Code of Colorado Regulations
1100 - Department of Labor and Employment
1101 - Division of Workers' Compensation
7 CCR 1101-3 R17 Ex 07 - Rule 17, Exhibit 7 - COMPLEX REGIONAL PAIN SYNDROME/REFLEX SYMPATHETIC DYSTROPHY MEDICAL TREATMENT GUIDELINES

* Consensus means the judgment of experienced professionals based on general medical principles. Consensus recommendations are designated in the guidelines as "generally well-accepted," "generally accepted," "acceptable/accepted," or "well-established."

* "Some evidence" means the recommendation considered at least one adequate scientific study, which reported that a treatment was effective. The Division recognizes that further research is likely to have an impact on the intervention's effect.

* "Good evidence" means the recommendation considered the availability of multiple adequate scientific studies or at least one relevant high-quality scientific study, which reported that a treatment was effective. The Division recognizes that further research may have an impact on the intervention's effect.

* "Strong evidence" means the recommendation considered the availability of multiple relevant and high-quality scientific studies, which arrived at similar conclusions about the effectiveness of a treatment. The Division recognizes that further research is unlikely to have an important impact on the intervention's effect.

All recommendations in the guideline are considered to represent reasonable care in appropriately selected cases, irrespective of the level of evidence or consensus statement attached to them. Those procedures considered inappropriate, unreasonable, or unnecessary are designated in the guideline as "not recommended."

Please refer to the Colorado Department of Labor and Employment's website for evidence tables and study critiques which provide details on the studies used to develop the evidence statements.

Mechanical Allodynia: refers to the abnormal perception of pain from usually non-painful mechanical stimulation.

Static Mechanical Allodynia: refers to pain obtained by applying a single stimulus such as light pressure to a defined area.

Dynamic Mechanical Allodynia: obtained by moving the stimulus such as a brush or cotton tip across the abnormal hypersensitive area.

Thermal Allodynia: refers to the abnormal sensation of pain from usually non-painful thermal stimulation such as cold or warmth.

Clinical criteria alone are not dependable nor necessarily reliable and require objective testing. One study of interrater reliability for diagnosing CRPS I showed poor reliability for assessment of temperature difference and color difference between the affected limbs. Two other studies compared physician's assessment with actual measured signs of CRPS I. The first study advocated bedside use of infrared thermometer and volume measurements. The study found a volume difference between the hands of 30.4 cc and a dorsal hand temperature difference of at least 0.78°C could be used to help establish the diagnosis. The study also noted frequent decreased mobility in the little finger. This study only included patients known to have CRPS; thus, agreement between the objective measurements and the physicians' observations was good. The second study compared physicians' clinical assessments with measured objective results and found that the clinical establishment of temperature and volume asymmetry was inadequate. It also noted poor to moderate correspondence between patient reported severity of symptoms and the physicians' clinical judgment and actual measurements.

A separate study used skin surface temperature to differentiate between CRPS in patients after a fracture and control patients with other complaints following a fracture. This study also incorporated a control group of healthy patients without complaints. Notably there was significantly more asymmetry between the temperature findings in the CRPS group than in both the control groups, with and without complaints. However, the control group with complaints had greater temperature differences than the otherwise healthy group. The study concluded that the ability of skin surface temperatures under resting conditions to discriminate between CRPS patients and other patients is limited. Historically some authors have used 2°C as a limit for temperature differences and others have used lower cutoffs. This study also applied various temperature asymmetry cut offs and could identify no specific combination resulting in sufficient predictive power. However, the negative predictive power was 84% for resting temperature asymmetry less than 0.7°C. This would seem to suggest that it is unlikely a patient has CRPS if they do not have resting temperature asymmetry; however, resting temperature asymmetry differences may be due to a variety of reasons other than CRPS.

Several studies have assessed skin temperature changes in variable settings. In one study skin temperature measurements were recorded over 5-8 hours and the instruments were able to compare the difference between the limbs with every day activities. Twenty-two patients with CRPS, 18 with limb pain of other origin, and 22 of healthy controls were compared. Examining the asymmetry throughout the time period, a difference of 2°C could differentiate CRPS from patients with other painful disease with specificity of 67% and 79% versus healthy controls. It was noted many patients in all groups had a 2°C difference between the limbs at one time or another. However, the persistence of the difference and the asymmetry was important in the diagnosis. The difference between the limbs could occur in either direction, warmer or cooler, than the unaffected side.

Thermographic imaging has been done in two studies using whole body warming and cooling. The initial study established the fact that in CRPS patients the temperature difference between hands increases significantly when the sympathetic system is provoked with whole body temperature changes. A separate more detailed study induced whole body warming and cooling and compared temperature and blood flow in three sets of patients, one with CRPS, one with patients of extremity pain of other origins, and a third group of healthy volunteers. None of the participants were on medications affecting vascular functions. Three patterns of temperature change were noted for CRPS patients. In some patients with "warm" CRPS, the temperature continually exceeded the temperature of the unaffected limb during the cooling and warming period. In others, where the affected limb was cooler than the unaffected limb, the affected limb may have remained cooler throughout the cooling and warming period. Finally, in a few patients, there was an unusual crossover where initially the patient had a warm or cooler limb compared to the unaffected side and later the affected limb showed temperature differences in the opposite direction. All of these patterns demonstrate an autonomic asymmetry that was not found in healthy volunteers whose limbs temperatures adjust in a symmetrical manner. Previous tests comparing Laser Doppler flow of extremities in healthy controls and patients with distal radius fracture to CRPS I patients showed significant sympathetic changes after contralateral cold exposure. Another study of patients with radius fractures found that non-stress thermography had a sensitivity of 58% and specificity of 66%. Thus, the asymmetry of limb temperature under stress appears to be the most important factor. In this study, the temperature differences needed to exceed 2.2°C to distinguish between the groups.

