7 Colo. Code Regs. § 1101-3-17-08-8

Current through Register Vol. 47, No. 18, September 25, 2024
Section 7 CCR 1101-3-17-08-8 - Third Line Treatment, as Indicated
Section 8.a.Injections - Diagnostic and Therapeutic

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 neck 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.

Section 8.a.i.Epidural Steroid Injection (ESI) and Transforaminal Nerve Root Block

Introduction. Epidural steroid injections (ESIs) are corticosteroid injections into the cervical epidural space by a 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 ROM and facilitate progress in active therapy programs by temporarily reducing pain and inflammation in the acute or subacute phases of injury.

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.

* Significant spinal stenosis is a contraindication to an injection at that level. This applies to placing a needle at the spinal stenosis area, but it is acceptable to inject adjacent to the level.

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.

* Cervical epidural injections carry additional risks of injury including death, spinal cord injury, and stroke when compared to lumbar injections.

* Headache, nerve injury, transient neurapraxia, vasovagal effects, infection, local pain, epidural hematoma, spinal cord injury, dural perforation, and cerebrospinal fluid leaks have been reported.

* Direct needle trauma is a reported complication (recommendation 90).

* Although major neurological complications are rare with fluoroscopically-guided ESIs, there is a much greater risk with injections above C5-C6 and with particulate steroid injections (recommendation 91; table 28).

* 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.

* Dose-dependent suppression of the hypothalamic-pituitary-adrenal axis, leading to a transient secondary adrenal insufficiency in the first few weeks after ESI (table 27).

Recommendations.

Core Requirements.

Recommendation 87. Interlaminar injections should not be performed above the level of C6-C7 nor at the level of any stenosis as demonstrated on pre-procedure imaging review.

Recommendation 88. 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 neural compression test (e.g., dural tension, Spurling's sign, traction/distraction, upper limb tension test) and/or reflex, motor, or sensory changes on examination specifically correlating with imaging findings; and

* imaging findings that demonstrate impingement of nerve(s) or spinal cord.

Recommendation 89. ESI is not recommended for the treatment of axial neck pain in the absence of radicular symptoms.

Recommendation 90. Multi-planar fluoroscopic imaging is required to create permanent images confirming proper needle placement and contrast flow pattern.

Recommendation 91. Particulate corticosteroid preparations are not recommended for epidural injection (table 28).

Recommendation 92. 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 29).

Recommendation 93. 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 appear to be at risk for Type 2 diabetes (table 30).

Recommendation 94. 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; tolerance and time limits for reaching and lifting); and

* at least 80% radicular pain improvement as measured using an accepted pain scale (e.g., visual analog scale [VAS] or numeric rating scale [NRS]) that is consistent with:

o the expected duration of the injected local anesthetic phase, and

o a post-injection pain diary with at least 8 hourly response recordings and preferably for 1 week if local anesthetic is used. 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 95. Early referral within 6 weeks for ESI is permitted when the provider documents all criteria in recommendation 88 and at least 1 of the following:

* radicular pain-related functional impairment prevents participation in active therapy and activities of daily living (ADLs); or

* an opioid treatment is being considered.

Subacute and Chronic Phase Requirements (After 6 Weeks of Care).

Recommendation 96. ESI or referral for surgical consultation is permitted for patients who meet the criteria in recommendation 88 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 31).

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 reaching 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 27.

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 28.

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

Good 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

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

Table 29.

Evidence Table: Use of Steroid in Epidural Injections

Summary:

The addition of a corticosteroid may not provide added improvement in function or pain over epidural injections with local anesthetic or saline 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.

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

Results from transforaminal injections of anesthetic plus steroids is similar to injections with anesthetic only in the cervical spine.

RCT

Table 30.

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 31.

Evidence Table: Depression and Cervical ESI

Some evidence

Evidence statement

Design

Among patients with cervical radiculopathy who are considered to be surgical candidates, for whom a trial of non-surgical treatment is an option, the presence of clinical depression, defined as a score greater than 33 on the Zung Depression scale, is an unfavorable predictor for a successful response to a cervical ESI, reducing the favorable response rate by more than 50%.

