La. Admin. Code tit. 40 § I-2131

Current through Register Vol. 50, No. 9, September 20, 2024

Section I-2131 - Therapeutic Procedures-Non-Operative

A. Non-operative therapeutic rehabilitation is applied to patients with CRPS or SMP who experience chronic and complex problems of de-conditioning and functional disability. Treatment modalities may be utilized sequentially or concomitantly depending on chronicity and complexity of the problem, and treatment plans should always be based on a diagnosis utilizing appropriate diagnostic procedures.

B. Before initiation of any therapeutic procedure, the authorized treating physician, employer and insurer must consider these important issues in the care of the injured worker:

1. Patients undergoing therapeutic procedure(s) should be released or returned to modified or restricted duty during their rehabilitation at the earliest appropriate time. Refer to Return-to-Work for detailed information.

2. Reassessment of the patient's status in terms of functional improvement should be documented after each treatment. If patients are not responding within the recommended time periods, alternative treatment interventions, further diagnostic studies or consultations should be pursued. Continued treatment should be monitored using objective measures such as:

a. Return to work or maintaining work status.

b. Fewer restrictions at work or performing or limitations in activities of daily living (ADL).

c. Decrease in usage of medications.

d. Measurable functional gains, such as increased range of motion or documented increase in strength.

3. Clinicians should provide and document education to the patient. No treatment plan is complete without addressing issues of individual and/or group patient education as a means of facilitating self-management of symptoms.

4. Psychological or psychosocial screening should be performed on all chronic pain patients.

C. The following procedures are listed in alphabetical order.

1. Acupuncture is an accepted and widely used procedure for the relief of pain and inflammation and there is some scientific evidence to support its use. Credentialed practitioners must perform acupuncture evaluations, with experience in evaluation and treatment of chronic pain patients. The exact mode of action is only partially understood. Western medicine studies suggest that acupuncture stimulates the nervous system at the level of the brain, promotes deep relaxation, and affects the release of neurotransmitters. Acupuncture is commonly used as an alternative or in addition to traditional Western pharmaceuticals. It is commonly used when pain medication is reduced or not tolerated. It may be used as an adjunct to physical rehabilitation, surgical intervention, and or as part of multidisciplinary treatment to hasten the return of functional activity. Acupuncture should be performed by licensed practitioners.

a. Refer to the Chronic Pain Medical Treatment guideline's for detailed information on acupuncture and timeframe parameters.

2. Biofeedback is a generally well-accepted form of behavioral medicine that helps patients learn self-awareness and self-regulation skills for the purpose of gaining greater control of their physiology. Biofeedback treatment is intended to assist patients in managing stress-related psychophysiological reactions that may arise as a reaction to organic pain, or which may cause pain. The biofeedback specialist may utilize a variety of interventions for teaching physiological self-management. Biological feedback may then be provided through mechanisms ranging from simple devices to electronic instrumentation, and displayed or fed back to the patient visually, auditorially, or tactilely. This enables the patient to identify and refine effective interventions.

a. The application of biofeedback to patients with CRPS is not well researched. However, based on CRPS symptomology, temperature or skin conductance feedback modalities may be of particular interest. Refer to the Chronic Pain Medical Treatment Guideline's for detailed information on biofeedback and time parameters.

3. Disturbances of sleep are common in chronic pain. Although primary insomnia may accompany pain as an independent comorbid condition, it more commonly occurs, secondary to the pain condition itself. Exacerbations of pain often are accompanied by exacerbations of insomnia; the reverse can also occur. Sleep laboratory studies have shown disturbances of sleep architecture in pain patients. Loss of deep slow-wave sleep and increase in light sleep occur and sleep efficiency, the proportion of time in bed spent asleep, is decreased. These changes are associated with patient reports of non-restorative sleep.

a. Many chronic pain patients develop behavioral habits that exacerbate and maintain sleep disturbances. Excessive time in bed, irregular sleep routine, napping, low activity and worrying in bed are all maladaptive responses that can arise in the absence of any psychopathology. There is some evidence that behavioral modification, such as patient education and group or individual counseling, can be effective in reversing the effects of insomnia. Behavioral modifications are easily implemented and can include:

i. Maintaining a regular sleep schedule, retiring and rising at approximately the same time on weekdays and weekends.

ii. Avoiding daytime napping.

iii. Avoiding caffeinated beverages after lunchtime

iv. Making the bedroom quiet and comfortable, eliminating disruptive lights, sounds television sets, and keeping a bedroom temperature of about 65°F.

v. Avoiding alcohol or nicotine within two hours of bedtime.

vi. Avoiding large meals within two hours of bedtime.

vii. Exercising vigorously during the day, but not within two hours of bedtime, since this may raise core temperature and activate the nervous system.

viii. Associating the bed with sleep and sexual activity only, using other parts of the home for television, reading and talking on the telephone.

ix. Leaving the bedroom when unable to sleep for more than 20 minutes, retuning to the bedroom when ready to sleep again.

b. These modifications should be undertaken before sleeping medication is prescribed.

4. Injections - therapeutic. When considering the use of injections in CRPS management, the treating physician must carefully consider the inherent risks and benefits. First, it is understood that these injections are seldom meant to be "curative" but may have diagnostic or prognostic qualities and when used for therapeutic purposes they are employed in conjunction with other treatment modalities for maximum benefit. Second, education of the patient should include the proposed goals of the injections, expected gains, risks or complications, and alternative treatment. Lastly, reassessment of the patient's status in terms of functional improvement should be documented after each injection and/or series of injections.

a. Any continued use of injections should be monitored using objective measures such as:

i. Return to work or maintaining work status.

ii. Fewer restrictions at work or when performing activities of daily living (ADL).

iii. Decrease in usage of medications.

iv. Measurable functional gains, such as increased range of motion or documented increase in strength.

(a). Visual analog scales (VAS) provide important subjective data but are not an appropriate measure of function.

(b). The physician must be aware of the possible placebo effect as well as the long-term effects of injections related to the patient's physical and mental status. Strict adherence to contraindications, both absolute and relative, may prevent potential complications. Subjecting the patient to potential risks, i.e., needle trauma, infection, nerve injury, or systemic effects of local anesthetics and corticosteroids, must be considered before the patient consents to such procedures.

b. Sympathetic Injections

i. Description. Sympathetic injections are generally accepted, well-established procedures. They include stellate ganglion blocks, Kuntz Fiber blocks, thoracic sympathetic blocks, lumbar sympathetic, and intravenous regional (Bier) blocks. Regional blocks frequently use bretylium with additional agents (narcotics and or anti-inflammatory drugs). There is some evidence that bretylium reduces pain intensity. It is recommended that all patients receiving therapeutic blocks participate in PT and/or OT immediately after each block as well as in an appropriate exercise program that may include a functionally directed rehabilitation program.

ii. Indications. Pain relief and functional improvement from previous diagnostic or therapeutic blocks.

iii. Special Considerations. Except for Bier blocks, fluoroscopic and/or CT guidance during procedures is recommended to document technique and needle placement; an experienced physician should perform the procedure. The practitioner should participate in ongoing injection training workshops provided by organizations such as the American Society of Interventional Pain Physicians (ASIPP) and the Spinal Intervention Society (SIS) and be knowledgeable in radiation safety. In addition, practitioners should obtain fluoroscopy training and radiation safety credentialing from their Departments of Radiology, as applicable.

iv. Complications may include transient neurapraxia, nerve injury, inadvertent spinal injection, infection, venous or arterial vertebral puncture, laryngeal paralysis, respiratory arrest, vasovagal effects, as well as permanent neurologic damage.

v. Contraindications. Absolute contraindications of therapeutic injections include:

(a). bacterial infection systemic or localized to region of injection,

(b). bleeding diatheses,

(c). hematological conditions, and

(d). possible pregnancy. Relative contraindications of therapeutic injections may include: aspirin/antiplatelet therapy (drug may be held for at least 3 days prior to injection).

vi. Treatment Parameters. To be effective as a treatment modality, the patient should be making measurable progress in their rehabilitation program and should be achieving an increasing or sustained duration of relief between blocks. If appropriate outcomes are not achieved, changes in treatment should be undertaken.

(a). Time to produce effect: one to three blocks

(b). Frequency: Variable, depending upon duration of pain relief and functional gains. During the first two weeks of treatment, blocks may be provided every three to five days, based on patient response. After the first two weeks, blocks may be given weekly with tapering for a maximum of seven injections over six weeks. If pain relief and functional gains plateau before seven injections in six weeks, a trial of spinal cord or DRG spinal stimulation should be considered. Refer to chronic pain guidelines for treatment parameters.

(c). Optimum duration: three months.

(d). Maximum duration: three to four months for initial treatment. For the use of blocks during maintenance care, refer to the Maintenance Care section for treatment parameters.

(e). Trigger Point Injections: May be appropriate when myofascial trigger points are present on examination. Refer to chronic pain guidelines for treatment parameters.

(f). Peripheral Nerve Blocks: May be appropriate when peripheral nerve pathology is identified. Refer to chronic pain guidelines for treatment parameters.

(g). Intravenous lidocaine: May be used as a prognostic indicator for the use of mexilitine. It is infrequently used as a therapeutic treatment.

vii. Radiofrequency Sympathectomy in CRPS

(a). Thoracic, Lumbar and Sacral sympathetic ganglia, including Kuntz Fibers, Splanchnic Ganglia, sacral and L5 sympathetic ganglia, can be treated with RF ablation after successful diagnostic blocks with at least 50 percent relief of pain and improved function. This procedure can be repeated no more than every 6 months.

5. Interdisciplinary rehabilitation programs are the gold standard of treatment for individuals with chronic pain who have not responded to less intensive modes of treatment. In addition, there are current studies to support the use of pain programs. There is strong evidence that interdisciplinary programs improve function in chronic pain and moderate evidence that these programs decrease pain in these patients.

a. These programs should assess the impact of pain and suffering on the patient's medical, physical, psychological, social, and/or vocational functioning. In general, interdisciplinary programs deal with irreversible, painful musculoskeletal, neurological, and other chronic painful disorders and psychological issues, including drug dependence, high levels of stress and anxiety, failed surgery and pre-existing or latent psychopathology. The number of professions involved in the team in a chronic pain program may vary due to the complexity of the needs of the person served. The OWCA recommends consideration of referral to an interdisciplinary program within 6 months post-injury in patients with delayed recovery unless surgical interventions or other medical complications intervene.

b. Chronic pain patients need to be treated within a continuum of treatment intensity. Chronic pain programs are available with services provided by a coordinated interdisciplinary team within the same facility (formal) or as coordinated by the authorized treating physician (informal). Formal programs are able to provide coordinated, high intensity level of services and are recommended for most chronic pain patients who have received multiple therapies during acute management. Informal programs offer a lesser intensity of service and may be considered for patients who are currently employed, those who cannot attend all day programs, those with language barriers, or those living in areas not offering formal programs. Before treatment has been initiated, the patient, physician, and insurer should agree on treatment approach, methods, and goals. Generally the type of program needed will depend on the degree of impact the pain has had on the patient's medical, physical, psychological, social and/or vocational functioning.

c. Inpatient pain rehabilitation programs are rarely needed but may be necessary for patients with any of the following conditions: High risk for medical instability; Moderate to severe impairment of physical/functional status; Moderate to severe pain behaviors; Moderate impairment of cognitive and/or emotional status; Dependence on medications from which he or she needs to be withdrawn; and the need for 24-hour supervised nursing.

d. Interdisciplinary pain programs, whether formal or informal, should be comprised of the following dimensions:

i. Communication. To ensure positive functional outcomes, communication between the patient, insurer and all professionals involved must be coordinated and consistent. Any exchange of information must be provided to all professionals, including the patient. Care decisions would be communicated to all.