Another study reviewed skin temperature from thermography, thermoregulatory sweat tests (TST), and quantitative sudomotor axon reflex test (QSART), early and late in patients with clinically diagnosed CRPS. In this study, the differences identified with TST persisted during later testing while QSART differences did not. Skin temperature was asymmetrical between the limbs early and late, although generally in opposite directions. This study describes the dynamic nature of CRPS.

These studies appear to confirm the fact that causing an objectively measured, sympathetically evoked response is likely to be more predictive of CRPS than merely resting temperature differences or resting sudomotor/sweating differences. Temperature testing at any one point in time is probably not sensitive and able to distinguish between patients with pain complaints and those with CRPS. Other review articles have made similar observations regarding the need for dynamic testing.

There is good evidence that CRPS is characterized by inhibition of sympathetic cutaneous responses on the affected side and by blunted sympathetic response to physiologic stimuli. Based on the relatively common finding of temperature discrepancy in non-CRPS patients with chronic pain, a stress test thermogram should be used. Unfortunately, only two studies have been published in this area and neither used a blinded control for comparison. The most commonly reported stress tests consist of contralateral extremity cooling or whole body suit. However, the physiology behind the stress thermography testing is convincing given the prior studies.

In a similar manner, the QSART provides an autonomic stress that is measurable. Perhaps the main issue with the sudomotor test in isolation is that it appears some CRPS patients do not have an abnormal sweat test. To verify the diagnosis, all of these test results need to be compared to other test results, physical exam findings, and symptoms.

Thermal quantitative sensory testing has been used to study neuropathic conditions and CRPS. Components of the test include identification of light touch, warmth, cold, and pain with pressure, cold or heat. The testing relies on patient response to various recordable levels of testing in these areas. Generally, CRPS patients appear to demonstrate hypoalgesia in both the affected and unaffected limbs when compared to normals; hyperalgesia to thermal pain generators and hyperalgesia to blunt pressure. Findings on the specific TST test components differ according to the CRPS classification of warm or cold. There is also some overlap of findings with other neuropathic conditions. In addition, patient response testing can be problematic in a medical legal setting. Thus, more objective tests are used for confirmation of CRPS. Routine clinical exam techniques should be used to evaluate the patient for hyper- and hypoalgesia and allodynia.

Significant harm can be done to individuals by over-diagnosing CRPS and subjecting patients to the side effects and potential morbidity of multiple sympathetic blocks, invasive procedures, or chronic medications, as well as psychological effects from the diagnosis. In order to safe guard against such harmful outcomes, patients should have objective testing to verify their diagnosis before such procedures are considered and/or are continued after the initial diagnosis. Several reviews on the subject have identified the need for more objective measurements. Therefore, individuals must have a confirmed diagnosis of CRPS to receive these procedures.

Patient must meet the criteria below.

Both CRPS I and II confirmed diagnoses require the same elements. CRPS II is distinguished from CRPS I by the history of a specific peripheral nerve injury as the inciting event.

Patient must meet the below criteria:

Description: Diagnostic sympathetic injections are generally accepted procedures to aid in the diagnosis of CRPS I & II and SMP. Sympathetic blocks lack specificity for CRPS I & II. Each diagnostic injection has inherent risk and risk versus benefit should always be evaluated when considering injection therapy. Since these procedures are invasive, less invasive or non-invasive procedures should be considered first. Selection of patients, choice of procedure, and localization of the level for injection should be determined by clinical information.

Special Considerations: Injections with local anesthetics of differing duration are required to confirm a diagnosis. In some cases, injections at multiple levels may be required to accurately diagnose pain. Refer to Section H.6, Injections - Therapeutic, for information on specific injections.

Since fluoroscopic and/or CT guidance during procedures is recommended to document technique and needle placement, an experienced physician should perform the procedure. In addition, physicians should obtain fluoroscopy training and must also have the appropriate training in radiation safety, usually overseen by a radiation safety officer.

Complications: 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 neurological damage.

Contraindications: Absolute contraindications of diagnostic injections include:

Relative Contraindications: Relative contraindications of these injections may include:

Description: There is good evidence that CRPS is characterized by inhibition of sympathetic cutaneous responses on the affected side and by blunted sympathetic response to physiologic stimuli. Based on the relatively common finding of temperature discrepancy in non-CRPS patients with chronic pain, a stress test thermogram should be used. Infrared thermography may be useful for patients with suspected CRPS I and II and SMP. Thermography can distinguish abnormal thermal asymmetry of 1.0°C which is not distinguishable upon physical examination. It may also be useful in cases, to differentiate, of suspected small caliber fiber neuropathy and to evaluate patient response to sympatholytic interventions.

Special Considerations: The practitioner who supervises and interprets the thermographic evaluation shall follow recognized protocols and be board certified by one of the examining boards of the American Academy of Medical Infrared Imaging, American Academy of Thermology, or American Chiropractic College of Thermology, or have equivalent documented training.