Cohort study

Section 8.a.ii.Zygapophyseal (Facet) Injection

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 associated spinal nerve may result in associated weakness and numbness of that level.

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 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 are 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.

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. None. The above recommendations were based on consensus.

Section 8.a.iii. Intradiscal Injection

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 Injections.

* Complications include infection, pain, bleeding, nerve injury, and allergic reaction to contrast dye.

Recommendations.

Core Requirements.

Recommendation 105. Intradiscal injections are not recommended (table 32).

Evidence Tables.

Table 32.

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

Section 8.a.iv.Medial Branch Block and Radiofrequency (RF) Denervation

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 with repeat RF neurotomy.

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 106. Diagnostic medial branch blocks are recommended when all of the following are present:

* 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);

* 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 107. 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 108. 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; reaching 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:

o the expected duration of the injected local anesthetic phase, and

o 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.

Recommendation 109. 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 110. RF neurotomy is not recommended for patients with non-facetogenic pain generators or involvement of more than 3 levels of medial branch nerves per side.

Recommendation 111. RF neurotomy is only indicated for those with proven facetogenic joint pain who have met the criteria for a positive response to 2 controlled medial branch blocks, as defined in recommendation 108 (table 33). Intra-articular facet joint steroid injections are not considered diagnostic blocks for the purposes of this criteria.

Recommendation 112. Cooled RF denervation, pulsed RF, dorsal nerve root ganglion RF ablation, and transdiscal biacuplasty are not recommended for the cervical spine.

Repeat RF Neurotomy Requirements.

Recommendation 113. 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; reaching and lifting) and improvement in an accepted pain scale (e.g., VAS or NRS) after initial RF neurotomy (Appendix Functional Scales). Functional progress supersedes pain improvement. The potential for atrophy of the spinal musculature should be factored into clinical decision making.

Recommendation 114. If the patient's pain presents differently than the initial rhizotomy, a confirmatory medial branch block, as outlined in recommendation 108, will be necessary.

Evidence Tables.

Table 33.

Evidence Table: Cervical RF Neurotomy

Some evidence

Evidence statement

Design

RF neurotomy relieves pain and restores function in patients whose neck pain arises from the facet joint but benefits beyond 1 year are not yet established. This was determined by a methodologically carefully done study whose application as evidence is limited by the size of the patient sample.

RCT

Section 8.a.v.Prolotherapy

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 neck.

Contraindications / Complications / Side Effects and Adverse Events.

Side Effects and Adverse Events Related to Cervical Prolotherapy.

* Side effects and adverse events include a temporary increase in neck pain and stiffness post-injection.

Recommendations.

Core Requirements.

Recommendation 115. Prolotherapy is not recommended for neck pain.

Evidence Tables. None. The above recommendation was based on consensus.

Section 8.a.vi.Trigger Point Injection

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 is 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 116. 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.

Recommendation 117. Concurrent participation in a therapeutic exercise program is required while undergoing myofascial interventions. See the Active Therapies section.

Recommendation 118. 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 Tables. None. The above recommendations were based on consensus.

Section 8.a.vii.Botulinum Toxin Injection

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. See the Mild Traumatic Brain Injury MTGs for botulinum toxin injection use in the treatment of cervicogenic and migraine headaches.

Contraindications / Complications / Side Effects and Adverse Events.

Absolute Contraindications to Botulinum Toxin Injection.

Absolute contraindications to botulinum toxin injection include:

o hypersensitivity to any botulinum toxin preparation or any of the components in the formulation,

o infection at the proposed injection site, and

o motor neuropathy or neuromuscular junction disorders.

Complications of Botulinum Toxin Injection.

* Complications include 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 paracervical 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 (table 34).

Recommendations.

Core Requirements.

Recommendation 119. Botulinum trigger point injections are not recommended for nonspecific neck pain or myofascial trigger points (table 35).

Recommendation 120. Botulinum toxin injection may be used for centrally mediated spasticity, dystonia, or torticollis resulting in limited ROM.