ii. Documentation. Through documentation by all professionals involved and/or discussions with the patient, it should be clear that functional goals are being actively pursued and measured on a regular basis to determine their achievement or need for modification.

iii. Treatment Modalities. Use of modalities may be necessary early in the process to facilitate compliance with and tolerance to therapeutic exercise, physical conditioning, and increasing functional activities. Active treatments should be emphasized over passive treatments. Active treatments should encourage self-coping skills and management of pain, which can be continued independently at home or at work. Treatments that can foster a sense of dependency by the patient on the caregiver should be avoided. Treatment length should be decided based upon observed functional improvement. For a complete list of Active and Passive Therapies, refer to those Subparagrahps of this guideline. All treatment timeframes may be extended based upon the patients positive functional improvement.

iv. Therapeutic Exercise Programs. There is strong evidence that these programs, including aerobic conditioning and strengthening, are superior to treatment programs that do not include exercise. There is no sufficient evidence to support the recommendation of any particular exercise regimen over any other exercise regimen. A therapeutic exercise program should be initiated at the start of any treatment rehabilitation. Such programs should emphasize education, independence, and the importance of an on-going exercise regime.

v. Return-to-Work. The authorized treating physician should continually evaluate the patient for their potential to return to work. When return-to-work is an option, it may be appropriate to implement a Work Hardening Program (as described in this Section). For patients currently employed, efforts should be aimed at keeping them employed. For more specific information regarding return-to-work, refer to the Return-to-work section in this guideline.

vi. Patient Education. Patients with pain need to re-establish a healthy balance in lifestyle. All providers should educate patients on how to overcome barriers to resuming daily activity, including pain management, decreased energy levels, financial constraints, decreased physical ability, and change in family dynamics.

vii. Psychosocial Evaluation and Treatment. Psychosocial evaluation should be initiated, if not previously done. Providers of care should have a thorough understanding of the patients personality profile; especially if dependency issues are involved. Psychosocial treatment may enhance the patients ability to participate in pain treatment rehabilitation, manage stress, and increase their problem-solving and self-management skills.

viii. Vocational Assistance. Vocational assistance can define future employment opportunities or assist patients in obtaining future employment. Refer to Return-to-work section for detailed information.

e. Interdisciplinary programs are characterized by a variety of disciplines that participate in the assessment, planning, and/or implementation of the treatment program. These programs are for patients with greater levels of perceived disability, dysfunction, de-conditioning and psychological involvement. The following programs are listed in order of decreasing intensity.

i. Formal Rehabilitation Programs

(a). Interdisciplinary Pain Rehabilitation. An Interdisciplinary Pain Rehabilitation Program provides outcomes-focused, coordinated, goal-oriented interdisciplinary team services to measure and improve the functioning of persons with pain and encourage their appropriate use of health care system and services. The program can benefit persons who have limitations that interfere with their physical, psychological, social, and/or vocational functioning. The program shares information about the scope of the services and the outcomes achieved with patients, authorized providers, and insurers.

(b). The interdisciplinary team maintains consistent integration and communication to ensure that all interdisciplinary team members are aware of the plan of care for the patient, are exchanging information, and implement the plan of care. The team members make interdisciplinary team decisions with the patient and then ensure that decisions are communicated to the entire care team.

(c). The medical director of the pain program should be board certified in his or her specialty area, have at least two years full-time experience in an interdisciplinary pain rehabilitation program, and ideally be board certified in pain management. Individuals who assist in the accomplishment of functional, physical, psychological, social and vocational goal must include, at the least, a medical director, pain physician(s), psychologist, Biofeedback Therapist, Occupational Therapist, Physical Therapist, and Registered Nurse. Other disciplines on the team may include, but are not limited to, case manager, exercise physiologist, psychiatrist, and/or nutritionist.

(i). time to produce effect: three to four weeks;

(ii). frequency: No less than five hours/day, five days/week;

(iii). optimum duration: three to four weeks five times a week, followed by six to nine weeks of follow-up one to three times a week;

(iv). maximum duration: four months, including follow-up. Periodic review and monitoring thereafter on an as needed basis, is founded upon the documented maintenance of functional gains.

(d). Work hardening is an interdisciplinary program addressing a patients employability and return-to-work. It includes a progressive increase in the number of hours per day that a patient completes work simulation tasks until the patient can tolerate a full workday. A full workday is case specific and is defined by the previous employment of the patient. This is accomplished by addressing the medical, psychological, behavioral, physical, functional, and vocational components of employability and return-to-work.

(e). The interdisciplinary team should, at a minimum, be comprised of a qualified medical director who is board certified with documented training in occupational rehabilitation, team physicians having experience in occupational rehabilitation, occupational therapy, physical therapy, case manager, and psychologist. As appropriate, the team may also include: chiropractor, RN, or vocational specialist.

(i). time to produce effect: two weeks;

(ii). frequency: two to five visits per week, up to eight hours/day;

(iii). optimum duration: two to four weeks;

(iv). maximum duration: six weeks. Participation in a program beyond six weeks must be documented with respect to need and the ability to facilitate positive symptomatic or functional gains.

ii. Informal Rehabilitation Program. A coordinated interdisciplinary pain rehabilitation program is one in which the authorized treating physician coordinates all aspects of care. This type of program is similar to the formal programs in that it is goal oriented and provides interdisciplinary rehabilitation services to manage the needs of the patient in the following areas: functional, medical, physical, psychological, social, and vocational.

(a). This program is different from a formal program in that it involves lesser frequency and intensity of services/treatment. Informal rehabilitation is geared toward those patients who do not need the intensity of service offered in a formal program or who cannot attend an all-day program due to employment, daycare, language or other barriers.

(b). Patients should be referred to professionals experienced in outpatient treatment of chronic pain. The OWCA recommends the authorized treating physician consult with physicians experienced in the treatment of chronic pain to develop the plan of care.

(i). time to produce effect: three to eight weeks;

(ii). frequency: two to six hours per day, two to five days each week;

(iii). optimum duration: 6 to 12 weeks, including follow-up;

(iv). maximum duration: four months, including follow-up. Periodic review and monitoring thereafter on an as needed basis, is founded upon the documented maintenance of functional gains.

6. Medications. There is no single formula for pharmacological treatment of patients with chronic nonmalignant pain. A thorough medication history, including use of alternative and over the counter medications, should be performed at the time of the initial visit and updated periodically. Appropriate application of pharmacological agents depends on the patient's age, past history (including history of substance abuse), drug allergies, and the nature of all medical problems. It is incumbent upon the physician to thoroughly understand pharmacological principles when dealing with the different drug families and their respective side effect, bioavailability profiles and primary reason for each medication's usage.

a. Control of chronic non-malignant pain is expected to involve the use of medication. Strategies for pharmacological control of pain cannot be precisely specified in advance. Rather, drug treatment requires close monitoring of the patient's response to therapy, flexibility on the part of the prescriber, and a willingness to change treatment when circumstances change. Many of the drugs discussed in the medication section were licensed for indications other than analgesia, but are effective in the control of many types of chronic pain.

b. All medications should be given an appropriate trial in order to test for therapeutic effect. Trials of medication requiring specific therapeutic drug levels may take several months to achieve, depending upon the half-life of the drug. It is recommended that patients with CRPS be maintained on drugs that have the least serious side effects. For example, patients need to be tried or continued on acetaminophen and or antidepressant medications whenever feasible as part of their overall treatment for chronic pain. It is recommended that use of opioid analgesic and sedative hypnotic medications in chronic pain patients be used in a very limited manner, with total elimination desirable whenever clinically feasible. See Chronic Pain Medication Section for further guidance.

c. For the clinician to interpret the following material, it should be noted that: drug profiles listed are not complete; dosing of drugs will depend upon the specific drug, especially for off-label use; and not all drugs within each class are listed, and other drugs within the class may be appropriate for individual cases. Clinicians should refer to informational texts or consult a pharmacist before prescribing unfamiliar medications or when there is a concern regarding drug interactions.

d. The following drug classes are listed in alphabetical order, not in order of suggested use.

i. Anticonvulsants. Although the mechanism of action of anticonvulsant drugs in neuropathic pain states remains to be fully defined, they appear to act as channel blocking agents. A large variety of sodium channels are present in nervous tissue, and some of these are important mediators of nociception, as they are found primarily in unmyelinated fibers and their density increases following nerve injury. While the pharmacodynamic effects of the various anticonvulsant drugs are similar, the pharmacokinetic effects differ significantly. Gabapentin and pregablin, by contrast, are relatively non-significant enzyme inducers, creating fewer drug interactions. All patients on these medications should be monitored for suicidal ideation. Many of these medications are not recommended for women of child-bearing age due to possible teratogenic effects.

(a). Gabapentin and pregabalin are commonly prescribed for neuropathic pain. There is an association between older anticonvulsants including gabapentin and non-traumatic fractures for patients older than 50; this should be taken into account when prescribing these medications.

(b). Gabapentin and pregabalin have indirect (not GABA A or GABA B receptor mediated) GABA-mimetic qualities rather than receptor mediated actions. This can potentially result in euphoria, relaxation, and sedation. It is likely that they also affect the dopaminergic "reward" system related to addictive disorders. Misuse of these medications usually involves doses 3 to 20 times that of the usual therapeutic dose. The medication is commonly used with alcohol or other drugs of abuse. Providers should be aware of the possibility and preferably screen patients for abuse before prescribing these medications. Withdrawal symptoms, such as insomnia, nausea, headache, or diarrhea, are likely when high doses of pregabalin have been used. Tolerance can also develop.

(c). Gabapentin (Fanatrex, Gabarone, Gralise, Horizant, Neurontin)

(i). Description-Structurally related to gamma aminobutyric acid (GABA) but does not interact with GABA receptors. Gabapentin affects the alpha-2-delta-1 ligand of voltage gated calcium channels, thus inhibiting neurotransmitter containing intra-cellular vesicles from fusing with the pre-synaptic membranes and reducing primary afferent neuronal release of neurotransmitters (glutamate, CGRP, and substance P). It may also modulate transient receptor potential channels, NMDA receptors, protein kinase C and inflammatory cytokines, as well as possibly stimulating descending norepinephrine mediated pain inhibition.

(ii). Indications-As of the time of this guideline writing, formulations of gabapentin have been FDA approved for post-herpetic neuralgia and partial onset seizures.

[a]. There is strong evidence that gabapentin is more effective than placebo in the relief of painful diabetic neuropathy and post-herpetic neuralgia.

[b]. There is some evidence that gabapentin may benefit some patients with post-traumatic neuropathic pain. There is good evidence that gabapentin is not superior to amitriptyline. There is some evidence that nortriptyline (Aventyl, Pamelor) and gabapentin are equally effective for pain relief of postherpetic neuralgia. There is some evidence that the combination of gabapentin and morphine may allow lower doses with greater analgesic effect than the drugs given separately. There is strong evidence that gabapentin is more effective than placebo for neuropathic pain, even though it provides complete pain relief to a minority of patients. There is some evidence that a combination of gabapentin and nortriptyline provides more effective pain relief than monotherapy with either drug.

(iii). Relative Contraindications-Renal insufficiency. Dosage may be adjusted to accommodate renal dysfunction.

(iv). Dosing and Time to Therapeutic Effect-Dosage should be initiated at a low dose in order to avoid somnolence and may require four to eight weeks for titration. Dosage should be adjusted individually. It is taken three to four times per day, and the target dose is 1800 mg.