Medications with anticholinergic activity (tricyclics, cyclobenzaprine, antiemetics, antipsychotics) may interfere with autonomic testing. The pre-testing protocol which includes cessation of specific medication therapy must be followed for accurate test results. Results of autonomic testing may be affected by peripheral polyneuropathy, radiculopathy or peripheral nerve injury, peripheral vascular disease, generalized autonomic failure, or by Shy-Drager syndrome.

Thermographic Tests: Functional autonomic stress testing may include the following methods:

Description: Resting skin temperature (RST), resting sweat output (RSO), and quantitative sudomotor axon reflex test (QSART) are a generally accepted test battery. There is good evidence that CRPS is characterized by inhibition of sympathetic cutaneous responses on the affected side and by blunted sympathetic response to physiologic stimuli. The tests can provide additional information regarding malfunction of the sympathetic system and the diagnosis of CRPS. Prior authorization is required. As with all diagnostic testing, the results must be interpreted in relationship to the patient's signs and symptoms.

Special Considerations: Medications with anticholinergic activity (tricyclics, cyclobenzaprine, antiemetics, anti-psychotics) may interfere with autonomic testing. Results of autonomic testing may be affected by peripheral polyneuropathy, radiculopathy or peripheral nerve injury, peripheral vascular disease, generalized autonomic failure, or by Shy-Drager syndrome.

Test Battery: These tests measure asymmetries in physiologic manifestations of autonomic activity between an affected limb and an unaffected contralateral limb. Skin temperature reflects vasomotor activity and sweat output measures sudomotor activity. The results of the three test components must be combined and scored. The battery of tests must include a measurement of each component (RST, RSO, and QSART).

Refer to the Division's Chronic Pain Disorder Medical Treatment Guideline for more information on clinical evaluation, a list and description of psychological functioning tests, and evidence.

Refer to the Division's Chronic Pain Disorder Medical Treatment Guideline for indications, evidence, and time frames for the following procedures: computer-enhanced evaluations, functional capacity evaluations, jobsite evaluations and alterations, vocational assessment, and work tolerance screening (fitness for duty).

Acupuncture for the treatment of CRPS is thought to work by promoting relaxation and allowing chemicals and blood within the body to flow properly. Acupuncture may not be well tolerated by CRPS patients, but some have reported relief of pain that is immediate, but temporary, lasting only 1 or 2 hours. Acupuncture is recommended for subacute or chronic pain patients who are trying to increase function and/or decrease medication usage and have an expressed interest in this modality. It is also recommended for subacute or acute pain for patients who cannot tolerate NSAIDs or other medications, and it should generally be used in conjunction with manipulative and physical therapy/rehabilitation. Refer to the Division's Chronic Pain Disorder Medical Treatment Guideline for indications, evidence, and time frames.

Biofeedback is a form of behavioral medicine that helps patients learn self-awareness and self-regulation skills for the purpose of gaining greater control of their physiology, such as muscle activity, brain waves, and measures of autonomic nervous system activity. Stress-related psycho-physiological reactions may arise as a reaction to organic pain and in some cases may cause pain. Electronic instrumentation is used to monitor the targeted physiology and then displayed or fed back to the patient visually, auditorily, or tactilely, with coaching by a biofeedback specialist.

Refer to the Division's Chronic Pain Disorder Medical Treatment Guideline for indications, evidence, and time frames.

Complementary Medicine, termed Complementary Alternative Medicine (CAM) in some systems, is a term used to describe a broad range of treatment modalities, a number of which are generally accepted and supported by some scientific literature and others which still remain outside the generally accepted practice of conventional Western Medicine. In many of these approaches, there is attention given to the relationship between physical, emotional, and spiritual well-being. While CAM may be performed by a myriad of both licensed and non-licensed health practitioners with training in one or more forms of therapy, credentialed practitioners should be used when available or applicable.

All CAM treatments require prior authorization and must include agreed upon number of visits for time to produce functional effects.

Refer to the Division's Chronic Pain Disorder Medical Treatment Guideline for indications, evidence, and time frames.

Disturbances of sleep are common in chronic pain. An essential element of chronic pain treatment is restoration of normal sleep cycles. Although primary insomnia may accompany pain as an independent co-morbid 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 an increase in light sleep occur. Sleep efficiency, the proportion of time in bed spent asleep, is also decreased. These changes are associated with patient reports of non-restorative sleep. Sleep apnea may also occur as a primary diagnosis or be caused or exacerbated by opioid and hypnotic use.

Refer to the Division's Chronic Pain Disorder Medical Treatment Guideline for more information on behavioral modifications to address sleep disturbances.

Informed decision making is the hallmark of a successful treatment plan. In most cases, the continuum of treatment from the least invasive to the most invasive (e.g., surgery) should be discussed. The intention is to find the treatment along this continuum which most completely addresses the condition. Patients should identify their personal values and functional goals of treatment at the first visit. It is recommended that specific individual goals are articulated at the beginning of treatment as this is likely to lead to increased patient satisfaction above that achieved from improvement in pain or other physical function. Progress toward the individual functional goals identified should be addressed at follow-up visits and throughout treatment by other members of the health care team as well as an authorized physician.

Documentation of the informed decision process should occur whenever diagnostic tests or referrals from an authorized treating physician are contemplated. The informed decision making process asks the patients to set their personal functional goals of treatment and describe their current health status and any concerns they have regarding adhering to the diagnostic or treatment plan proposed. The provider should clearly describe the following:

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

* Return to work or maintaining work status.

* Fewer restrictions at work or when performing activities of daily living (ADLs).

* Decrease in usage of medications related to the work injury.

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

Visual analog scales (VAS) provide important subjective data but cannot be used to measure function.