Recommendation 121. After appropriate dose titration, repeat botulinum injections are only recommended when the first injection results in at least 80% improvement in an accepted pain scale (e.g., VAS or NRS) with associated improvement in currently impaired physical function. Functional progress supersedes pain improvement.

Time Frames.

Time Frames for Botulinum Toxin Injections

Time to produce effect

Duration between injections

Maximum duration

24 to 72 hours post-injection*

> 3 months**

Maximum 4 injections

*Peak effect by 4 to 6 weeks.

**Patient should be reassessed after each injection session.

Evidence Tables.

Table 34.

Evidence Table: Botulinum Adverse Events

Summary:

Botulinum toxin injections commonly lead to adverse effects.

Good evidence

Evidence statement

Design

Cervical botulinum toxin A injections cause transient dysphagia and neck weakness. Allergic reaction to medications, dry mouth, and vocal hoarseness may also occur. Dry mouth and dysphagia occur 15% of the time after 1 injection of botulinum toxin type B.

Meta analysis

Among those with cervical dystonia, treatment with botulinum toxin type A is more likely than placebo to lead to adverse effects such as local weakness and dysphagia.

Systematic review

In non-naive botulinum toxin populations, the occurrence of the specific adverse effect of "sore-throat/dry-mouth" was 36.2% higher in patients using botulinum toxin B as compared to patients using botulinum toxin A.

Systematic review

Table 35.

Evidence Table: Botulinum Injection Effectiveness

Summary:

For patients with cervical dystonia, botulinum toxin injections reduce dystonia and pain. They do not provide benefit for nonspecific cervical pain.

Table 35 continued.

Evidence Table: Botulinum Injection Effectiveness

Strong evidence

Evidence statement

Design

Botulinum toxin A has objective and symptomatic benefits over placebo for cervical dystonia.

Meta analysis

Good evidence

Evidence statement

Design

A single injection of botulinum toxin type B is more effective than placebo in alleviating the severity and pain of idiopathic cervical dystonia. The duration of effect of botulinum toxin type B is not certain but appears to be approximately 12 to 18 weeks.

Meta analysis

Botulinum toxin is not different from placebo for cervical pain.

Meta analysis

Section 8.b.Surgical Interventions

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 neck 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 122. Expedited surgical referral is required for patients with myelopathy, acute fracture, or dislocation or for patients with functional loss due to stenosis and instability and/or progressive neurologic deficits.

Recommendation 123. Surgical referral for patients with cervical radiculopathy is recommended when confirmatory imaging studies specifically correlate with clinical findings, demonstrating nerve root compression or spinal cord compromise and any of the following are present:

* acute, incapacitating pain with progressive neurologic deficits;

* persistent or recurrent arm pain with functional limitations unresponsive to 6 weeks of treatment;

* progressive neurologic deficits; or

* static neurologic deficit with significant radicular pain.

Recommendation 124. Surgical referral for patients with persistent non-radicular cervical pain is recommended when frequent symptom recurrence results in functional limitations even if non-operative treatment provides temporary relief and all of the following are present:

* non-operative treatment fails to result in consistent functional improvement;

* diagnostic elimination of confounding psychological or physical conditions that may respond to non-surgical techniques but may be refractory to surgical intervention; and

* symptomatic improvement has plateaued and residual functional disability is unacceptable at 6 months.

Recommendation 125. Continuation of exercise and/or active therapy while awaiting a surgical evaluation or surgical procedure is recommended to maintain and optimize physical conditioning.

Recommendation 126. Informed consent is required before all invasive procedures. See the Essential First Line Treatment section.

Recommendation 127. Participation in a postoperative active therapy program that includes core stabilization, strengthening, and endurance is strongly recommended. See the Active Therapies section.

Recommendation 128. Diabetes control and related routine lab work, including hemoglobin A1c, are recommended prior to surgery.