(v). Major Side Effects-Confusion, sedation, dizziness, peripheral edema. Patients should also be monitored for suicidal ideation and drug abuse.

(vi). Drug Interactions-antacids.

(vii). Laboratory Monitoring-Renal function.

ii. Antidepressants are classified into a number of categories based on their chemical structure and their effects on neurotransmitter systems. Their effects on depression are attributed to their actions on disposition of norepinephrine and serotonin at the level of the synapse; although these synaptic actions are immediate, the symptomatic response in depression is delayed by several weeks. When used for chronic pain, the effects may in part arise from treatment of underlying depression, but may also involve additional neuromodulatory effects on endogenous opioid systems, raising pain thresholds at the level of the spinal cord.

(a). Pain responses may occur at lower drug doses with shorter times to symptomatic response than are observed when the same compounds are used in the treatment of mood disorders. Neuropathic pain, diabetic neuropathy, post-herpetic neuralgia, and cancer-related pain may respond to antidepressant doses low enough to avoid adverse effects that often complicate the treatment of depression. First line drugs for neuropathic pain are the tricyclics with the newer formulations having better side effect profiles. SNRIs are considered second line drugs due to their costs and the number needed to treat for a response. Duloxetine may be considered for first line use in a patient who is a candidate for pharmacologic treatment of both chronic pain and depression. SSRIs are used generally for depression rather than neuropathic pain and should not be combined with moderate to high-dose tricyclics.

(b). All patients being considered for anti-depressant therapy should be evaluated and continually monitored for suicidal ideation and mood swings.

(i). Tricyclics and Older Agents (e.g., amitriptyline, nortriptyline, doxepin [Silenor, Sinequan, Adapin], desipramine [Norpramin, Pertofrane], imipramine [Tofranil], trazodone [Desyrel, Oleptro])

[a]. Description-Serotonergics, typically tricyclic antidepressants (TCAs), are utilized for their serotonergic properties as increasing CNS serotonergic tone can help decrease pain perception in non-antidepressant dosages. TCAs decrease reabsorption of both serotonin and norepinephrine. They also impact Na channels. Amitriptyline is known for its ability to repair Stage 4 sleep architecture, a frequent problem found in chronic pain patients and to treat depression, frequently associated with chronic pain. However, higher doses may produce more cholinergic side effects than newer tricyclics such as nortriptyline and desipramine. Doxepin and trimipramine also have sedative effects.

[i]. There is some evidence that a combination of some gabapentin and nortriptyline provides more effective pain relief than monotherapy with either drug, without increasing side effects of either drug.

[b]. Indications-Some formulations are FDA approved for depression and anxiety. For the purposes of this guideline, they are recommended for neuropathic pain and insomnia. They are not recommended as a first line drug treatment for depression.

[c]. Major Contraindications-Cardiac disease or dysrhythmia, glaucoma, prostatic hypertrophy, seizures, high suicide risk, uncontrolled hypertension and orthostatic hypotension. A screening cardiogram may be done for those 40 years of age or older, especially if higher doses are used. Caution should be utilized in prescribing TCAs. They are not recommended for use in elderly patients 65 years of age or older, particularly if they are at fall risk.

[d]. Dosing and Time to Therapeutic Effect-Varies by specific tricyclic. Low dosages, less than 100 mg, are commonly used for chronic pain and/or insomnia. Lower doses decrease side effects and cardiovascular risks.

[e]. Major Side Effects-Side effects vary according to the medication used; however, the side effect profile for all of these medications is generally higher in all areas except GI distress, which is more common among the SSRIs and SNRIs. Anticholinergic side effects including, but not limited to, dry mouth, sedation, orthostatic hypotension, cardiac arrhythmia, urinary retention, and weight gain. Dry mouth leads to dental and periodontal conditions (e.g., increased cavities). Patients should also be monitored for suicidal ideation and drug abuse. Anticholinergic side effects are more common with tertiary amines (amitriptyline, imipramine, doxepin) than with secondary amines (nortriptyline and desipramine).

[f]. Drug Interactions-Tramadol (may cause seizures, both also increase serotonin/norepinephrine, so serotonin syndrome is a concern), clonidine, cimetidine (Tagemet), sympathomimetics, valproic acid (Depakene, Depakote, Epilim, Stavzor), warfarin (Coumadin, Jantoven, Marfarin), carbamazepine, bupropion (Aplezin, Budeprion, Buproban, Forfivo, Wellbutrin, Zyban), anticholinergics, quinolones.

[g]. Recommended Laboratory Monitoring-Renal and hepatic function. Electrocardiogram (EKG) for those on high dosages or with cardiac risk.

iii. Hypnotics and Sedatives: Sedative and hypnotic drugs decrease activity, induce drowsiness, and moderate agitation. Many drugs produce these effects incidental to their usual intended effects, similar to the side effects of many antihistamines and antidepressants. Due to the habit-forming potential of the benzodiazepines and other drugs found in this class, they are not routinely recommended but may be useful in some patients with chronic pain.

(a). Most insomnia in chronic pain patients should be managed primarily though behavioral interventions with medications as secondary measures (refer to Disturbances of Sleep).

(i). Zaleplon (Sonata):

[a]. description - a nonbenzodiazepine hypnotic;

[b]. indications - insomnia;

[c]. dosing and time to therapeutic effect - time of onset is 30 to 60 minutes. Due to rapid elimination, may be taken as little as 4 hours before awakening;

[d]. major side effects - dizziness, dose-related amnesia;

[e]. drug interactions - increases sedative effect of other CNS depressant drugs. Use low dose if on cimetidine;

[f]. recommended laboratory monitoring - hepatic function.

(ii). Zolpidem (Ambien)

[a]. Description A nonbenzodiazepine hypnotic, which does not appear to cause rebound insomnia. It has little respiratory depression and insignificant anxiolytic or muscle relaxant activity.

[b]. Indications Short-term use for insomnia

[c]. Time to Produce Therapeutic Effect Onset of action is 30 to 60 minutes

[d]. Major Side Effects Dizziness, dose-related amnesia.

[e]. Drug Interactions Increases sedative effect of other CNS depressant drugs.

[f]. Recommended Laboratory Monitoring Hepatic function.

iv. Opioids are the most powerful analgesics. Their use in acute pain and moderate-to-severe cancer pain is well accepted. Their use in chronic nonmalignant pain, however, is fraught with controversy and lack of scientific research. Deaths in the United States from opioids have escalated in the last 15 years. The CDC states the following in their 2016 Primary Care guideline for prescribing opioids: Opioid pain medication use presents serious risk, including overdose and opioid use disorder. From 1999 to 2014, more than 165,000 persons died from overdose related to opioid pain medication in the United States. In the past decade, while the death rates for the top leading causes of death such as heart disease and cancer have decreased substantially, the death rate associated with opioid pain medication has increased markedly. Sales of opioid pain medication have increased in parallel with opioid-related overdose deaths. The Drug Abuse Warning Network estimated that less than 420,000 emergency department visits were related to the misuse or abuse of narcotic pain relievers in 2011, the most recent year for which data are available. Opioid poisoning has also been identified in work-related populations.

(a). Effectiveness and Side Effects: Opioids include some of the oldest and most effective drugs used in the control of severe pain. The discovery of opioid receptors and their endogenous peptide ligands has led to an understanding of effects at the binding sites of these naturally occurring substances. Most of their analgesic effects have been attributed to their modification of activity in pain pathways within the central nervous system; however, it has become evident that they also are active in the peripheral nervous system. Activation of receptors on the peripheral terminals of primary afferent nerves can mediate anti-nociceptive effects, including inhibition of neuronal excitability and release of inflammatory peptides. Some of their undesirable effects on inhibiting gastrointestinal motility are peripherally mediated by receptors in the bowel wall.

(i). Most studies show that only around 50 percent of patients tolerate opioid side effects and receive an acceptable level of pain relief. Depending on the diagnosis and other agents available for treatment, the incremental benefit can be small.

(ii). There is good evidence that opioids are more efficient than placebo in reducing neuropathic pain by clinically significant amounts. There is a lack of evidence that opioids improve function and quality of life more effectively than placebo. There is good evidence that opioids produce significantly more adverse effects than placebo such as constipation, drowsiness, dizziness, nausea, and vomiting. There is a lack of evidence that they are superior to gabapentin or nortriptyline for neuropathic pain reduction.

(iii). Patients should have a thorough understanding of the need to pursue many other pain management techniques in addition to medication use in order to function with chronic pain. They should also be thoroughly aware of the side effects and how to manage them. There is strong evidence that adverse events such as constipation, dizziness, and drowsiness are more frequent with opioids than with placebo. Common side effects are drowsiness, constipation, nausea, and possible testosterone decrease with longer term use.

(b). Hyperalgesia: Administration of opioid analgesics leads not only to analgesia, but may also lead to a paradoxical sensitization to noxious stimuli. Opioid induced hyperalgesia has been demonstrated in animals and humans using electrical or mechanical pain stimuli. This increased sensitivity to mildly painful stimuli does not occur in all patients and appears to be less likely in those with cancer, clear inflammatory pathology, or clear neuropathic pain. When hyperalgesia is suspected, opioid tapering is appropriate.

(c). Opioid Induced Constipation (OIC): Some level of constipation is likely ubiquitous among chronic opioid users. An observational study of chronic opioid users who also used some type of laxative at least four times per week noted that approximately 50 percent of the patients were dissatisfied and they continue to report stool symptoms. 71 percent used a combination of natural and dietary treatment, 64.3 percent used over-the-counter laxatives, and 30 percent used prescription laxatives. Other studies report similar percentages. There are insufficient quality studies to recommend one specific type of laxative over others.

(i). The easiest method for identifying constipation, which is also recommended by a consensus, multidisciplinary group, is the Bowel Function Index. It assesses the patients impression over the last seven days for ease of defecation, feeling of incomplete bowel evacuation, and personal judgment re-constipation.

(ii). Stepwise treatment for OIC is recommended, and all patients on chronic opioids should receive information on treatment for constipation. Dietary changes increasing soluble fibers are less likely to decrease OIC and may cause further problems if GI motility is decreased. Stool softeners may be tried, but stimulant and osmotic laxatives are likely to be more successful. Osmotic laxatives include lactulose and polyethylene glycol. Stimulants include bisacodyl, sennosides, and sodium picosulfate, although there may be some concern regarding use of stimulants on a regular basis.

(iii). Opioid rotation or change in opioids may be helpful for some patients. It is possible that sustained release opioid products cause more constipation than short acting agents due to their prolonged effect on the bowel opioid receptors. Tapentadol is a u-opioid agonist and norepinephrine reuptake inhibitor. It is expected to cause less bowel impairment then oxycodone or other traditional opioids.Tapentadol may be the preferred opioid choice for patients with OIC.

(iv). Other prescription medications may be used if constipation cannot adequately be controlled with the previous measures. Naloxegol is a pegylaped naloxone molecule that does not pass the blood brain barrier and thus can be given with opioid therapy. There is good evidence that it can alleviate OIC and that 12.5 mg starting dose has an acceptable side effect profile.

(v). Methylnaltrexone does not cross the blood brain barrier and can be given subcutaneously or orally. It is specifically recommended for opioid induced constipation for patients with chronic non-cancer pain.

(vi). Misoprostol is a synthetic prostaglandin E1 agonist and has the side effect of diarrhea in some patients. It also has been tried for opioid induced constipation, although it is not FDA approved for this use.

(vii). Naldemedine is an opioid antagonist indicated for the treatment of opioidinduced constipation in adult patients with chronic pain.

(viii). Lubiprostone is a prostaglandin E1 approved for use in opioid constipation.