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.

For post-MMI care, refer to Section J.4, Maintenance Management, Injection Therapy, in this guideline.

The DSM-V renames opioid addiction as substance use disorder (SUD) and classifies opioid use disorder according to categories defined as mild (2 - 3 features of stated criteria), moderate (4 - 5 features of stated criteria), or severe (6 - 7 features of stated criteria).

Definitions:

* Opioid physical dependence: opioid withdrawal symptoms (withdrawals) which occur as a result of abrupt discontinuation of an opioid in an individual who became habituated to the medication or through administration of an antagonist. Opioid physical dependency is not in and of itself consistent with the diagnosis of addiction/substance use disorder.

* Tolerance: a physiologic state caused by the regular use of an opioid in which increasing doses are needed to maintain the same affect. In patients with "analgesic tolerance," increased doses of the opioid may be needed to maintain pain relief.

* Opioid misuse: the utilization of opioid medications outside of the prescribing instructions for which it was originally prescribed. Misuse may be as innocuous as taking slightly more or less medications than prescribed to crushing or snorting an opioid.

* Opioid abuse: the use of any substance for a non-therapeutic purpose or the use of a medication for purposes other than those for which the agent is prescribed. Abuse includes intentional use for altering a state of consciousness. Abuse frequently affects the individual's ability to fulfill normal societal roles, resulting in difficulty with employment, or legal, or interpersonal problems.

* Pseudo-addiction: addiction-like behaviors consistent with overutilization of medications outside of the prescribing provider's instructions and recommendations for the express purpose of improved pain management. This occurs when a patient believes there is insufficient pain relief. Once pain is adequately managed with a higher dose of medications than initially prescribed or with improved therapy, the behaviors consistent with addiction are discontinued.

* Addiction: a primary chronic neurobiological disease influenced by genetic, psychosocial, and/or environmental factors. It is characterized by impaired control over drug use, compulsive drug use, and continued drug use despite harm and because of craving.

Substance use disorder/addiction in the workers' compensation system can be encountered in three ways. First, the individual has an active substance use disorder at the time of injury. The party responsible for treatment of the substance use disorder may be outside of the workers' compensation system. However, if there is no other paying party and the treatment is necessary in order to recover from the current workers' compensation injury, treatment may be covered by the workers' compensation payor. The second possibility is that a patient with a substance use disorder, who is currently in recovery at the time of the workers' compensation injury, relapses as a result of the medications which are prescribed by the treating provider. This patient may become re-addicted and will manifest substance use disorder characteristics and symptoms consistent with the diagnosis. The third possibility is an individual with no history of substance use disorder who is injured as a result of an occupational accident. This particular individual becomes "addicted" to the medications as a result of the medications being prescribed. This is most likely to occur with the use of opioids but could possibly occur with use of other medications such as benzodiazepines or specific muscle relaxants such as carisoprodol.

If the treating provider is suspicious of a patient exhibiting opioid misuse, abuse, or addiction, the patient should preferably be evaluated by a specialist in the field of addiction medicine. It would be the responsibility of the specialist to identify medication misuse, abuse, addiction, or pseudo-addiction and to determine what additional treatment, if any, needs to be implemented.

During the initial injury evaluation, an authorized treating provider should obtain an addiction history as part of a complete history and physical. If it is determined at the time of the initial evaluation by the treating provider that there is the pre-existing condition of active SUD or history of opioid addiction/SUD, then it is prudent to consider an evaluation with an addiction medicine physician prior to issuing opioid treatments if possible. The addiction medication specialist will be able to counsel the patient accordingly, determine medication needs, and determine the appropriate follow-up to hopefully avoid aggravation or relapse of substance abuse disorders which will complicate the recovery process. Many patients exhibit opioid misuse, opioid abuse, and pseudo-addictive behaviors. These issues can be managed once the problem is identified and a discussion is carried out with the patient regarding these abnormal behaviors.

Once the diagnosis of SUD is confirmed, an addiction medicine specialist familiar with addiction treatment should assist in co-managing the patient's care and the problematic drug prescriptions. This co-management technique is critical for the injured worker with a SUD diagnosis during the initial injury phase, recovery, and stabilization phase until he/she has reached MMI. If it is determined during the active treatment and recovery phase that there is no longer a need for opioids, then the addiction medicine specialist will be in charge of the transition from use of opioids to safe taper/discontinuation of the opioids while monitoring for relapse of addiction.

Co-management is equally important for managing the chronic pain patient that has a concomitant opioid addiction/SUD with a legitimate need for analgesic medications. The addiction medicine specialist in all likelihood will monitor the patient more closely including judicious prescribing, PDMP reviews, urine drug testing, drug counts, and clarifying functional improvement as a result of the medications prescribed and frequent follow-ups which may initially seem excessive.

All abstinence addiction treatment begins with a discontinuation of the addicting substance; this is referred to as the detox phase of the treatment and can be performed in a number of ways. However, detoxification alone is not considered adequate addiction treatment. Detoxification is simply a method of discontinuing the medications in an effort to stabilize the patient prior to more extensive treatment.

Phase 1:

The methods of detoxification can include 1) abrupt discontinuation - not recommended due to high rate of relapse due to craving and withdrawal symptoms, 2) slow but progressive taper - 10% of total dosage per week as an outpatient treatment, 3) conversion to a different medication opioid (buprenorphine/naloxone) to enable a more stable and comfortable taper occasionally done as an outpatient but commonly done as part of a more comprehensive treatment program, and 4) rapid detox under anesthesia - not recommended due to relatively high incidence of complications and high expense. The methodology chosen for phase 1 detoxification is left up to the specialist and is simply the initial phase of stabilization prior to considering the need for a phase 2 of addiction treatment program.