Recommendation 129. 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 the Active Therapies section);

* use of non-opioid medication strategies as adjunct to anesthesia and pre- or postoperative pain management (see the Medications section);

* use of peripheral regional analgesia; and/or

* use of passive therapy for postoperative pain (see the Passive Therapies section).

Recommendation 130. Intraoperative neuromonitoring is permitted to evaluate spinal cord integrity and screw placement during the operative procedure.

Recommendation 131. Percutaneous RF disc decompression and intradiscal electrothermal therapy are not recommended.

Evidence Tables. None. The above recommendations were based on consensus.

Section 8.b.i. Discectomy

Introduction. Discectomy is a surgical treatment for ruptured or herniated discs of the cervical spine. There are several procedures in use to decompress extruded disc material around nerve roots, including several minimally invasive techniques. Cervical discectomy is typically paired with fusion. Please see the Spinal Fusion section for additional information. This includes:

* microscopic discectomy,

* percutaneous discectomy,

* microdiscectomy, and

* laser discectomy.

Contraindications / Complications / Side Effects and Adverse Events.

Complications of Cervical Discectomy.

* Complications of discectomy include nerve damage, spinal fluid leakage, esophageal injury, infection, vascular injury, and hemorrhage.

* Complications of percutaneous discectomy include nerve or vessel injury, infection, hematoma, and incomplete nerve root dissection.

Recommendations.

Core Requirements.

Recommendation 132. 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 133. For a patient to be a candidate for an isolated cervical discectomy, the provider must document all of the following:

* subjective report of severe radicular pain;

* positive neural compression test (e.g., dural tension, Spurling's sign, traction/distraction, upper limb tension 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.

Recommendation 134. 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 95.

Recommendation 135. The decision to proceed with an open or minimally invasive technique for cervical discectomy is left to the treating surgeon's discretion, experience, and training in these techniques (table 36).

Acute Phase Requirements (Within 6 Weeks of Initial Care).

Recommendation 136. Early referral within 6 weeks for isolated cervical discectomy is permitted when the provider documents all criteria in recommendations 132 and 133 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 137. Referral for isolated cervical discectomy is permitted for patients who meet the criteria in recommendation 133 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 138. Laser discectomy and percutaneous discectomy are not recommended.

Evidence Table.

Table 36.

Evidence Table: Effectiveness of Cervical Discectomy

Some evidence

Evidence statement

Design

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

Section 8.b.ii.Decompression for Central or Lateral Spinal Stenosis

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,

* corpectomy,

* discectomy, and

* laminoplasty.

Contraindications / Complications / Side Effects and Adverse Events.

Absolute and Relative Contraindications to Decompressive Surgery.

* Unaddressed depression or cardiovascular comorbidity are relative contraindications.

* Documented radiographic instability is a contraindication for decompression alone.

* Scoliosis is a relative contraindication to decompression.

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, kyphosis, and incomplete decompression.

Recommendations.

Core Requirements.

Recommendation 139. A psychological screen with a follow-up psychological evaluation, if indicated, is required prior to proceeding with decompression. If the surgery is being performed in an emergent or urgent situation, the screen is not necessary.

Recommendation 140. 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.

Recommendation 141. Cervical laminoplasty or laminectomy alone is recommended for patients with spinal stenosis or spondylotic myelopathy primarily related to posterior spinal compressive pathology in the absence of kyphosis.

Recommendation 142. Corpectomy or hemicorporectomy with fusion is recommended for patients with 1- or 2- level spinal stenosis, spondylolisthesis, or severe kyphosis and associated spinal cord compression.

Evidence Tables. None. The above recommendations were based on consensus.

Section 8.b.iii. Spinal Fusion

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.

Contraindications / Complications / Side Effects and Adverse Events.

Absolute and Relative Contraindications to Cervical Fusion.

Morbid obesity is a relative contraindication to fusion (table 37).

Complications of Cervical Fusion.

Complications include instrumentation failure, pseudoarthrosis, superficial or deep wound infection, incomplete decompression, in-hospital mortality, bone graft donor site pain graft extrusion, cerebrospinal fluid leak, laryngeal nerve damage, iatrogenic kyphosis, dysphonia, dysphagia, esophageal perforation, airway obstruction, and acceleration of adjacent segment disease (table 37).