(ix). Most patients will require some therapeutic control for their constipation. The stepwise treatment discussed should be followed initially. If that has failed and the patient continues to have recurrent problems with experiencing severe straining, hard or lumpy stool with incomplete evacuation, or infrequent stools for 25 percent of the time despite the more conservative measures, it may be appropriate to use a pharmaceutical agent.

(d). Physiologic Responses to Opioids. Physiologic responses to opioids are influenced by variations in genes which code for opiate receptors, cytochrome P450 enzymes, and catecholamine metabolism. Interactions between these gene products significantly affect opiate absorption, distribution, and excretion. Hydromorphone, oxymorphone, and morphine are metabolized through the glucuronide system. Other opioids generally use the cytochrome P450 system. Allelic variants in the mu opiate receptor may cause increased analgesic responsiveness to lower drug doses in some patients. The genetic type can predict either lower or higher needs for opioids. For example, at least 10 percent of Caucasians lack the CYP450 2D6 enzyme that converts codeine to morphine. In some cases, genetic testing for cytochrome P450 type may be helpful. When switching patients from codeine to other medications, assume the patient has little or no tolerance to opioids. Many gene-drug associations are poorly understood and of uncertain clinical significance. The treating physician needs to be aware of the fact that the patients genetic makeup may influence both the therapeutic response to drugs and the occurrence of adverse effects. A Comprehensive genetic testing panel may be ordered by treating physician for these multiple P450 genes once in a lifetime and utilized whenever there is a question of metabolism or unusual response of any drugs used to treat pain conditions, because multiple drugs and associated genes can cause problems with opioid metabolism

(e). Adverse Events. Physicians should be aware that deaths from unintentional drug overdoses exceed the number of deaths from motor vehicle accidents in the US. Most of these deaths are due to the use of opioids, usually in combination with other respiratory depressants such as alcohol or benzodiazepines. The risk for out of hospital deaths not involving suicide was also high. The prevalence of drug abuse in the population of patients undergoing pain management varies according to region and other issues. One study indicated that one-fourth of patients being monitored for chronic opioid use have abused drugs occasionally, and one-half of those have frequent episodes of drug abuse. 80 percent of patients admitted to a large addiction program reported that their first use of opioids was from prescribed medication.

(i). There is good evidence that in generally healthy patients with chronic musculoskeletal pain, treatment with long-acting opioids, compared to treatments with anticonvulsants or antidepressants, is associated with an increased risk of death of approximately 69 percent, most of which arises from non-overdose causes, principally cardiovascular in nature. The excess cardiovascular mortality principally occurs in the first 180 days from starting opioid treatment.

(ii). There is some evidence that compared to an opioid dose under 20 MED per day, a dose of 20-50 mg nearly doubles the risk of death, a dose of 50 to 100 mg may increase the risk more than fourfold, and a dose greater than 100 mg per day may increase the risk as much as sevenfold. However, the absolute risk of fatal overdose in chronic pain patients is fairly low and may be as low as 0.04 percent. There is good evidence that prescription opioids in excess of 200 MED average daily doses are associated with a near tripling of the risk of opioid-related death, compared to average daily doses of 20 MED. Average daily doses of 100-200 mg and doses of 50-99 mg per day may be associated with a doubling of mortality risk, but these risk estimates need to be replicated with larger studies.

(iii). Doses of opioids in excess of 120 MED have been observed to be associated with increased duration of disability. Higher doses are more likely to be associated with hypo-gonadism, and the patient should be informed of this risk. Higher doses of opioids also appear to contribute to the euphoric effect. The CDC recommends Primary Care Practitioners limiting to 90 MED per day to avoid increasing risk of overdose or referral to a pain specialist.

(iv). In summary, there is strong evidence that any dose above 50 MED per day is associated with a higher risk of death and 100 mg or greater appears to significantly increase the risk. Interventional techniques such as spinal cord stimulation or intrathecal catheters and programmable pumps should be considered in order to stop oral opioids usage.

(v). Workers who eventually are diagnosed with opioid abuse after an injury are also more likely to have higher claims cost. A retrospective observational cohort study of workers compensation and short-term disability cases found that those with at least one diagnosis of opioid abuse cost significantly more in days lost from work for both groups and in overall healthcare costs for the short-term disability groups. About 0.5 percent of eligible workers were diagnosed with opioid abuse.

(f). Dependence versus Addiction. The central nervous system actions of these drugs account for much of their analgesic effect and for many of their other actions, such as respiratory depression, drowsiness, mental clouding, reward effects, and habit formation. With respect to the latter, it is crucial to distinguish between two distinct phenomena: dependence and addiction.

(i). Dependence is a physiological tolerance and refers to a set of disturbances in body homeostasis that leads to withdrawal symptoms, which can be produced with abrupt discontinuation, rapid reduction, decreasing blood levels, and/or by administration of an antagonist.

(ii). Addiction is a primary, chronic, neurobiological disease, with genetic, psychological, and environmental factors influencing its development and manifestations. It is a behavioral pattern of drug craving and seeking which leads to a preoccupation with drug procurement and an aberrant pattern of use. The drug use is frequently associated with negative consequences.

(iii). Dependence is a physiological phenomenon, which is expected with the continued administration of opioids, and need not deter physicians from their appropriate use. Before increasing the opioid dose, the physician should review other possible causes for the decline in analgesic effect. Increasing the dose may not result in improved function or decreased pain. Remember that it is recommended for total morphine milligram equivalents (MME) per day to remain at 50 or below. Consideration should be given to possible new psychological stressors or an increase in the activity of the nociceptive pathways. Other possibilities include new pathology, low testosterone level that impedes delivery of opioids to the central nervous system, drug diversion, hyperalgesia, or abusive use of the medication.

(g). Choice of Opioids. No long-term studies establish the efficacy of opioids over one year of use or superior performance by one type. There is no evidence that one long-acting opioid is more effective than another, or more effective than other types of medications, in improving function or pain. There is some evidence that long-acting oxycodone (Dazidox, Endocodone, ETH-oxydose, Oxycontin, Oxyfast, OxyIR, Percolone, Roxicodone) and oxymorphone have equal analgesic effects and side effects, although the milligram dose of oxymorphone (Opana) is one-half that of oxycodone. There is no evidence that long-acting opioids are superior to short-acting opioids for improving function or pain or causing less addiction. A number of studies have been done assessing relief of pain in cancer patients. A recent systematic review concludes that oxycodone does not result in better pain relief than other strong opioids including morphine and oxymorphone. It also found no difference between controlled release and immediate release oxycodone. There is some evidence that extended release hydrocodone has a small and clinically unimportant advantage over placebo for relief of chronic low back pain among patients who are able to tolerate the drug and that 40 percent of patients who begin taking the drug do not attain a dose which provides pain relief without unacceptable adverse effects. Hydrocodone ER does not appear to improve function in comparison with placebo. A Cochrane review of oxycodone in cancer pain also found no evidence in favor of the longer acting opioid. There does not appear to be any significant difference in efficacy between once daily hydromorphone and sustained release oxycodone. Nausea and constipation are common for both medications between 26 to 32 percent. November 21, 2017, the FDA Commissioner, Scott Gottlieb, M.D., issued a Statement to promote development of generic versions of opioids formulated to deter abuse. One year earlier the FDA issued a statement encouraging development of Abuse Deterrant Formulations for opioids as a meaningful health benefit designed to reduce opoid abuse in the U.S. and to potentially and eventually remove conventional non deterrant opioids from the market if found to be unsafe.

(i). There is some evidence that in the setting of neuropathic pain, a combination of morphine plus nortriptyline produces better pain relief than either monotherapy alone, but morphine monotherapy is not superior to nortriptyline monotherapy, and it is possible that it is actually less effective than nortriptyline.

(ii). Long-acting opioids should not be used for the treatment of acute, sub-acute, or post-operative pain, as this is likely to lead to drug dependence and difficulty tapering the medication. Additionally, there is a potential for respiratory depression to occur. The FDA requires that manufacturers develop Risk Evaluation and Mitigation Strategies (REMS) for most opioids. Physicians should carefully review the plans or educational materials provided under this program. Clinical considerations should determine the need for long-acting opioids given their lack of evidence noted above.

(iii). Addiction and abuse potentials of commonly prescribed opioid drugs may be estimated in a variety of ways, and their relative ranking may depend on the measure which is used. One systematic study of prescribed opioids estimated rates of drug misuse were estimated at 21 to 29 percent and addiction at 8 to 12 percent. There is good evidence that in the setting of new onset chronic non-cancer pain, there is a clinically important relationship between opioid prescription and subsequent opioid use disorder. Compared to no opioid use, short-term opioid use approximately triples the risk of opioid use disorder in the next 18 months. Use of opioids for over 90 days is associated with very pronounced increased risks of the subsequent development of an opioid use disorder, which may be as much as one hundredfold when doses greater than 120 MED are taken for more than 90 days. The absolute risk of these disorders is very uncertain but is likely to be greater than 6.1 percent for long duration treatment with a high opioid dose. Pain physicians should be consulted when the MED reaches 100 to develop an updated treatment plan

(iv). Hydrocodone is the most commonly prescribed opioid in the general population and is one of the most commonly abused opioids in the population. However, the abuse rate per 1000 prescriptions is lower than the corresponding rates for extended release oxycodone, hydromorphone (Dilaudid, Palladone), and methadone. Extended release oxycodone appears to be the most commonly abused opioid, both in the general population and in the abuse rate per 1000 prescriptions. Tramadol, by contrast, appears to have a lower abuse rate than for other opioids.

(v). Types of opioids are listed below.

[a]. Buprenorphine: (various formulations) is prescribed as an intravenous injection, transdermal patch, buccal film, or sublingual tablet due to lack of bioavailability of oral agents. Depending upon the formulation, buprenorphine may be indicated for the treatment of pain or for the treatment of opioid dependence (addiction).

[i]. Buprenorphine for Opioid Dependence (addiction). FDA has approved a number of buccal films including those with naloxone and a sublingual tablet to treat opioid dependence (addiction).

[ii]. Buprenorphine for Pain: The FDA has approved specific forms of an intravenous and subcutaneous injectable, transdermal patch, and a buprenorphine buccal film to treat pain. However, by law, the transdermal patch and the injectable forms cannot be used to treat opioid dependence (addiction), even by DATA-2000 waivered physicians authorized to prescribe buprenorphine for addiction. Transdermal forms may cause significant skin reaction. Buprenorphine is not recommended for most chronic pain patients due to methods of administration, reports of euphoria in some patients, and lack of proof for improved efficacy in comparison with other opioids.

[iii]. There is insufficient evidence to support or refute the suggestion that buprenorphine has any efficacy in any neuropathic pain condition.

[iv]. There is good evidence transdermal buprenorphine is not inferior to oral tramadol in the treatment of moderate to severe musculoskeletal pain arising from conditions like osteoarthritis and low back pain. The population of patients for whom it is more appropriate than tramadol is not established but would need to be determined on an individual patient basis if there are clear reasons not to use oral tramadol. In a well-done study, 63 percent of those on buccal buprenorphine achieved a 30 percent or more decrease in pain at 12 weeks compared to a 47 percent placebo response. Approximately 40 percent of the initial groups eligible for the study dropped out during the initial phase when all patients received the drug to test for incompatibility.

[v]. There is strong evidence that in patients being treated with opioid agonists for heroin addiction, methadone is more successful than buprenorphine at retaining patients in treatment. The rates of opiate use, as evidenced by positive urines, are equivalent between methadone and buprenorphine. There is strong evidence that buprenorphine is superior to placebo with respect to retention in treatment, and good evidence that buprenorphine is superior to placebo with respect to positive urine testing for opiates.