Phase 2:

Once a patient is safely through the detoxification phase and the condition is stabilized regardless of the method chosen, then successful addiction treatment begins generally utilizing a number of techniques to prevent the return to active substance use and addiction. This phase of treatment generally involves teaching the patient to develop control over the compulsions, psychosocial factors, and associated mental health issues which are critical to maintain abstinence. This phase of treatment is generally managed in a 30 - 90 day non-hospital residential treatment program. The treatment prescribed in a residential treatment program generally includes individual and group therapy with certified addiction counselors and psychologists. Phase 2 of treatment may or may not be combined with opioid substitution therapy with medications such as buprenorphine/naloxone (partial agonist of the opioid receptor), methadone, or naltrexone. Injectable depot naltrexone may be used.

Buprenorphine/naloxone therapy utilizes a sublingual partial opioid receptor agonist which binds to the opioid receptor, reducing craving and resulting in analgesia when necessary. Due to its high affinity to the opioid receptor, it blocks the effect of non-approved additional opioid use. The buprenorphine is administered either sublingually or, when FDA approved, as a subcutaneous implant. Naloxone was added to the sublingual drug formulation to discourage using this medication intravenously. With intravenous administration of buprenorphine/naloxone, the naloxone becomes absorbed neutralizing the effects of opioids. Buprenorphine/naloxone can be an excellent option in patients requiring analgesic medications with a prior history of opioid addiction because buprenorphine results in less sedation and euphoria then the other standard schedule II opioid medications. Prescribing Suboxone film (buprenorphine/naloxone) for addiction purposes can only be done by a physician and requires special training and certification. Once special training is completed, an application is filed with the DEA to obtain a special DEA license referred to as an X-DEA number. This X-DEA number needs to accompany all prescription for Suboxone when delivered to the pharmacy and identifies the prescription is being issued specifically for the treatment of addiction/SUD.

Methadone may be an option if the patient is admitted to a federally licensed methadone treatment facility where a daily dose of medication is administered and the patient continues to utilize therapeutic treatments/cognitive behavioral therapies as noted above. 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. The methodology and rationale for methadone treatment is to saturate the opioid receptors with methadone (a slow onset and prolonged duration opioid), reducing the opioid craving. The majority of the opioid receptors are bound by the methadone leaving very few unbound opioid receptors available in the event additional opioids are utilized in an attempt to achieve the euphoric effect. When the patient is stabilized on a methadone dose determined by the federally licensed methadone clinic and their associated physicians, the patient's drug-seeking, craving, legal issues, and attempts to utilize non-approved medications is reduced. Patients will frequently return to more productive lives free of the compulsions, cravings, and legal issues and are usually able to maintain jobs and improve family dynamics.

Other medications which may be useful and can be utilized during the phase 2 and 3 treatment include opioid receptor antagonists such as naltrexone (ReVia, Vivitrol) which produces no euphoria. The purpose of naltrexone therapy is to add an additional layer of protection and treatment for the patients by allowing them to receive a daily oral dose of naltrexone (ReVia) or a monthly injection of naltrexone (Vivitrol). Administration of naltrexone will bind with very high affinity to the opioid receptor resulting in the opioid receptors being non-responsive to other opioid utilization thereby preventing any euphoric response or reinforcement with unsanctioned opioid use. This treatment method can be problematic in an individual receiving intramuscular naltrexone therapy especially if that individual requires surgery and post-operative pain management because the analgesics needed for post-operative pain management will be significantly less effective because of the prolonged opioid antagonist properties of the naltrexone.

In Summary:

Medication assisted treatment for patients addicted to opioids is the treatment recommended by most experts. A Canadian evidence-based guideline recommends long-term treatment with buprenorphine/naloxone, or methadone for some patients, based on the high relapse rate without medication assistance. The likelihood of relapse in the workers' compensation population for individuals who have become addicted through prescription drug use is unknown. Buprenorphine implants are likely equally effective as sublingual buprenorphine for preventing illicit opioid use. Implants are significantly more costly. Naltrexone treatment, an opioid agonist, has also been used to maintain abstinence. It can be provided in monthly injections or orally 3 times per week. Choice of these medications should be made by the addiction specialist.

Phase 3:

Aftercare begins after discharge from the non-hospital residential treatment program and is designed for long-term management of addiction. This phase is potentially the time when relapse is most likely to occur if the patient has not developed significant skills necessary to deal with the compulsions, cravings, and associated psychosocial factors contributing to SUD. Long-term strategies include 1) intense outpatient programs (IOP), 2) group therapy/meetings such as Narcotics Anonymous, and 3) residential communities (RC) which are groups of patients living together in a community for up to 6 months for the express purpose of maintaining abstinence from their drug of choice but at the same time transitioning and learning how to live in the general community. Residential communities are extremely useful to give patients an opportunity to be reintroduced to employment and psychosocial interactions with family and friends while maintaining contact with the community supporting their addiction recovery. In addition, phase 3 medication treatment may include utilization of opioid substitution therapy (buprenorphine/naloxone) or opioid receptor antagonist therapy as noted above.

It must be noted that relapse is common despite the utilization of intense cognitive behavioral therapy, addiction treatment strategies, and long-term phase 3 treatment and medication. Risk monitoring should be continued, including checking for behavioral aberrancies, checking the PDMP, and drug testing,. Additional treatment or readmission for repeat treatment is not uncommon.