Recommendations.

Core Requirements.

Recommendation 143. Cervical fusion is not recommended in the first 6 months of symptoms, except for acute fracture, dislocation, or for some patients with functional loss due to stenosis and instability, myelopathy, and/or progressive neurologic deficits.

Recommendation 144. Psychological evaluation is required to assess suitability for a cervical 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 38).

Recommendation 145. Spinal fusion is reserved for patients who meet either of the following sets of criteria:

either

* cervical radiculopathy resulting in incapacitating pain; and

* imaging studies (e.g., MRI) consistent with clinical findings, demonstrating nerve root or spinal cord compromise; and

* one of the following:

o progressive functional neurological deficit; or

o persistent motor deficit; or

o persistent or recurrent arm pain with functional limitations, unresponsive to conservative treatment after 6 weeks; or

o static neurological deficit associated with significant radicular pain.

or

* persistent non-radicular cervical pain unrelieved by non-operative treatment; and

* all pain generators are adequately defined and treated; and

* all physical medicine and manual therapy interventions are completed; and

* imaging studies demonstrate spinal stenosis with instability or disc pathology, requiring decompression; and

* psychological evaluation, with confounding issues addressed as discussed in recommendation 144; and

* one of the following:

o improvement of symptoms has plateaued and the residual symptoms of pain and signs of functional disability are unacceptable at the end of 6 months of active treatment; or

o frequent symptom recurrence causes serious functional limitations even if a non-operative active treatment program provides satisfactory symptom relief and functional restoration at each occurrence (tables 39, 40).

Recommendation 146. In the absence of radiculopathy, fusion is limited to 2 spinal levels.

Recommendation 147. Discography is not recommended for use in evaluating cervical spine conditions.

Recommendation 148. 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 149. Cervical application of recombinant human bone morphogenetic protein (rhBMP) is not recommended (table 37).

Recommendation 150. The choice of bone graft donor site, grafting substance, operative technique, and surgical approach are at the discretion of the treating surgeon (tables 41, 42).

Recommendation 151. Strategic perioperative medication use is recommended for pain management to minimize opioid use and optimize surgical outcome.

Recommendation 152. Postoperative participation in an active therapy program that includes core stabilization, strengthening, and endurance is recommended. See the Active Therapies section.

Recommendation 153. Cervical bracing is permitted following fusion.

Evidence Tables.

Table 37.

Evidence Table: Complications Related to Cervical Fusion

Good evidence

Evidence statement

Design

Recombinant human bone morphogenetic protein-2 (rhBMP-2) increases the risks of dysphagia, dysphonia, and other postoperative complications in the setting of anterior cervical fusion, but there is uncertainty regarding the risks of cancer associated with the use of bone morphogenetic protein (BMP) in spine fusion of any type and uncertainty about the comparative risks of retrograde ejaculation sometimes attributed to BMP.

Meta analysis

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 38.

Evidence Table: Factors Influencing Surgical Outcomes

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

Table 39.

Evidence Table: Anterior Cervical Discectomy and Fusion (ACDF)

Strong evidence

Evidence statement

Design

Outpatient anterior cervical discectomy and fusion (ACDF) and inpatient ACDF both have low postoperative complication rates, and there is no difference in risks of commonly occurring complications for the procedure between the 2 settings, but there is insufficient evidence to compare the safety of the 2 settings for rare but potentially catastrophic events.

Meta analysis

Good evidence

Evidence statement

Design

In the setting of symptomatic cervical radiculopathy from herniated discs and/or osteophytes at 1 or 2 levels, it is reasonable to initiate a program of structured physical therapy before any surgical decisions are made, since many patients will experience significant improvement in pain and function. However, a program of ACDF plus structured physical therapy is likely to be superior to physical therapy alone, and the improvements appear to continue for at least 5 to 8 years.

RCT

Table 40.