[vi]. There is an adequate meta-analysis supporting good evidence that transdermal fentanyl and transdermal buprenorphine are similar with respect to analgesia and sleep quality, and they are similar with respect to some common adverse effects such as constipation and discontinuation due to lack of effect. However, buprenorphine probably causes significantly less nausea than fentanyl, and it probably carries a lower risk of treatment discontinuation due to adverse events. It is also likely that both transdermal medications cause less constipation than oral morphine.

[vii]. Overall, due to cost and lack of superiority, buprenorphine is not a front line opioid choice. However, it may be used in those with a history of addiction or at high risk for addiction who otherwise qualify for chronic opioid use. It is also appropriate to consider buprenorphine products for tapering strategies and those on high dose morphine of 90 MED or more.

[b]. Codeine with Acetaminophen: Some patients cannot genetically metabolize codeine and therefore have no response. Codeine is not generally used on a daily basis for chronic pain. Acetaminophen dose per day should be limited to 2 grams.

[c]. Fentanyl (Actiq, Duragesic, Fentora, Sublimazem, Subsys) is not recommended for use with musculoskeletal chronic pain patients. It has been associated with a number of deaths and has high addiction potential. Fentanyl should never be used transbuccally in this population. If Fentanyl it is being considered for a very specific patient population, it requires support from a pain specialist. Subsys is only indicated for cancer pain.

[d]. Meperidine (Demerol) is not recommended for chronic pain. It and its active metabolite, normeperidine, present a serious risk of seizure and hallucinations. It is not a preferred medication for acute pain as its analgesic effect is similar to codeine.

[e]. Methadone requires special precautions given its unpredictably long half-life and nonlinear conversion from other opioids such as morphine. It may also cause cardiac arrhythmias due to QT prolongation and has been linked with a greater number of deaths due to its prolonged half-life. No conclusions can be made regarding differences in efficacy or safety between methadone and placebo, other opioids, or other treatments. There is strong evidence that in patients being treated with opioid agonists for heroin addiction, methadone is more successful than buprenorphine at retaining patients in treatment. The rates of opiate use, as evidenced by positive urines, are equivalent between methadone and buprenorphine. Methadone should only be prescribed by those with experience in managing this medication. Conversion from another opioid to methadone (or the other way around) can be very challenging, and dosing titration must be done very slowly (no more than every seven days). Unlike many other opioids, it should not be used on an "as needed" basis, as decreased respiratory drive may occur before the full analgesic effect of methadone is appreciated. If methadone is being considered, genetic screening is appropriate. CYP2B6 polymorphism appears to metabolize methadone more slowly than the usual population and may cause more frequent deaths.

[f]. Morphine may be used in the non-cancer pain population. A study in chronic low back pain suggested that individuals with a greater amount of endogenous opioids will have a lower pain relief response to morphine.

[g]. Oxycodone and Hydromorphone: There is no evidence that oxycodone (as oxycodone CR) is of value in treating people with painful diabetic neuropathy, postherpetic neuralgia, or other neuropathic conditions. There was insufficient evidence to support or refute the suggestion that hydromorphone has any efficacy in any neuropathic pain condition. Oxycodone was not associated with greater pain relief in cancer patients when compared to morphine or oxymorphone.

[h]. Propoxyphene (Darvon, Davon-N, PP-Cap) has been withdrawn from the market due to cardiac effects including arrhythmias.

[i]. Tapentadol (Nucynta) is a mu opioid agonist which also inhibits serotonin and norepinephrine reuptake activity. It is currently available in an intermediate release formulation and may be available as extended release if FDA approved. Due to its dual activity, it can cause seizures or serotonin syndrome, particularly when taken with other SSRIs, SNRIs, tricyclics, or MAO inhibitors. It has not been tested in patients with severe renal or hepatic damage. It has similar opioid abuse issues as other opioid medication; however, it is promoted as having fewer GI side effects, such as constipation. There is good evidence that extended release tapentadol is more effective than placebo and comparable to oxycodone. In that study, the percent of patients who achieved 50 percent or greater pain relief was: placebo, 18.9 percent, tapentadol, 27.0 percent, and oxycodone, 23.3 percent. There is some evidence that tapentadol can reduce pain to a moderate degree in diabetic neuropathy, average difference 1.4/10 pain scale, with tolerable adverse effects. However, a high quality systematic review found inadequate evidence to support tapentadol to treat chronic pain. Tapentadol is not recommended as a first line opioid for chronic, subacute, or acute pain due to the cost and lack of superiority over other analgesics. There is some evidence that tapentadol causes less constipation than oxycodone. Therefore, it may be appropriate for patients who cannot tolerate other opioids due to GI side effects.

[j]. Tramadol (Rybix, Ryzolt, Ultram)

[i]. Description: an opioid partial agonist that does not cause GI ulceration or exacerbate hypertension or congestive heart failure. It also inhibits the reuptake of norepinephrine and serotonin which may contribute to its pain relief mechanism. There are side effects similar to opioid side effects and may limit its use. They include nausea, sedation, and dry mouth.

[ii]. Indications: mild to moderate pain relief. As of the time of this guideline writing, formulations of tramadol have been FDA approved for management of moderate to moderately severe pain in adults. This drug has been shown to provide pain relief equivalent to that of commonly prescribed NSAIDs. Unlike other pure opioids agonists, there is a ceiling dose to tramadol due to its serotonin activity (usually 300-400 mg per day). There is some evidence that it alleviates neuropathic pain following spinal cord injury. There is inadequate evidence that extended-release tramadol/acetaminophen in a fixed-dose combination of 75 mg/650 mg is more effective than placebo in relieving chronic low back pain; it is not more effective in improving function compared to placebo. There is some evidence that tramadol yields a short-term analgesic response of little clinical importance relative to placebo in post-herpetic neuralgia which has been symptomatic for approximately six months. However, given the effectiveness of other drug classes for neuropathic pain, tramadol should not be considered a first line medication. It may be useful for patients who cannot tolerate tricyclic antidepressants or other medications.

[iii]. Contraindications: use cautiously in patients who have a history of seizures, who are taking medication that may lower the seizure threshold, or taking medications that impact serotonin reuptake and could increase the risk for serotonin syndrome, such as monoamine oxidase inhibitors (MAO) inhibitors, SSRIs, TCAs, and alcohol. Use with caution in patients taking other potential QT prolonging agents. Not recommended in those with prior opioid addiction. Has been associated with deaths in those with an emotional disturbance or concurrent use of alcohol or other opioids. Significant renal and hepatic dysfunction requires dosage adjustment.

[iv]. Side effects: may cause impaired alertness or nausea. This medication has physically addictive properties, and withdrawal may follow abrupt discontinuation.

[v]. Drug interactions: opioids, sedating medications, any drug that affects serotonin and/or norepinephrine (e.g., SNRIs, SSRIs, MAOs, and TCAs).

[vi]. Laboratory Monitoring: renal and hepatic function.

(vi). Health care professionals and their patients must be particularly conscientious regarding the potential dangers of combining over-the-counter acetaminophen with prescription medications that also contain acetaminophen. Opioid and acetaminophen combination medication are limited due to the acetaminophen component. Total acetaminophen dose per day should not exceed 4 grams per any 24-hour period and is preferably limited to 2 grams per day to avoid possible liver damage.

(vii). Indications. The use of opioids is well accepted in treating cancer pain, where nociceptive mechanisms are generally present due to ongoing tissue destruction, expected survival may be short, and symptomatic relief is emphasized more than functional outcomes. In chronic non-malignant pain, by contrast, tissue destruction has generally ceased, meaning that central and neuropathic mechanisms frequently overshadow nociceptive processes. Expected survival in chronic pain is relatively long, and return to a high-level of function is a major goal of treatment. Therefore, approaches to pain developed in the context of malignant pain may not be transferable to chronic non-malignant pain. Opioids are generally not the best choice of medication for controlling neuropathic pain. Tricyclics, SNRIs, and anticonvulsants should be tried before considering opioids for neuropathic pain.

[a]. In most cases, analgesic treatment should begin with acetaminophen, aspirin, NSAIDs, and possibly Baclofen or Tizanidine. While maximum efficacy is modest, they may reduce pain sufficiently to permit adequate function. When these drugs do not satisfactorily reduce pain, medications specific to the diagnosis should be used (e.g., neuropathic pain medications as outlined in Section G.10, Medications).

[b]. There is good evidence from a prospective cohort study that in the setting of common low back injuries, when baseline pain and injury severity are taken into account, a prescription for more than seven days of opioids in the first six weeks is associated with an approximate doubling of disability one year after the injury. Therefore, prescribing after two weeks in a non-surgical case requires a risk assessment. If prescribing beyond four weeks, a full opioid trial is suggested including toxicology screen. Best practice suggests that whenever there is use of opioids for more than seven days, providers should follow all recommendations for screening and follow-ups of chronic pain use.

[c]. Consultation or referral to a pain specialist behavioral therapist should be considered when the pain persists but the underlying tissue pathology is minimal or absent and correlation between the original injury and the severity of impairment is not clear. Consider consultation if suffering and pain behaviors are present and the patient manifests risk behaviors described below, or when standard treatment measures have not been successful or are not indicated.

[d]. A psychological consultation including psychological testing (with validity measures) is indicated for all chronic pain patients as these patients are at high risk for unnecessary procedures and treatment and prolonged recovery.

[e]. Many behaviors have been found related to prescription-drug abuse patients. None of these are predictive alone, and some can be seen in patients whose pain is not under reasonable control; however, the behaviors should be considered warning signs for higher risk of abuse or addiction by physicians prescribing chronic opioids. Refer to Subsection, High Risk Behavior, below.

(ix). Recommendations for Opioid Use. When considering opioid use for moderate to moderately severe chronic pain, a trial of opioids must be accomplished as described below and the patient must have failed other chronic pain management regimes. Physicians should complete the education recommended by the FDA, risk evaluation and mitigation strategies (REMS) provided by drug manufacturing companies.

[a]. General Indications. There must be a clear understanding that opioids are to be used for a limited term in the first instance (see trial indications below). The patient should have a thorough understanding of all of the expectations for opioid use. The level of pain relief is expected to be relatively small, two to three points on a VAS pain scale, although in some individual patients it may be higher. For patients with a high response to opioid use, care should be taken to assure that there is no abuse or diversion occurring. The physician and patient must agree upon defined functional goals as well as pain goals. If functional goals are not being met, the opioid trial should be reassessed. The full spectrum of side effects should be reviewed. The shared decision making agreement signed by the patient must clarify under what term the opioids will be tapered. Refer to Subsection on the shared decision making agreement, below.