Chemical dependency for workers' compensation issues will usually be related to opioids, anxiolytics, or hypnotics as prescribed for the original workers' compensation injury. Chemical dependency should be treated with specific programs providing medical and psychological assessment, treatment planning, and individual as well as group counseling and education. Established functional goals which are measurable, achievable, and time specific are required.

Inpatient or outpatient programs may be used, depending upon the level of intensity of services required. Formal inpatient treatment programs are appropriate for patients who have more intense (e.g., use extraordinarily excessive doses of prescription drugs to which they have developed tolerance) or multiple drug abuse issues (e.g., benzodiazepines and/or alcohol) and those with complex medical conditions or psychiatric issues related to drug misuse. A medical physician with appropriate training and preferably board certified in addiction medicine should provide the initial evaluation and oversee the program. Full primary assessment should include behavioral health assessment; medical history; physical examination; mental status; current level of functioning; employment history; legal history; history of abuse, violence, and risk taking behavior; education level; use of alcohol, tobacco and other drugs; and social support system. The initial medical exam should include appropriate laboratory testing such as liver function, screening for sexual diseases, etc.

Addiction specialists, alcohol and drug counselors, psychologists, psychiatrists, and other trained health care providers as needed, are involved in the program. Peer and group support is an integral part of the program and families are encouraged to attend. Peer support specialists should receive competency based training. A designated individual is assigned to each worker to assist in coordinating care. There should be good communication between the program and other external services, external health care providers, Al-Anon, Alcoholics Anonymous (AA), and pain medicine providers. Drug screening should be performed as appropriate for the individual, at least weekly during the initial detoxification and intensive treatment phases. At least 8 random drug screens per year should be completed for those on medication assisted treatment and drug diversion control methods should be in place.

Clear withdrawal procedures are delineated for voluntary, against medical advice, and involuntary withdrawal. Withdrawal programs must have a clear treatment plan and include description of symptoms of medical and emotional distress, significant signs of opioid withdrawal, and actions taken. All programs should have clear direction on how to deal with violence in order to assure safety for all participants. Transition and discharge should be carefully planned with full communication to outside resources. Duration of inpatient programs are usually 4 weeks while outpatient programs may take 12 weeks.

Drug detoxification may be performed on an outpatient or inpatient basis. Detoxification is unlikely to succeed in isolation when not followed by prolonged chemical dependency treatment. Isolated detoxification is usually doomed to failure with very high recidivism rates.

Both ultra-rapid and rapid-detoxification are not recommended due to possible respiratory depression and death and the lack of evidence for long range treatment success. Refer to Section H.9, Opioid Addiction Treatment, for more specific details on treatment plans.

Tapering opioids on an outpatient basis requires a highly motivated patient and diligent treatment team and may be accomplished by decreasing the current dose 10% per day or per week. Tapering programs under the supervision of physicians with pain expertise may proceed more aggressively. Tapering should be accompanied by addiction counseling. Failing a trial of tapering, a patient should be sent to a formal addiction program. When the dose has reached 1/3 of the original dose, the taper should proceed at half or less of the initial rate. Doses should be held or possibly increased if severe withdrawal symptoms, pain, or reduced treatment failure otherwise occurs. This method is tedious, time consuming, and more likely to fail than more rapid and formalized treatment programs.

Psychosocial treatment is a well-established therapeutic and diagnostic intervention with selected use in acute pain problems and 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.

Refer the Division's Chronic Pain Disorder Medical Treatment Guideline for indications, evidence, and time frames.

Some level of immobility may occasionally be appropriate which could include splinting/casting or as part of a structured schedule that includes energy conservation or intentional rest breaks between activities. While these interventions may occasionally have been ordered in the acute phase, the provider should be aware of their impact on the patient's ability to adequately comply with and successfully complete rehabilitation. Activity should be increased based on the improvement of core strengthening.

Patients should be educated regarding the detrimental effects of immobility versus the efficacious use of limited 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.

A prolonged time off work is likely to lead to chronic disability. In complex cases, experienced nurse case managers may be required to assist in return to work. Other services, including psychological evaluation and/or treatment, jobsite analysis, and vocational assistance, may be employed.

Refer the Division's Chronic Pain Disorder Medical Treatment Guideline for considerations and recommendations.

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 functional status in regard to the specific diagnosis, 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. Therapy in this section should not be merely a repeat of previous therapy but should focus specifically on the individual goals and abilities of the patient with CRPS.

The goal of active therapy is to teach the patient exercises that they can perform regularly on their own. Patients should be instructed to continue active therapies at home as an extension of the treatment process in order to maintain improvement levels. Follow-up visits to reinforce and monitor progress and proper technique are recommended. Home exercise can include exercise with or without mechanical assistance or resistance and functional activities with assistive devices.

On occasion, specific diagnoses and post-surgical conditions may warrant durations of treatment beyond those listed as "maximum." Factors such as exacerbation of symptoms, re-injury, interrupted continuity of care, need for post-operative therapy, and co-morbidities may also extend durations of care. Specific goals with objectively measured functional improvement during treatment must be cited to justify extended durations of care. It is recommended that, if no functional gain is observed after the number of treatments under "time to produce effect" has been completed, then alternative treatment interventions, further diagnostic studies, or further consultations should be pursued.