Evidence Table: ACDF Versus Total Disc Arthroplasty

Summary:

Both cervical disc arthroplasty (CDA) and ACDF are safe and effective interventions for patients with cervical degenerative disc disease. CDA leads to greater improvements in pain and disability and fewer reoperations than ACDF.

Strong evidence

Evidence statement

Design

For patients with cervical degenerative disc disease at 1 or 2 levels, both CDA and ACDF are safe and effective interventions leading to symptomatic relief and functional improvement.

Meta analysis

In patients with single level radiculopathy or myelopathy, cervical artificial disc produces 2-year success rates at least equal to those of ACDF with allograft interbody fusion and an anterior plate.

Meta analysis

For patients with single-level cervical degenerative disc disease, there is strong evidence that both CDA and ACDF are safe and effective interventions leading to symptomatic relief and functional improvement.

Systematic review

Good evidence

Evidence statement

Design

Overall success, ascertained by improvement in neck disability scores combined with favorable neurological outcome and no repeat surgery at the operated level, is better with CDA than with ACDF.

Meta analysis

In patients with stable 1 or 2 level cervical disc disease who have minimal facet joint degeneration and bone mineral density greater than a T-score of -1.5, and who do not have axial neck pain as the sole presenting symptom, treatment with either total disc replacement (TDR) or ACDF are likely to alleviate pain and disability for at least 7 years, and that the TDR procedure is likely to confer greater benefit than fusion. Reoperation rates may be lower with disc replacement but this inference must be made with considerable caution.

RCT

CDA leads to slightly better outcomes than ACDF for improvements in neck and arm pain and cervical spine function.

Systematic review

CDA is associated with fewer repeat operations at adjacent spine levels than ACDF for the first several years after the surgery is performed.

Systematic review

In the setting of radiographically stable cervical degenerative disc disease from C3 to C7 at 2 adjacent levels, CDA is at least as safe and effective as fusion with an anterior plate and a ring allograft, and is likely to require fewer reoperations in the first 2 years after surgery.

RCT

Some evidence

In patients with single-level cervical radiculopathy, without signs of myelopathy and with preservation of at least 3mm of disc height, equally good improvements in neck disability are expected after 2 years with any of 3 operations: anterior cervical discectomy alone, anterior cervical discectomy with fusion and a polyetheretherketone (PEEK) cage, or anterior CDA.

Evidence is lacking to suggest that the development of adjacent segment degeneration is significantly different after 2 years with 1 or another of these 3 surgical options.

RCT

Cervical TDR requires fewer revision operations than ACDF after the first 2 years of treatment, and TDR slightly decreases neck pain at 5 years compared to ACDF. Half of the reoperations in the ACDF group were at adjacent levels.

RCT

Table 41.

Evidence Table: Cervical Fusion Graft Site

Good evidence

Evidence statement

Design

In the setting of ACDF, P-15 (trademark name i-Factor), a 15 amino acid peptide, is noninferiorto local bone autograft for achieving radiographic fusion, improvement in neck disability, and neurologic success, and has a safety profile similar to that of autograft.

RCT

Table 42.

Evidence Table: Cervical 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

Some evidence

Evidence statement

Design

In cervical fusion for degenerative disease, iliac crest autograft provides greater fusion rates, but cages are a valid alternative as cages result in fewer complications from surgery.

Meta analysis

In the setting of ACDF, a zero-profile implant is less likely to lead to postoperative dysphagia than a conventional cervical plate for up to 1 year after the operation.

Meta analysis

In the setting of ACDF, a PEEK cage filled with bone graft substitute in the form of calcium sulfate and demineralized bone matrix achieves similar rates effusion and clinical success as a PEEK cage filled with iliac crest autograft, while eliminafing morbidity related to the donor site.

RCT

Section 8.b.iv.Cervical Total Disc Replacement (TDR)

Introduction. Cervical total disc replacement (TDR) is a surgical procedure where a degenerated disc is replaced with a prosthetic device after decompression of the neural elements is completed. 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 Cervical TDR.