[b]. Therapeutic Trial Indications. A therapeutic trial of opioids should not be employed unless the patient has begun multi-disciplinary pain management. The trial shall last one month. If there is no functional effect, the drug should be tapered. Chronic use of opioids should not be prescribed until the following have been met:

[i]. the failure of pain management alternatives, including active therapies, cognitive behavioral therapy, pain self-management techniques, and other appropriate medical techniques;

[ii]. physical and psychological and/or psychiatric assessment including a full evaluation for alcohol or drug addiction, dependence or abuse, performed by two specialists with one being the authorized treating physician. The patient should be stratified as to low, medium, or high risk for abuse based on behaviors and prior history of abuse. High risk patients are those with active substance abuse of any type or a history of opioid abuse. These patients should generally not be placed on chronic opioids. If it is deemed appropriate to do so, physician addiction specialists should be monitoring the care. Moderate risk factors include a history of non-opioid substance abuse disorder, prior trauma particularly sexual abuse, tobacco use, widespread pain, poor pain coping, depression, and dysfunctional cognitions about pain and analgesic medications (see below). Preexisting respiratory or memory problems should also be considered. Patients with a past history of substance abuse or other psychosocial risk factors should be co-managed with a physician addiction specialist;

[iii]. risk factors to consider: history of severe post-operative pain, opioid analgesic tolerance (daily use for months), current mixed opioid agonist/antagonist treatment (e.g., buprenorphine, naltrexone), chronic pain (either related or unrelated to the surgical site), psychological comorbidities (e.g., depression, anxiety, catastrophizing), history of substance use disorder, history of "all over body pain", history of significant opioid sensitivities (e.g., nausea, sedation), and history of intrathecal pump use or nerve stimulator implanted for pain control;

[iv]. employment requirements are outlined. The patients employment requirements should also be discussed as well as the need to drive. It is generally not recommended to allow workers in safety sensitive positions to take opioids. Opioid naïve patients or those changing doses are likely to have decreased driving ability. Some patients on chronic opioids may have nominal interference with driving ability; however, effects are specific to individuals. Providers may choose to order certified driver rehabilitation assessment;

[v]. urine drug screening for substances of abuse and substances currently prescribed. Clinicians should keep in mind that there are an increasing number of deaths due to the toxic misuse of opioids with other medications and alcohol. Drug screening is a mandatory component of chronic opioid management. It is appropriate to screen for alcohol and marijuana use and have a contractual policy regarding both alcohol and marijuana use during chronic opioid management. Alcohol use in combination with opioids is likely to contribute to death;

[vi]. review of the Prescription Monitoring Program. Louisiana Revised Statutes 40:978 and 40:1001-1014. Informed, written, witnessed consent by the patient including the aspects noted above. Patients should also be counseled on safe storage and disposal of opioids;

[vii]. the trial, with a short-acting agent, should document sustained improvement of pain control, at least a 30 percent reduction, and of functional status, including return-to-work, and/or increase in activities of daily living. It is necessary to establish goals which are specific, measurable, achievable, and relevant prior to opioid trial or adjustment to measure changes in activity/function. Measurement of functional goals may include patient completed validated functional tools. Frequent follow-up at least every two to four weeks may be necessary to titrate dosage and assess clinical efficacy.

[c]. On-Going, Long-Term Management after a successful trial should include:

[i]. prescriptions from a single practitioner;

[ii]. ongoing review and documentation of pain relief, functional status, appropriate medication use, and side effects; full review at least every three months;

[iii]. ongoing effort to gain improvement of social and physical function as a result of pain relief;

[iv]. review of the Prescription Monitoring Program (PMP);

[v]. shared decision making agreement detailing the following:

{a}. side effects anticipated from the medication;

{b}. requirement to continue active therapy;

{c}. need to achieve functional goals including return to work for most cases;

{d}. reasons for termination of opioid management, referral to addiction treatment, or for tapering opioids (tapering is usually for use longer than 30 days). Examples to be included in the contract include, but are not limited to:

{i}. diversion of medication;

{ii}. lack of functional effect at higher doses;

{iii}. non-compliance with other drug use;

{iv}. drug screening showing use of drugs outside of the prescribed treatment or evidence of non-compliant use of prescribed medication;

{v}. requests for prescriptions outside of the defined time frames;

{vi}. lack of adherence identified by pill count, excessive sedation, or lack of functional gains

{vii}. excessive dose escalation with no decrease in use of short-term medications;

{viii}. apparent hyperalgesia;

{ix}. shows signs of substance use disorder (including but not limited to work or family problems related to opioid use, difficulty controlling use, craving);

{x}. experiences overdose or other serious adverse event

{xi}. shows warning signs for overdose risk such as confusion, sedation, or slurred speech.

{e}. patient agreements should be written at a sixth grade reading level to accommodate the majority of patients;

{f}. use of random drug screening, initially, four times a year or possibly more with documented suspicion of abuse or diversion or for stabilization or maintenance phase of treatment. In addition to those four or more random urine drug screens, quantitative testing is appropriate in cases of inconsistent findings, suspicions, or for particular medications that patient is utilizing that is not in the qualitative testing.;

{i}. drugs or drug classes for which screening is performed should only reflect those likely to be present based on the patients medical history or current clinical presentation, illicit substances, the practitioners suspicion, and without duplication;

{ii}. qualitative urine drug testing (UDT) (i.e., immunoassay to evaluate, indicates the drug is present) that is utilized for pain management or substance abuse monitoring, may be considered medically necessary for: baseline screening/Induction phase before initiating treatment or at time treatment is initiated, stabilization phase of treatment with targeted weekly qualitative screening for a maximum of four weeks. (This type of monitoring is done to identify those patients who are expected to be on a stable dose of opioid medication within a four-week timeframe.) Maintenance phase of treatment with targeted qualitative screening once every one to three months. Subsequent monitoring phase of treatment at a frequency appropriate for the risk level of the individual patient. (This type of monitoring is done to identify those patients who are noncompliant or abusing prescription drugs or illicit drugs.) Note: In general, qualitative urine drug testing should not require more than four tests in a 12-month period. Additional testing, as listed above, would require clinical justification of medical necessity;

{iii}. quantitative UDT (i.e., gas chromatography and or mass spectrometry [GCMS] as confirmatory, indicates the amount of drug is present) that is utilized for pain management or substance abuse monitoring, may be considered medically necessary under the following circumstances: When immunoassays for the relevant drug(s) are not commercially available, or in specific situations when qualitative urine drug levels are required for clinical decision making. The following qualitative urine drug screen results must be present and documented: Positive for a prescription drug that is not prescribed to the patient; or Negative for a prescription drug that is prescribed to the patient; or Positive for an illicit drug;

{iv}. quantitative testing is not appropriate for every specimen and should not be done routinely. This type of test should be performed in a setting of unexpected results and not on all specimens. The rationale for each quantitative test must be supported by the ordering clinicians documentation. The record must show that an inconsistent positive finding was noted on the qualitative testing or that there was not an available qualitative test to evaluate the presence of semisynthetic or synthetic opioid, illicit drugs or other medications used for pain management in a patient. Simultaneous blood and urine drug screening or testing is not appropriate and should not be done.

{v}. urine testing, when included as one part of a structured program for pain management, has been observed to reduce abuse behaviors in patients with a history of drug misuse. Clinicians should keep in mind that there are an increasing number of deaths due to the toxic misuse of opioids with other medications and alcohol. Drug screening is a mandatory component of chronic opioid management. Clinicians should determine before drug screening how they will use knowledge of marijuana use. It is appropriate to screen for alcohol and marijuana use and have a contractual policy regarding both alcohol and marijuana use during chronic opioid management. Alcohol use in combination with opioids is likely to contribute to death. From a safety standpoint, it is more important to screen for alcohol use than marijuana use as alcohol is more likely to contribute to unintended overdose;

{vi}. physicians should recognize that occasionally patients may use non-prescribed substances because they have not obtained sufficient relief on the prescribed regime.

[vi]. chronic use limited to two oral opioids;

[vii]. transdermal medication use, other than buprenorphine, is generally not recommended;

[viii]. use of acetaminophen-containing medications in patients with liver disease should be limited; including over-the-counter medications. Acetaminophen dose should not exceed 4 grams per day for short-term use or 2 to 3 grams/day for long-term use in healthy patients. A safer chronic dose may be 1800 mg/day;

[ix]. continuing review of overall therapy plan with regard to non-opioid means of pain control and functional status;

[x]. tapering of opioids may be necessary for many reasons including the development of hyperalgesia, decreased effects from an opioid, lack of compliance with the opioid contract, or intolerance of side effects. Some patients appear to experience allodynia or hyperalgesia on chronic opioids. This premise is supported by a study of normal volunteers who received opioid infusions and demonstrated an increase in secondary hyperalgesia. Options for treating hyperalgesia include withdrawing the patient from opioids and reassessing their condition. In some cases, the patient will improve when off of the opioid. In other cases, another opioid may be substituted;

{a}. Tapering may also be appropriate by patient choice, to accommodate "fit-for-duty" demands, prior to major surgery to assist with post-operative pain control, to alleviate the effects of chronic use including hypogonadism, medication side effects, or in the instance of a breach of drug agreement, overdose, other drug use aberrancies, or lack of functional benefit. It is also appropriate for any of the tapering criteria listed in Section E above.

{b}. Generally tapering can be accomplished by decreasing the dose 10 percent per week. This will generally take 6 to 12 weeks and may need to be done one drug class at a time. Behavioral support is required during this service. Tapering may occur prior to MMI or in some cases during maintenance treatment.

[xi]. medication assisted treatment with buprenorphine or methadone may be considered for opioid abuse disorder, in addition to behavioral therapy;

[xii]. inpatient treatment may be required for addiction or opioid tapering in complex cases. Refer to Interdisciplinary Rehabilitation Programs for detailed information on inpatient criteria;

[d]. Relative Contraindications-Extreme caution should be used in prescribing controlled substances for workers with one or more "relative contraindications": Consultation with a pain or addiction specialist may be useful in these cases;

[i]. history of alcohol or other substance abuse, or a history of chronic, benzodiazepine use;

[ii]. sleep apnea: If patient has symptoms of sleep apnea, diagnostic tests should be pursued prior to chronic opioid use;

[iii]. off work for more than six months with minimal improvement in function from other active therapy;

[iv]. severe personality disorder or other known severe psychiatric disease per psychiatrist or psychologist;

[v]. monitoring of behavior for signs of possible substance abuse indicating an increased risk for addiction and possible need for consultation with an addiction specialist.

[e]. High Risk Behavior: The following are high risk warning signs for possible drug abuse or addiction. Patients with these findings may need a consultation by a physician experienced in pain management and/or addiction. Behaviors in the first list are warning signs, not automatic grounds for dismissal, and should be followed up by a reevaluation with the provider.

[i]. repeated behaviors in the first list may be more indicative of addiction and behaviors in the second list should be followed by a substance abuse evaluation:

{a}. First List: Less suggestive for addiction but are increased in depressed patients- Frequent requests for early refills; claiming lost or stolen prescriptions; Opioid(s) used more frequently, or at higher doses than prescribed; Using opioids to treat non-pain symptoms; Borrowing or hoarding opioids; Using alcohol or tobacco to relieve pain; Requesting more or specific opioids; Recurring emergency room visits for pain; Concerns expressed by family member(s); Unexpected drug test results; Inconsistencies in the patients history.

{b}. Second List: More suggestive of addiction and are more prevalent in patients with substance use disorder- Buying opioids on the street; stealing or selling drugs; Multiple prescribers ("doctor shopping"); Trading sex for opioids; Using illicit drugs; Positive urine drug tests for illicit drugs; Forging prescriptions; Aggressive demands for opioids; Injecting oral/topical opioids; Signs of intoxication (ETOH odor, sedation, slurred speech, motor instability, etc.).

[ii]. both daily and monthly users of nicotine were at least three times more likely to report non-medical use of opioid in the prior year. At least one study has demonstrated a prevalence of smokers and former smokers among those using opioids and at higher doses compared to the general population. It also appeared that smokers and former smokers used opioids more frequently and in higher doses than never smokers. Thus, tobacco use history may be a helpful prognosticator;

[iii]. in one study, four specific behaviors appeared to identify patients at risk for current substance abuse: increasing doses on their own, feeling intoxicated, early refills, and oversedating oneself. A positive test for cocaine also appeared to be related;

[iv]. one study found that half of patients receiving 90 days of continuous opioids remained on opioids several years later and that factors associated with continual use included daily opioid greater than 120 MED prior opioid exposure, and likely opioid misuse;

[v]. One study suggested that those scoring at higher risk on the screener and opioid assessment for patients with pain-revised (SOAPP-R), also had greater reductions in sensory low back pain and a greater desire to take morphine. It is unclear how this should be viewed in practice.