Pain Neuroscience Education (PNE): PNE is an educational strategy used by physical therapists and other practitioners that focuses on teaching people in pain more about the neurobiological and neurophysiological processes involved in their pain experience, versus a focus on anatomical and pathoanatomical education. PNE helps patients develop an understanding of various pain processes including central sensitization, peripheral sensitization, inhibition, facilitation, the brain's processing of threat appraisal, and various biological systems involved in a pain experience. This reconceptualization of pain via PNE is then combined with various behavioral strategies including aerobic exercise, pacing, graded exposure, graded activity, and goal setting. PNE is likely to positively influence pain ratings, disability, fear-avoidance behaviors, pain catastrophization, limitations in movement, pain knowledge, and healthcare utilization. PNE is recommended with active therapy for chronic pain patients.

Since CRPS and SMP patients frequently have additional myofascial pain generators, other active therapies not listed may be used in treatment. Refer to the Division's Chronic Pain Disorder Medical Treatment Guideline for therapies and timeframe parameters not listed.

The following active therapies are listed in alphabetical order:

On occasion, specific diagnoses and post-surgical conditions may warrant durations of treatment beyond those listed as "maximum". 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.

The following passive therapies are listed in alphabetical order:

Spinal cord stimulation (SCS) is the delivery of low-voltage electrical stimulation to the spinal cord or peripheral nerves to inhibit or block the sensation of pain. The system uses implanted electrical leads and a battery powered implanted pulse generator (IPG).

Refer the Division's Chronic Pain Disorder Medical Treatment Guideline for indications and evidence.

Description: neurostimulator device implanted in the epidural space near to dorsal root ganglion - up to 4 leads may be placed. It is used for lower extremity CRPS pain.

There is good evidence that dorsal root ganglion (DRG) stimulation is non-inferior to conventional SCS with respect to pain relief for CRPS patients with lower extremity pain. There is some evidence that DRG stimulation is superior to SCS with respect to pain relief for up to 12 months after implantation. Neurological deficits related to stimulation with either device appear to be rare. 46% of the DRG patients had more serious complications compared to 26% for SCS.

Particular technical expertise is required to perform this procedure and is available in some neurosurgical, rehabilitation, and anesthesiology training programs and fellowships. Physicians performing this procedure must be trained in neurostimulation implantation and participate in ongoing training workshops on this subject, such as those sponsored by the Spine Intervention Society (SIS), North American Neuromodulation Society (NANS), or as sponsored by implant manufacturers.

Complications: Serious, extremely rare complications include spinal cord compression, paraplegia, epidural hematoma, and epidural hemorrhage. Other less serious complications / undesirable side effects include undesirable change in stimulation, seroma, CSF leakage, infection, erosion, allergic response, accidental dural puncture, hardware malfunction or equipment migration, pain at implantation site, loss of pain relief, chest wall stimulation, and other surgical risks. Neurological deficits related to stimulation with either device appear to be rare. 46% of the DRG patients had complications (mostly technical issues) compared to 26% for SCS.

Surgical Indications: Patients with established CRPS I or II with persistent, functionally limiting lower extremity pain. Candidates must have failed full conservative therapy including active therapy, medical management with at least 2 medications, and therapeutic injections. They must also have completed psychological treatment and evaluation and have a successful stimulator trial. Prior authorization is required. Habituation to opioid analgesics in the absence of a history of addictive behavior does not preclude the use of SCS. Patients with severe psychiatric disorders and issues of secondary gain or one or more primary risk factors are not candidates for the procedure, and the prognosis worsens as the number of secondary risk factors increases. Approximately, one third to one half of patients who qualify for SCS can expect a substantial reduction in pain relief; however, it may not influence allodynia and hypesthesia. Patients' expectations need to be realistic, and therefore, patients should understand that the intervention is not a cure for their pain but rather a masking of their symptomatology which might regress over time. Historically, there appears to be a likely benefit of up to 3 years with spinal cord stimulator. It may be similar with the DRG.

Prior to surgical intervention, the patient and treating physician should identify functional operative goals and the likelihood of achieving improved ability to perform activities of daily living or work, as well as possible complications. The patient should agree to comply with the pre- and post-operative treatment plan including home exercise. The provider should be especially careful to make sure the patient understands the amount of post-operative therapy required and the length of partial- and full-disability expected post-operatively.

Informed decision making should be documented for all invasive procedures. This must include a thorough discussion of the pros and cons of the procedure and the possible complications as well as the natural history of the identified diagnosis. Since many patients with the most common conditions will improve significantly over time, without invasive interventions, patients must be able to make well-informed decisions regarding their treatment.

Smoking may affect soft tissue healing through tissue hypoxia. Patients should be strongly encouraged to stop smoking and be provided with appropriate counseling by the physician. If a treating physician recommends a specific smoking cessation program peri-operatively, this should be covered by the insurer. Typically, the patient should show some progress toward cessation at about 6 weeks. Physicians may monitor smoking cessation with laboratory tests such as cotinine levels. The surgeon will make the final determination as to whether smoking cessation is required prior to surgery. Patients with demonstrated success may continue the program up to 3 months or longer if needed based on the operative procedure. Refer to Section G.10.j, Smoking Cessation Medications and Treatment, in the Division's Chronic Pain Disorder Medical Treatment Guideline for further details.

DRG may be indicated in a subset of patients who have confirmed CRPS, have burning pain in a distribution amenable to stimulation coverage, and have pain at night not relieved by position. The extremity pain should account for at least 50% or greater of the overall leg and back pain experienced by the patient.

