin pain, with or without back pain (table 77).
Evidence Tables.
Table 76. Evidence Table: Factors Influencing Surgical Outcomes | ||
Summary: Patients undergoing spinal surgery who have perioperative depression may have poorer functional outcomes than those without depression. | ||
Some evidence | Evidence statement | Design |
Depression at the time of surgery and in the early recovery period is associated with poorer functional recovery at 2 years, even though it does not appear to be associated with worse pain at 2 years. | Cohort study | |
Depression at the time of operation and in the early postoperative period predicts poorer functional recovery from lumbar spinal stenosis surgery. | Cohort study | |
Table 77. Evidence Table: Lumbar Interspinous Spacers | ||
Some evidence | Evidence statement | Design |
An interspinous spacer device is superior to continuing nonoperative treatment after 6 months of conservative care has not resolved neurogenic claudication. | RCT | |
Introduction. Minimally invasive sacroiliac (SI) joint fusion is performed from a lateral approach under fluoroscopic guidance. The gluteus muscle is bluntly dissected and a pin is inserted across the SI joint so that a cannulated drill and broach can create a triangular wedge-shaped cavity in the ilium and sacrum through which titanium implants (typically 2-4) are inserted. The therapeutic goal of minimally invasive SI joint fusion is to provide stabilization and minimize micromotion/rotation of the instrumented SI joint. Open SI joint fusion for acute traumatic pelvic disruption is not discussed in these guidelines.
Contraindications / Complications / Side Effects and Adverse Events.
Relative and Absolute Contraindications to Minimally Invasive SI Joint Fusion.
* A contradiction to minimally invasive SI joint fusion is acute, traumatic instability of the SI joint due to trauma.
* Generalized pain behavior (e.g., somatoform disorder and presence of Waddell's signs) is an absolute contraindication.
* Systemic inflammatory arthropathies are a contraindication.
* Generalized pain syndromes (e.g., fibromyalgia) are relative contraindications.
Complications of Minimally Invasive SI Joint Fusion Requiring Surgical Revision.
* Complications of minimally invasive SI joint fusion that require surgical revision include symptomatic malposition, symptom recurrence, postoperative hematoma, device loosening, sacral nerve root impingement, suboptimal device positioning, iliac fracture, iliac vessel injury, and postoperative radicular pain.
* Long-term complication rates are unknown.
Complications and Adverse Events Related to Minimally Invasive SI Joint Fusion.
* Complications and adverse events include infection, wound healing issues, nerve damage, recurrent pain, urinary tract infection, bursitis, and postoperative issues.
* Long-term complication rates are unknown.
Recommendations.
Core Requirements.
Recommendation 166. Minimally invasive SI joint fusion is not recommended in the acute or subacute period.
Recommendation 167. Prior authorization is required before surgery. The requesting provider should document how the patient satisfies the clinical indications outlined in this section.
Recommendation 168. Psychological evaluation is required to assess suitability for minimally invasive SI joint fusion. Documentation should include the following items with associated treatment recommendations:
* psychological factors that might influence elective surgical treatment outcomes, or
* psychological factors that might complicate surgical recovery.
Confounding depression or anxiety must be addressed prior to proceeding with surgery. Presurgical psychological evaluation should not be done by a psychologist employed by the physician performing the procedure. See the Behavioral and Psychological Interventions section.