[f]. Dosing and Time to Therapeutic Effect. Oral route is the preferred route of analgesic administration because it is the most convenient and cost-effective method of administration. Transbuccal administration should be avoided other than for buprenorphine. A daily dosage above 50 MED may be appropriate for certain patients. However, when the patients dosage exceeds 50 MED per day and/or the patient is sedentary with minimal function, consideration should be given to lowering the dosage. Some patients may require dosages above 90 MED per day. However, if the patient reaches a dosage above 90 MED per day, it is appropriate to taper or refer to a pain or addiction specialist. The provider should also adhere to all requirements in this guideline and closely monitor the patient as this is considered a high risk dosage. In some cases, buprenorphine may be a preferred medication for pain control in those patients. Consultation may be necessary.

[g]. Major Side Effects-There is great individual variation in susceptibility to opioid-induced side effects and clinicians should monitor for these potential side effects. Common initial side effects include nausea, vomiting, drowsiness, unsteadiness, and confusion. Occasional side effects include dry mouth, sweating, pruritus, hallucinations, and myoclonus. Rare side effects include respiratory depression and psychological dependence. Constipation and nausea/vomiting are common problems associated with long-term opioid administration and should be anticipated, treated prophylactically, and monitored constantly. Stool softeners, laxatives, and increased dietary fluid may be prescribed. Refer to Section G.10.g, Opioid Induced Constipation. Chronic sustained release opioid use is associated with decreased testosterone in males and females and estradiol in pre-menopausal females. Patients should be asked about changes in libido, sexual function, and fatigue. Appropriate lab testing and replacement treatment should be completed.

[h]. Naloxone or oral and injection Naltrexone: may be prescribed when any risk factors are present. The correct use of Naloxone and Naltrexone should be discussed with the patient and family.

[i]. Benzodiazepines: should not be prescribed when opioids are used.

[j]. Sedation: Driving and Other Tasks. Although some studies have shown that patients on chronic opioids do not function worse than patients not on medication, caution should be exerted, and patients should be counseled never to mix opioids with the use of alcohol or other sedating medication. When medication is increased or trials are begun, patients should not drive for at least five days. Chronic untreated pain, sedatives especially when mixed with opiates or alcohol, and disordered sleep can also impair driving abilities.

[k]. Drug Interactions. Patients receiving opioid agonists should not be given a mixed agonist-antagonist such as pentazocine [Talacen, Talwin] or butorphanol [Stadol] because doing so may precipitate a withdrawal syndrome and increase pain.

[i]. All sedating medication, especially benzodiazepines, should be avoided or limited to very low doses. Over-the-counter medications such as antihistamines, diphenhydramine, and prescription medications such as hydroxyzine (Anx, Atarax, Atazine, Hypam, Rezine, Vistaril) should be avoided except when being used to manage withdrawal during tapering of opioids. Alcohol should not be used.

[l]. Recommended Laboratory Monitoring. Primary laboratory monitoring is recommended for acetaminophen/aspirin/ibuprofen combinations (renal and liver function, blood dyscrasias) although combination opioids are not recommended for long-term use. Morphine and other medication may require renal testing and other screening. A comprehensive genetic testing panel may be ordered by treating physician for these multiple P450 genes once in a lifetime and utilized whenever there is a question of metabolism or unusual response of any drugs used to treat pain conditions, because multiple drugs and associated genes can cause problems with opioid metabolism.

[m]. Sleep Apnea Testing: Both obstructive and central sleep apnea are likely to be exaggerated by opioid use or may occur secondary to higher dose chronic opioid use and combination medication use, especially benzodiazepines and sedative hypnotics. Patients should be questioned about sleep disturbance and family members or sleeping partners questioned about loud snoring or gasping during sleep. If present, qualified sleep studies and sleep medicine consultation should be obtained. Portable sleep monitoring units are generally not acceptable for diagnosing primary central sleep apnea. Type 3 portable units with two airflow samples and an 02 saturation device may be useful for monitoring respiratory depression secondary to opioids, although there are no studies on this topic.

[n]. Regular consultation of the Prescription Monitoring Program (PMP). Physicians should review their patients on the system whenever drug screens are done. This information should be used in combination with the drug screening results, functional status of the patient, and other laboratory findings to review the need for treatment and level of treatment appropriate for the patient.

[o]. Addiction. If addiction occurs, patients will require treatment. Refer to Section G.12, Opioid Addiction Treatment. After detoxification, they may need long-term treatment with naltrexone (Depade, ReVia, Vivitrol), an antagonist which can be administered in a long-acting form or buprenorphine which requires specific education per the Drug Enforcement Agency (DEA).

[p]. Potentiating Agents. There is some evidence that dextromethorphan does not potentiate the effect of morphine opioids and therefore is not recommended to be used with opioids.

v. Topical Drug Delivery:

(a). Description. Topical medications, such as ketamine and capsacin, may be an alternative treatment for neuropathic disorders and is an acceptable form of treatment in selected patients although there is no literature addressing its use in patients with CRPS.

(b). Indications. Pain. Patient selection must be rigorous to select those patients with the highest probability of compliance.

(c). Dosing and Time to Therapeutic Effect. It is necessary that all topical agents be used with strict instructions for application as well as maximum number of applications per day to obtain the desired benefit and avoid potential toxicity.

(d). Side Effects. Localized skin reactions may occur, depending on drug.

vi. Other Agents

(a). Agents not listed which may be useful in the treatment of CRPS and SMP include propranolol, nifedipine, calcitonin, bisphosphonates and short-term oral steroids, during the acute phase of the disease. Although propranolol, nifedipine, oral steroids, and calcitonin are used in practice, at this time there is a lack of well-designed studies to support their effectiveness compared to placebo. In individual patients, they may be effective. There is some evidence to support the use of intravenous bisphosphonate drugs, currently licensed for use in malignant bone disease and Paget's disease, in CRPS patients with abnormal bone scans. Oral use of bisphosphonates has not been studied in CRPS.

7. Orthotics/prosthetics/equipment. Devices and adaptive equipment may be necessary in order to reduce impairment and disability, to facilitate medical recovery, to avoid re-aggravation of the injury, and to maintain maximum medical improvement. Refer to the Chronic Pain Medical Treatment Guidelines for detailed information on Orthotics/Prosthetics/Equipment.

8. Patient education. Patients should be educated on their specific injury, assessment findings, and plan of treatment and encouraged to take an active role in establishing functional outcome goals. No treatment plan is complete without addressing issues of individual and/or group patient education as a means of prolonging the beneficial effects of rehabilitation, as well as facilitating self-management of symptoms and prevention of secondary disability. There is good evidence that patient education in self-management of asthma, anticoagulation, and other diseases improves appropriate use of medications, increases patient satisfaction with care, and reduces unscheduled physician visits for dealing with complications of treatment.

a. Patient education is an interactive process that provides an environment where the patient not only acquires knowledge but also gains an understanding of the application of that knowledge. Therefore, patients should be able to describe and/or will need to be educated on:

i. The treatment plan.

ii. Indications for and potential side effects of medications.

iii. Their home exercise program.

iv. Expected results of treatment.

v. Tests to be performed, the reasons for them and their results.

vi. Activity restrictions and return-to-work status.

vii. Home management for exacerbations of pain.

viii. Procedures for seeking care for exacerbations after office hours.

ix. Home self-maintenance program.

x. Patient responsibility to communicate with all medical providers and the employer; and

xi. Patient responsibility to keep appointments.

b. Educational efforts should also extend to family and other support persons, the case manager, the insurer and the employer as indicated to optimize the understanding of the patient and the outcome. Professional translators should be provided for non-English speaking patients to assure optimum communication. All education, teaching, and instruction given to the patient should be documented in the medical record.

c. Effects of education weaken over time; continuing patient education sessions will be required to maximize the patient's function. The effectiveness of educational efforts can be enhanced through attention to the learning style and receptivity of the patient. Written educational materials may reinforce and prolong the impact of verbal educational efforts. Overall, patient education should emphasize health and wellness, return to work and return to a productive life.

i. Time to produce effect: Varies with individual patient

ii. Frequency: At each visit

9. Personality/psychological/psychiatric/ psychosocial intervention. Psychosocial treatment is generally accepted, well-established therapeutic and diagnostic procedure with selected use in acute pain problems, but with more widespread use in sub-acute and chronic pain populations. Psychosocial treatment is recommended as an important component in the total management of a patient with chronic pain and should be implemented as soon as the problem is identified.

a. Once a diagnosis consistent with the standards of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM) has been determined, the patient should be evaluated for the potential need for psychiatric medications. Use of any medication to treat a diagnosed condition may be ordered by the authorized treating physician or by the consulting psychiatrist and/or medical psychologists. Visits for management of psychiatric medications are medical in nature and are not a component of psychosocial treatment. Therefore, separate visits for medication management may be necessary, depending upon the patient and medications selected.

b. The screening or diagnostic workup should have clarified and distinguished between preexisting, aggravated, and or purely causative psychological conditions. Therapeutic and diagnostic modalities include, but are not limited to, individual counseling, and group therapy. Treatment can occur within an individualized model, a multi-disciplinary model, or within a structured pain management program.

c. Refer to Chronic Pain guideline for detailed information on whom may perform the service and timeframe parameters.

10. Restriction of activities. Continuation of normal daily activities is the recommendation for chronic pain patients since immobility will negatively affect rehabilitation. Prolonged immobility results in a wide range of deleterious effects, such as a reduction in aerobic capacity and conditioning, loss of muscle strength and flexibility, increased segmental stiffness, promotion of bone demineralization, impaired disc nutrition, and the facilitation of the illness role.

a. Patients should be educated to the detrimental effects of immobility versus the efficacious use of rest periods. Adequate rest allows the patient to comply with active treatment and benefit from the rehabilitation program. In addition, complete work cessation should be avoided, if possible, since it often further aggravates the pain presentation and promotes disability. Modified return to work is almost always more efficacious and rarely contraindicated in the vast majority of injured workers with chronic pain.