* Absolute and relative contraindications include:

o significant spinal deformity and scoliosis;

o symptomatic facet joint arthrosis;

o osteopenia, osteoporosis, or any metabolic bone disease;

o spinal instability at the pathologic level;

o spinal instability at an adjacent level that is not appropriate for fusion;

o deficient posterior elements;

o infection;

o previous compression or burst fracture;

o spondylolisthesis > 3 mm;

o spondylolysis;

o chronic steroid or other medication use that interferes with bone or soft tissue healing;

o allergy to device materials;

o morbid obesity (e.g., body mass index > 40 kg/m2 or over 100 pounds overweight);

o active malignancy; or o generalized chronic pain.

Complications of Cervical TDR.

* Complications include nerve and vascular injury, dural tears, malpositioning/suboptimal positioning of prosthesis, implant failure, complex regional pain syndrome, and need for reoperation.

Recommendations.

Core Requirements.

Recommendation 154. Psychological evaluation is required to assess suitability for cervical 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 155. Cervical TDR is reserved for patients who meet either of the following sets of criteria:

either

* symptomatic 1- or 2- level disc disease established by objective testing (e.g., CT scan or MRI) with established radiculopathy or myelopathy unrelieved after 6 weeks of active nonsurgical treatment; and

* radiculopathy or myelopathy documented by electromyography or MRI with correlated objective findings;

or

* symptoms unrelieved after 6 months of active nonsurgical treatment; and

* all pain generators are adequately defined and treated; and

* all physical medicine and manual therapy interventions are completed; and

* imaging studies demonstrate disc pathology requiring decompression; and

* psychosocial evaluation as outlined in recommendation 154, with confounding issues addressed (table 43).

Recommendation 156. If there are signs suggestive of facet-mediated pain, the pain must be evaluated with medial branch blocks before proceeding with disc replacement.

Recommendation 157. A trial of multi-disciplinary therapy must occur prior to proceeding with surgery.

Recommendation 158. Surgeons performing total disc arthroplasty must have attended training courses or undergone disc replacement training in fellowship. It is highly recommended that the surgeon is mentored and proctored.

Evidence Tables.

Table 43.

Evidence Table: Total Disc Arthroplasty Versus Spinal Fusion

Summary:

Both CDA and ACDF are safe and effective interventions for patients with cervical degenerative disc disease. CDA leads to greater improvements in pain and disability, and fewer reoperations, than ACDF.

Strong evidence

Evidence statement

Design

For patients with cervical degenerative disc disease at 1 or 2 levels, both CDA and ACDF are safe and effective interventions leading to symptomatic relief and functional improvement.

Meta analysis

In patients with single level radiculopathy or myelopathy, cervical artificial disc produces 2-year success rates at least equal to those of ACDF with allograft interbody fusion and an anterior plate.

Meta analysis

For patients with single-level cervical degenerative disc disease, there is strong evidence that both CDA and ACDF are safe and effective interventions leading to symptomatic relief and functional improvement.

Systematic review

Good evidence

CDA is associated with fewer repeat operations at adjacent spine levels than ACDF for the first several years after the surgery is performed.

Systematic review

CDA leads to slightly better outcomes than ACDF for improvements in neck and arm pain and cervical spine function.

Systematic review

In patients with stable 1 or 2 level cervical disc disease who have minimal facet joint degeneration and bone mineral density greater than a T-score of -1.5, and who do not have axial neck pain as the sole presenting symptom, treatment with either TDR or ACDF are likely to alleviate pain and disability for at least 7 years, and that the TDR procedure is likely to confer greater benefit than fusion. Reoperation rates may be lower with disc replacement but this inference must be made with considerable caution.

RCT

Overall success, ascertained by improvement in neck disability scores combined with favorable neurological outcome and no repeat surgery at the operated level, is better with CDA than with ACDF.

Meta analysis

In the setting of radiographically stable cervical degenerative disc disease from C3 to C7 at 2 adjacent levels, CDA is at least as safe and effective as fusion with an anterior plate and a ring allograft, and is likely to require fewer reoperations in the first 2 years after surgery.