Recommendation 169. Minimally invasive SI joint fusion should be reserved for patients who meet all of the following indications:
* at least 6 months of persistent functional impairment and pain, unresponsive to intensive conservative therapies, including medication, manual therapy, active therapeutic exercise (e.g., optimizing lumbosacral and pelvic ROM and identification/treatment of muscular imbalance);
* patient localization of typically unilateral symptoms as indicated by Fortin finger test with reported pain at the posterior superior iliac spine;
* physical examination findings consistent with SI joint origin pain, including 3 positive physical exam maneuvers (e.g., compression test, thigh thrust test, sacral thrust test, Patrick's, Gaenslen test, distraction test, Gillett test);
* imaging studies (e.g., CT or MRI) of the lumbar spine, and where clinically indicated, of the hip, and/or pelvis that fail to reveal other sources that might better explain the symptoms (e.g., inflammatory arthropathy, evidence of neural compression, facet disease, disc disease, degenerative labral tears, tumor, infection, fracture); and
* psychological evaluation as outlined in recommendation 168 (see the Behavioral and Psychological Interventions section); and
* positive response to initial and confirmatory fluoroscopically-guided SI joint local anesthetic blocks with arthrogram confirming needle placement in the SI joint, consisting of:
* documented improvement in previously impaired SI joint function and provocative physical examination maneuvers within expected time frame of local anesthetic (e.g., spinal ROM; tolerance and time limits for sitting, standing, walking, and lifting; Patrick's sign; Gaenslen; distraction; gapping and compression tests); and
* 80% improvement in accepted pain scales (e.g., VAS or NRS), consistent with:
* the expected duration of the injected local anesthetic phase, and
* a post-injection pain diary with at least 8 hourly response recordings, but preferably daily for 1 week (table 78).
Recommendation 170. The surgeon must have specific training and expertise in performing this procedure.
Recommendation 171. Systemic inflammatory arthropathies, including ankylosing spondylitis and rheumatoid arthritis, are not indications for minimally invasive SI joint fusion.
Recommendation 172. Tobacco cessation for at least 6 weeks prior to fusion is required, unless the surgeon documents reasoning that the benefits of proceeding with surgery outweigh the risks.
Recommendation 173. Imaging guidance is required to perform implant placement.
Recommendation 174. An individualized postoperative rehabilitation program is appropriate for patients at the discretion of the surgeon.
Evidence Tables.
Table 78. Evidence Table: Minimally Invasive SI Joint Fusion for Chronic SI Joint Pain | ||
Summary: For patients with chronic low back pain and a high likelihood of true SI joint pathology, surgical fusion with triangular titanium implants provides greater improvement in function and pain at 6 months than continued conservative treatment. These benefits may continue for at least 4 years after the operation. | ||
Good evidence | Evidence statement | Design |
In patients with chronic low back pain originating from the SI joint, a fusion procedure using triangular titanium implants leads to greater improvements in pain and function at 6 months than continued conservative treatment with optimum medical management and individualized physical therapy. | RCT | |
Some evidence | Evidence statement | Design |
In the setting of chronic SI joint pain, a surgical fusion procedure involving triangular titanium implants is likely to confer greater benefits in pain reduction and functional improvement than continued nonsurgical pain management with medications, steroid injection, and RF neural ablation, with benefits appearing to be maintained 2, 3, and 4 years after the operation. | RCT | |
Introduction. Kyphoplasty is a surgical procedure for the treatment of symptomatic thoracic or lumbar vertebral compression fractures and occasionally post-traumatic compression fractures and minor burst fractures that do not significantly compromise the posterior cortex of the vertebral body.
Kyphoplasty involves the percutaneous insertion of a trocar and inflatable balloon or expanding polymer into the vertebral body, which re-expands the body, elevating the endplates and reducing the compression deformity. Polymethylmethacrylate (PMMA) bone cement is injected under low pressure into the cavity created by balloon inflation.
Contraindications / Complications / Side Effects and Adverse Events.
Absolute and Relative Contraindications to Kyphoplasty.
* Absolute and relative contraindications include:
* asymptomatic vertebral body compression fracture;
* patient improvement with medical treatment;
* presence of neurologic compromise related to fracture;
* high-velocity fractures with a significant burst component;
* significant posterior vertebral body wall fracture;
* severe vertebral collapse (vertebra plana);
* infection; and
* uncorrectable coagulopathy.
Complications of Kyphoplasty.
* Complications include new vertebral compression fracture, cement leakage, infection and extravertebral extravasation of the bone cement, with rare serious complications such as cemental pulmonary embolism, radiculopathy, and paraplegia.
* Procedure-related deaths have been reported.
Recommendations.