11. Return-to-work is one of the major components in chronic pain management. Return to work is a subject that should be addressed by each workers' compensation provider at the first meeting with the injured employee, and be updated at each additional visit. A return to work format should be part of a company's health plan, knowing that return to work can decrease anxiety, reduce the possibility of depression, and reconnect the worker with society.

a. Because a prolonged period of time off work will decrease the likelihood of return to work, the first weeks of treatment are crucial in preventing and/or reversing chronicity and disability mindset. In complex cases, experienced nurse case managers may be required to assist in return to work. Other services, including psychological evaluation and/or treatment and vocational assistance should be employed.

b. The following should be considered when attempting to return an injured worker with chronic pain to work.

i. Job History Interview. The authorized treating physician should perform a job history interview at the time of the initial evaluation and before any plan of treatment is established. Documentation should include the workers' job demands, stressors, duties of current job, and duties of job at the time of the initial injury. In addition, cognitive and social issues should be identified and treatment of these issues should be incorporated into the plan of care.

ii. Coordination of Care. Management of the case is a significant part of return to work and may be the responsibility of the authorized treating physician, occupational health nurse, risk manager, or others. Case management is a method of communication between the primary provider, referral providers, insurer, employer and employee. Because case management may be coordinated by a variety of professionals, the case manager should be identified in the medical record.

iii. Communication is essential between the patient, authorized treating physician, employer and insurer. Employers should be contacted to verify employment status, job duties and demands, and policies regarding injured workers. In addition, availability of temporary and permanent restrictions, for what duration, as well as other placement options should be discussed and documented.

iv. Establishment of a Return-To-Work Status. Return to work for persons with chronic pain should be thought of as therapeutic, assuming that work is not likely to aggravate the basic problem or increase the discomfort. In most cases of chronic pain, the worker may not be currently working or even employed. The goal of return to work would be to implement a plan of care to return the worker to any level of employment with the current employer or to return them to any type of new employment.

v. Establishment of Activity Level Restrictions. A formal job description for the injured/ill employee who is employed is necessary to identify physical demands at work and assist in the creation of modified duty. A jobsite evaluation may be utilized to identify tasks such as pushing, pulling, lifting, reaching above shoulder level, grasping, pinching, sitting, standing, posture, ambulatory distance and terrain, and if applicable, environment for temperature, air flow, noise and the number of hours that may be worked per day. Work restrictions assigned by the authorized treating physician may be temporary or permanent. The case manager should continue to seek out modified work until restrictions become less cumbersome or as the worker's condition improves or deteriorates.

vi. Rehabilitation and Return to Work. As part of rehabilitation, every attempt should be made to simulate work activities so that the authorized treating physician may promote adequate job performance. The use of ergonomic or adaptive equipment, therapeutic breaks, and interventional modalities at work may be necessary to maintain employment.

vii. Vocational Assistance. Formal vocational assistance is a generally accepted intervention and can assist disabled persons to return to viable employment. Assisting patients to identify vocational goals will facilitate medical recovery and aid in the maintenance of MMI by increasing motivation towards treatment and alleviating the patients emotional distress. Chronic pain patients may benefit most if vocational assistance is provided during the interdisciplinary rehabilitation phase of treatment. To assess the patients vocational capacity, a vocational assessment may be utilized to identify rehabilitation program goals, as well as optimize both patient motivation and utilization of rehabilitation resources.

(a). Employers and employees of small businesses who are diagnosed with chronic pain may not be able to perform any jobs for which openings exist. Temporary employees may fill those slots while the employee functionally improves. Some small businesses hire other workers and if the injured employee returns to the job, the supervisor/owner may have an extra employee. To avoid this, it is suggested that case managers be accessed through their insurer or third party insurers. Case managers may assist with resolution of these problems, as well as assist in finding modified job tasks, or find jobs with reduced hours, etc., depending upon company philosophy and employee needs.

(b). Employers and employees of mid-sized and large businesses are encouraged by the OWCA to identify modified work within the company that may be available to injured workers with chronic pain who are returning to work with temporary or permanent restrictions. To assist with temporary or permanent placement of the injured worker, it is suggested that a program be implemented that allows the case manager to access descriptions of all jobs within the organization.

12. Therapy - active is based on the philosophy that therapeutic exercise and/or activity are beneficial for restoring flexibility, strength, endurance, function, range of motion, and can alleviate discomfort.

a. Active therapy requires an internal effort by the individual to complete a specific exercise or task. This form of therapy requires supervision from a therapist or medical provider such as verbal, visual and/or tactile instruction(s). Active therapy is intended to promote independence and self-reliance in managing the physical pain as well as to improve the functional status in regard to the specific diagnosis and general conditioning and well-being. At times, a provider may help stabilize the patient or guide the movement pattern but the energy required to complete the task is predominately executed by the patient.

b. Patients should be instructed to continue active therapies at home as an extension of the treatment process in order to maintain improvement levels. Home exercise can include exercise with or without mechanical assistance or resistance and functional activities with assistive devices.

c. Since CRPS and SMP patients frequently have additional myofascial pain generators, other active therapies not listed may be used in treatment. Refer to the Chronic Pain Medical Treatment Guideline for therapies and timeframe parameters not listed. The following active therapies are listed in alphabetical order:

i. Activities of Daily Living (ADL) Activities of daily living are instruction, active-assisted training, and/or adaptation of activities or equipment to improve a person's capacity in normal daily activities such as self-care, work re-integration training, homemaking and driving.

(a). Time to produce effect: four to five treatments

(b). Frequency: three to five times per week

(c). Optimum duration: four to six weeks

(d). Maximum duration: six weeks

ii. Aquatic Therapy is the implementation of active therapeutic procedures (individual or group) in a swimming or therapeutic pool heated to 88-92 degrees. The water provides a buoyancy force that lessens the amount of force gravity applies to the body, and the pool should be large enough to allow full extremity range of motion and full erect posture. The decreased gravity effect allows the patient to have a mechanical advantage increases the likelihood of successful therapeutic exercise. Multiple limb involvement, weight bearing problems, and vasomotor abnormalities are frequently treated with water exercise. Indications for individuals who may not tolerate active land-based or full weight bearing therapeutic procedures or who require augmentation or other therapy. Aquatic vests, belts and other devices can be used to provide stability, balance, buoyancy, and resistance.

(a). Time to produce effect: 5 to 10 sessions

(b). Frequency: one to three times per week

(c). Optimum duration: four to six weeks

(d). Maximum duration: Six weeks. Multiple limb involvement may require longer intervention.

iii. Gait Training. Indications include the need to promote normal gait pattern with assistive devices and/or to reduce risk of fall or loss of balance. This may include instruction in safety and proper use of assistive devices and gait instruction on uneven surfaces and steps (with or without railings).

(a). Time to produce effect: one to six sessions

(b). Frequency: one to three times per week

(c). Optimum duration: two weeks. Could be needed intermittently as changes in functional status occur.

(d). Maximum duration: one month.

iv. Neuromuscular Re-education is the skilled application of exercise with manual, mechanical, or electrical facilitation to enhance strength, movement patterns, neuromuscular response, proprioception, kinesthetic sense, coordination, education of movement, balance, and posture. Indications include the need to promote neuromuscular responses through carefully timed proprioceptive stimuli, to elicit and improve motor activity in patterns similar to normal neurologically developed sequences, and improve neuromotor response with independent control.

(a). Time to produce effect: six treatments

(b). Frequency: one to three times per week

(c). Optimum duration: four to eight weeks

(d). Maximum Duration: 8 to 12 weeks

v. Stress Loading is considered a reflex and sensory integration technique involving the application of a compressive load and a carry load. It is carried out in a consistent, progressive manner and integrated as part of a home program. Use of this technique may increase symptoms initially, but symptoms generally subside with program consistency.

(a). Time to produce effect: three weeks

(b). Frequency: two to three times per week.

(c). Optimum duration: Four to six weeks and concurrent with an active daily home exercise program.

(d). Maximum Duration: 6 to 10 weeks

vi. Therapeutic exercise with or without mechanical assistance or resistance, may include isoinertial, isotonic, isometric and isokinetic types of exercises. Stress loading exercises are recommended. Indications include the need for cardiovascular fitness, reduced edema, improved muscle strength, improved connective tissue strength and integrity, increased bone density, promotion of circulation to enhance soft tissue healing, improvement of muscle recruitment, increased range of motion and are used to promote normal movement patterns. This can also include, alternative/complementary exercise movement therapy. Therapeutic exercise programs should be tissue specific to the injury and address general functional deficits as identified in the diagnosis and clinical assessment. Patients should be instructed in and receive a home exercise program that progresses as their functional status improves. Upon discharge, the patient would be independent in the performance of the home exercise program and would have been educated in the importance of continuing such a program. Educational goals would be to maintain or further improve function and to minimize the risk for aggravation of symptoms in the future.

(a). Time to produce effect: three weeks

(b). Frequency: one to three times per week

(c). Optimum duration: Four to eight weeks and concurrent with an active daily home exercise program.

(d). Maximum Duration: 8 to 12 weeks of therapist oversight. Home exercise should continue indefinitely.

13. Therapy - passive. Most of the following passive therapies and modalities are generally accepted methods of care for a variety of work-related injuries. Passive therapy includes those treatment modalities that do not require energy expenditure on the part of the patient. They are principally effective during the early phases of treatment and are directed at controlling symptoms such as pain, inflammation and swelling and to improve the rate of healing soft tissue injuries. They should be used adjunctively with active therapies to help control swelling, pain and inflammation during the rehabilitation process. They may be used intermittently as a therapist deems appropriate, or regularly if there are specific goals with objectively measured functional improvements during treatment.

a. Factors such as exacerbation of symptoms, re-injury, interrupted continuity of care, and co-morbidities may extend durations of care. Having specific goals with objectively measured functional improvement during treatment can support extended durations of care. It is recommended that if after 6 to 8 visits no treatment effect is observed, alternative treatment interventions, further diagnostic studies or further consultations should be pursued.

b. Since CRPS and SMP patients frequently have additional myofascial pain generators, other passive therapies not listed may be used in treatment. Refer to the Chronic Pain Disorder Medical Treatment Guideline's for therapies and timeframe parameters not listed. The following passive therapies are listed in alphabetical order:

i. Continuous Passive Motion (CPM): is rarely indicated in CRPS but may occasionally be warranted if the patient shows signs of contracture despite active therapy.

(a). Time to produce effect: Four to six treatments

(b). Frequency: Varies, between two to three times per day and one time per week.

(c). Optimum duration: Four treatments

(d). Maximum duration: Six treatments. Provide home unit with improvement.

ii. Fluidotherapy. Used primarily for desensitization and to facilitate increased active range of motion. Thermal heat conduction and convection is advantageous for vasodilation, muscle relaxation, and preparation for stress and activity (exercise).

(a). Time to produce effect: Three treatments

(b). Frequency: Three times per week

(c). Optimum duration: Two months

(d). Maximum duration: Two months as a primary therapy or intermittently as an adjunct therapy to other procedures.

iii. Orthotics/Splinting. Static splinting is discouraged. Dynamic splinting may occasionally be useful in controlling proximal hypertonicity or for other concurrent pain generators.

(a). Time to produce effect: One week

(b). Frequency: varies depending upon application

(c). Optimum duration: One month

(d). Maximum duration: Two months

iv. Paraffin Bath. Indications include the need to enhance collagen extensibility before stretching, reduce muscle guarding, and to prepare for functional restoration activities.

(a). Time to produce effect: One to two treatments

(b). Frequency: One to three times per week as an adjunct treatment to other procedures. May use daily if available at home

(c). Optimum duration: Two weeks

(d). Maximum duration: Three to four weeks. If effective, purchase home unit.

v. Desensitization is accomplished through sensory integration techniques. Concurrent desensitization techniques are generally accepted as a treatment for CRPS. Home techniques using soft cloths of various textures, massage, and vibrators may be beneficial in reducing allodynia and similar sensory abnormalities.

(a). Time to produce effect: Six treatments

(b). Frequency: Three times per week and concurrent with home exercise program

(c). Optimum duration: Three weeks with reinforcement of home program

(d). Maximum duration: One month.

vi. Superficial Heat Therapy. Superficial heat is a thermal agent applied to raise the body tissue temperature. It is indicated before exercise to elevate the pain threshold, alleviate muscle spasm, and promote increased movement. Heat packs can be used at home as an extension of therapy in the clinic setting.

(a). Time to produce effect: Immediate

(b). Frequency: One to three times per week

(c). Optimum duration: Two weeks as primary or intermittently as an adjunct to other therapeutic procedures.

(d). Maximum duration: Two weeks. Home use as a primary modality may continue at the providers' discretion.

La. Admin. Code tit. 40, § I-2131

Promulgated by the Louisiana Workforce Commission, Office of Workers Compensation Administration, LR 37:1723 (June 2011), Amended LR 46254 (2/1/2020).

AUTHORITY NOTE: Promulgated in accordance with R.S. 23:1203.1.