RCT

Some evidence

Evidence statement

Design

Cervical TDR requires fewer revision operations than ACDF after the first 2 years of treatment, and TDR slightly decreases neck pain at 5 years compared to ACDF. Half of the reoperations in the ACDF group were at adjacent levels.

RCT

In patients with single-level cervical radiculopathy, without signs of myelopathy and with preservation of at least 3mm of disc height, equally good improvements in neck disability are expected after 2 years with any of 3 operations: anterior cervical discectomy alone, anterior cervical discectomy with fusion and a PEEK cage, or anterior CDA.

Evidence is lacking to suggest that the development of adjacent segment degeneration is significantly different after 2 years with 1 or another of these 3 surgical options.

RCT

Section 8.b.v.Spinal Cord Stimulators

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 159. 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.

Section 8.b.vi.Epiduroscopy with Epidural Lysis of Adhesions

Introduction. Epiduroscopy and epidural lysis of adhesions involves the introduction of a fiberoptic endoscope into the epidural space. 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 160. Epiduroscopy and mechanical lysis of adhesions and epiduroscopy-directed steroid injections are not recommended.

Evidence Tables. See the Chronic Pain Disorder MTGs for evidence.

7 CCR 1101-3-17-08-8

37 CR 13, July 10, 2014, effective 7/30/2014
38 CR 01, January 10, 2015, effective 2/1/2015
38 CR 05, March 10, 2015, effective 4/1/2015
38 CR 11, June 10, 2015, effective 7/1/2015
38 CR 17, September 10, 2015, effective 1/1/2016
39 CR 04, February 25, 2016, effective 3/16/2016
39 CR 13, July 10, 2016, effective 7/30/2016
39 CR 16, August 25, 2016, effective 9/14/2016
39 CR 19, October 10, 2016, effective 1/1/2017
40 CR 03, February 10, 2017, effective 3/2/2017
40 CR 11, June 10, 2017, effective 7/1/2017
40 CR 21, November 10, 2017, effective 11/30/2017
40 CR 18, September 25, 2017, effective 1/1/2018
40 CR 20, October 25, 2017, effective 1/1/2018
41 CR 11, June 10, 2018, effective 7/1/2018
41 CR 19, October 10, 2018, effective 1/1/2019
41 CR 20, October 25, 2018, effective 1/1/2019
41 CR 23, December 10, 2018, effective 1/1/2019
42 CR 01, January 10, 2019, effective 1/30/2019
42 CR 11, June 10, 2019, effective 6/30/2019
42 CR 12, June 25, 2019, effective 7/15/2019
42 CR 21, November 10, 2019, effective 11/30/2019
42 CR 20, October 25, 2019, effective 1/1/2020
42 CR 23, December 10, 2019, effective 1/1/2020
43 CR 03, February 10, 2020, effective 1/1/2020
43 CR 07, April 10, 2020, effective 4/30/2020
43 CR 11, June 10, 2020, effective 7/1/2020
43 CR 16, August 25, 2020, effective 10/14/2020
43 CR 21, November 10, 2020, effective 1/1/2021
44 CR 07, April 10, 2021, effective 4/30/2021
44 CR 08, April 25, 2021, effective 7/1/2021
44 CR 13, July 10, 2021, effective 7/30/2021
44 CR 20, October 25, 2021, effective 1/1/2022
44 CR 23, December 10, 2021, effective 1/1/2022
44 CR 23, December 10, 2021, effective 1/10/2022
45 CR 01, January 10, 2022, effective 1/30/2022
45 CR 11, June 10, 2022, effective 7/1/2022
45 CR 13, July 10, 2022, effective 8/10/2022
45 CR 21, November 10, 2022, effective 12/6/2022
46 CR 01, January 10, 2023, effective 12/6/2022
45 CR 19, October 10, 2022, effective 1/1/2023
46 CR 02, January 25, 2022, effective 1/1/2023
46 CR 02, January 25, 2023, effective 3/2/2023
46 CR 05, March 10, 2023, effective 3/30/2023