Core Requirements.
Recommendation 175. Kyphoplasty may occur within the first 12 weeks of care after vertebral compression fracture when all of the following criteria are met:
* compression fracture with vertebral height loss between 15% and 85%,
* failure to respond to at least 4 weeks of conservative management, and
* functional impairment prevents performance of ADLs (table 79).
Evidence Table.
Table 79. Evidence Table: Kyphoplasty Versus Conservative Management for Compression Fractures | ||
Summary: Kyphoplasty results in rapid functional improvement in the first month after compression fracture as compared to non-operative treatment, but the difference between groups diminishes over time. | ||
Good evidence | Evidence statement | Design |
Kyphoplasty provides rapid improvement in function in the initial months after the fracture, as compared to non-operative treatment or analgesics alone. | RCT | |
Some evidence | Evidence statement | Design |
In the setting of osteoporitic vertebral compression fractures, the Kiva (trademarked vertebral augmentation system) coiled implant is noninferior to conventional balloon kyphoplasty in terms of pain relief, functional improvement, and safety at 1 year after the procedure is done. | RCT | |
Introduction. Vertebroplasty is a minimally invasive surgical procedure for the treatment of painful thoracolumbar vertebral compression fractures secondary to osteoporosis or other metabolic bone disease. In this procedure, bone cement is injected with high pressure into the vertebral body under constant fluoroscopic guidance. This guidance is used throughout the procedure to minimize cement leakage. Traditionally, a low-viscosity acrylic bone cement, PMMA, is used, but other types of bone cement such as high-viscosity PMMA, glass polymers, hydroxyapatite, and calcium phosphate are also commercially available. The procedure is usually performed under intravenous sedation or light general anesthesia. The goal of the procedure is to stabilize the spine and to relieve pain.
Contraindications / Complications / Side Effects and Adverse Events.
Absolute and Relative Contraindications to Vertebroplasty.
* Absolute and relative contraindications include:
* asymptomatic vertebral body compression fracture,
* patient improvement with conservative measures alone,
* presence of fracture-related neurologic compromise,
* high-velocity fractures with a significant burst component,
* posterior vertebral body wall fracture,
* severe vertebral collapse (vertebra plana),
* spinal canal stenosis,
* allergy to bone cement or opacification agents,
* infection, and
* uncorrectable coagulopathy.
Complications of Vertebroplasty.
* Procedure-related deaths have been reported.
* Complications include extravertebral extravasation of the bone cement, with rare serious complications such as cemental pulmonary embolism, radiculopathy and paraplegia.
* New vertebral compression fractures may occur following vertebroplasty.
Side Effects and Adverse Events Related to Vertebroplasty.
* Side effects and adverse events include localized pain at the site of the procedure.
Recommendations.
Core Requirements
Recommendation 176. Vertebroplasty may be considered for a select subgroup of patients with vertebral compression fractures within 4 and 12 weeks of pain onset when the following criteria have been met:
* compression fracture has been radiographically confirmed to cause pain and limit activity;
* symptoms are localized clinically to the level of the vertebral fracture;
* inability to perform ADLs;
* failure to respond to at least 4 weeks of conservative management;
* patient is healthy enough to undergo surgery, if necessary, for decompression;
* vertebral height loss between 15% and 85%; and
* an intact posterior wall (table 80).
Evidence Tables.