Prior to the stimulator trial, a comprehensive psychiatric or psychological evaluation, for a chronic pain evaluation. Refer to the Division's Chronic Pain Disorder Medical Treatment Guideline for more information. This evaluation should include a standardized detailed personality inventory with validity scales (e.g., MMPI-2, MMPI-2-RF, or PAI); pain inventory with validity measures (e.g., BHI 2, MBMD); clinical interview and complete review of the medical records. The psychologist or psychiatrist performing these evaluations should not be an employee of the physician performing the implantation. This evaluation must be completed, with favorable findings, before the screening trial is scheduled. Before proceeding to a spinal stimulator trial, the evaluation should find the following:

* No indication of falsifying information;

* No indication of invalid results on testing;

* No primary psychiatric risk factors or "red flags" (e.g., psychosis, active suicidality, severe depression, or addiction). (Note that tolerance and dependence to opioid analgesics are not addictive behaviors and do not preclude implantation);

* A level of secondary risk actors or "yellow flags" (e.g., moderate depression, job dissatisfaction, dysfunctional pain conditions) judged to be below the threshold for compromising the patient's ability to benefit from neurostimulation.

* The patient is cognitively capable of understanding and operating the neurostimulation control device;

* The patient is cognitively capable of understanding and appreciating the risks and benefits of the procedure;

* The patient is familiar with the implications of having an implant, can accept the complications, potential disfigurement, and effort it takes to maintain the device;

* The patient is cognitively capable of understanding the course of injury both with and without neurostimulation;

* The patient has demonstrated a history of motivation in and adherence to prescribed treatments;

* The patient understands the work related restrictions that may occur with placement of the stimulator. All reasonable surgical and non-surgical treatment has been exhausted;

* The topography of pain and its underlying pathophysiology are amenable to stimulation coverage (the entire painful area has been covered); and

* A successful neurostimulation screening test of at least 5 to 7 days.

For a neurostimulation screening test, a temporary lead is implanted at the level of pain and attached to an external source to validate therapy effectiveness. A screening test is considered successful if the patient meets both of the following criteria:

There are no randomized controlled studies for this treatment. This modality should only be employed with a clear nerve injury or when the majority of pain is clearly in a nerve distribution in patients who have completed 6 months of other appropriate therapy including the same pre-trial psychosocial evaluation and treatment as are recommended for spinal cord stimulation. A screening trial should take place over 3 to 7 days and is considered successful if the patient meets both of the following criteria:

Not generally recommended. Requires prior authorization. Due to conflicting studies in this population and complication rate for long-term use, it may be considered only in very rare occasions when dystonia and spasticity are dominant features or when pain is not able to be managed using any other non-operative treatment.

Refer the Division's Chronic Pain Disorder Medical Treatment Guideline for indications.

Description: destruction of part of the sympathetic nervous system, which is not generally accepted or widely used. Long-term success with this pain relief treatment is poor. Expected duration of pain relief is 3 to 5 months. There is currently a lack of evidence supporting long-term pain relief, and increased pain can result. This procedure is generally not recommended and requires prior authorization. It may be considered for patients who are unable to return to normal activities of daily living when using the other non-operative treatments (as listed in Section G, Non-operative Procedures) and who meet the strict indications below.

The practice of surgical and chemical sympathectomy for neuropathic pain and CRPS is based on very little high quality evidence. Sympathectomy should be used cautiously in clinical practice, in carefully selected patients, and probably only after failure of other treatment options. In these circumstances, establishing a clinical register of sympathectomy may help to inform treatment options on an individual patient basis.

Indications: single extremity CRPS I with a significant amount of sympathetically mediated ischemia and distal pain only. The procedure should not be done if the proximal extremity is involved. Local anesthetic stellate ganglion block or lumbar sympathetic block consistently gives 90 to 100% relief each time a technically good block is performed and results in a temperature difference between the affected and the unaffected extremity of at least 1°C. The procedure may be considered for individuals who have limited duration of relief from blocks. Permanent neurological complications are common.

Amputation is not recommended in CRPS except in cases of gangrene or frequent/recurrent limb infections with the risk for osteomyelitis or systemic sepsis.

* The medications should be clearly linked to improvement of function, not just pain control. All follow-up visits should document the patient's ability to perform routine functions satisfactorily. Examples include the abilities to perform: work tasks, drive safely, pay bills or perform basic math operations, remain alert and upright for 10 hours per day, or participate in normal family and social activities. If the patient is not maintaining reasonable levels of activity the patient should usually be tapered from the opioid and tried on a different long-acting opioid.

* A lower risk opioid medication regimen is defined as less than 50 MME per day. This may minimally increase or decrease over time. Dosages will need to be adjusted based on side effects of the medication and objective function of the patient. A patient may frequently be maintained on non-opioid medications to control side effects, treat mood disorders, or control neuropathic pain; however, only one long-acting opioid and one short-acting opioid for rescue use should be prescribed. Buccally absorbed opioids other than buprenorphine are not appropriate for these non-malignant pain patients. Transdermal opioid medications are not recommended, other than buprenorphine.

* All patients on chronic opioid medication dosages need to sign an appropriate opioid contract with their physician for prescribing the opioids.

* The patient must understand that continuation of the medication is contingent on their cooperation with the maintenance program. Use of non-prescribed drugs may result in tapering of the medication. The clinician should order random drug testing at least annually and when deemed appropriate to monitor medication compliance.

* Patients on chronic opioid medication dosages must receive them through one prescribing physician.