Table 80. Evidence Table: Vertebroplasty for Compression Fracture | ||
Summary: For patients with acute osteoporotic vertebral fractures and mild to moderate pain, vertebroplasty and sham vertebroplasty (infiltration of the periosteum with local anesthesia) have clinically equivalent effects on function and pain. Vertebroplasty results in greater improvement in function and pain than continued medical management and physical therapy. Sham vertebroplasty has not been compared with continued medical management. | ||
Strong evidence | Evidence statement | Design |
In the setting of acute osteoporotic vertebral compression fractures with mild to moderate pain, there are no clinically important differences between true and sham vertebroplasty for pain, function, or quality of life. The addition of PMMA cement does not enhance the therapeutic effects of a local anesthetic infiltration of the periosteum of the affected vertebra. Percutaneous vertebroplasty should not be a standard treatment for these fractures. | Systematic review | |
Good evidence | Evidence statement | Design |
Osteoporotic vertebral fractures improve equally with both vertebroplasty and with well-simulated sham vertebroplasty that includes infiltration of the periosteum with local anesthesia. This study has been criticized for selection bias due to the failure of most patients to be willing to enroll in a randomized trial. | RCT | |
Vertebroplasty does not differ from sham vertebroplasty in patients with acute (less than 6 months duration) osteoporotic vertebral fractures demonstrated by MRI criteria of edema and or/a fracture line, but that may apply only to patients whose pain is not severe enough to lead to hospitalization. This study has been criticized for selection bias due to the failure of most patients to be willing to enroll in a randomized trial. | RCT | |
In the setting of acute osteoporotic vertebral compression fractures, percutaneous vertebroplasty is associated with greater pain relief and disability improvement than continued medical management combined with physical therapy. It is uncertain whether this difference represents a placebo (expectation) effect for the procedure or whether it represents a therapeutic effect of the local anesthetic. The effect of an anesthetic infiltration of the periosteum of the affected vertebra has not been tested as a stand-alone treatment in any randomized trial published to date. | Systematic review | |
In patients with acute osteoporotic vertebral fractures accompanied by edema on MRI, a vertebroplasty procedure and a sham vertebroplasty procedure | RCT | |
yield rapid decreases in pain and disability that persist for up to 12 months. After a periosteal infiltration with a local anesthetic is done, the addition of a PMMA cement injection does not appear to add significant additional benefits. | ||
Vertebroplasty improves pain scores more rapidly than individualized pharmacological therapy for patients with acute osteoporotic vertebral fractures with effects detectable in the first day and persisting up to 1 year. | RCT | |
Some evidence | Evidence statement | Design |
In patients with severe pain (7 or more on a 0-10 scale) arising from acute osteoporotic vertebral compression fractures, treatment with vertebroplasty is more effective than sham vertebroplasty in reducing pain at 14 days post-procedure, and in patients hospitalized for osteoporotic vertebral compression fractures, vertebroplasty is likely to reduce the length of hospital stay. | RCT | |
Vertebroplasty is associated with earlier pain relief and functional mobility than pharmacologic treatment alone, but there may be a risk of new clinically significant vertebral fractures when more than 1 vertebra is treated. | RCT | |
Introduction. Spinal cord stimulation is the delivery of low-voltage electrical stimulation to the spinal cord or peripheral nerves to inhibit or block the sensation of pain. The system uses implanted electrical leads and a battery powered implanted pulse generator. See the Chronic Pain Disorder MTGs.
Recommendations.
Core Requirements.
Recommendation 177. Neurostimulation is reserved for patients who meet the criteria outlined in the Chronic Pain Disorder MTGs.
Evidence Tables. See the Chronic Pain Disorder MTGs for evidence.
Introduction. Epiduroscopy and epidural lysis of adhesions involves the introduction of a fiberoptic endoscope into the epidural space via the sacral hiatus. A saline irrigation is performed with or without epiduroscopy to distend the epidural space and result in lysis of adhesions.
Contraindications / Complications / Side Effects and Adverse Events.
Complications of Epiduroscopy.
* Saline irrigation on epiduroscopy and lysis of adhesions is associated with risks of elevated pressures that may impede blood flow and venous return, possibly causing ischemia of the cauda equina and retinal hemorrhage.
* Other epiduroscopy complications associated with instrumented lysis include catheter shearing, need for catheter surgical removal, infection (including meningitis), hematoma, and possible severe hemodynamic instability during application.
Recommendations.
Core Requirements.
Recommendation 178. Epiduroscopy and mechanical lysis of adhesions and epiduroscopy-directed steroid injections are not recommended.
Evidence Tables. None. The above recommendation was based on consensus.
7 CCR 1101-3-17-01-8