Contents part 1: Introduction




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While not recommended as an isolated intervention, the following patient selection criteria should be documented by the medical care provider for Interferential Current Stimulation to be determined medically necessary:

Possibly appropriate for the following conditions if it has been documented and proven to be effective as directed or applied by the physician or a provider licensed to provide physical therapy:

- Pain is ineffectively controlled due to diminished effectiveness of medications; or

- Pain is ineffectively controlled with medications due to side effects; or

- History of substance abuse; or

- Significant pain from postoperative or acute conditions limits the ability to perform exercise programs/physical therapy treatment; or

- Unresponsive to conservative measures (e.g., repositioning, heat/ice, medications, etc.).

If those criteria are met, then a one-month trial may be appropriate to permit the physician and physical therapy provider to study the effects and benefits. There should be evidence of increased functional improvement, less reported pain and evidence of medication reduction.



A “jacket” should not be certified until after the one-month trial and only with documentation that the individual cannot apply the stimulation pads alone or with the help of another available person. If treatment is determined to be medically necessary, as with all other treatment modalities, the efficacy and continued need for this intervention should be periodically reassessed and documented. Treatment of unlimited duration is not recommended.

Internal qigong

Not recommended. This review of controlled clinical trials focused on the effects of internal qigong, a self-directed energy healing intervention involving movement and meditation. Collectively, the existing trial evidence is not convincing enough to suggest that internal qigong is an effective modality for pain management. (Lee, 2009) Qi Gong or Qigong is a traditional Chinese medicine technique. There are two types of qigong: internal and external. Internal qigong techniques include learned and self-directed exercises that involve sounds, movements and meditation. External qigong (Qi emission) is practiced by a Qi Gongmaster who uses his or her hands with the aim to project qi ("chi") to others for the purpose of healing. In traditional Chinese medicine, qigong is considered beneficial for a large variety of medical conditions. Many practitioners believe there is a role for qigong in treating chronic conditions such as cancer, chronic fatigue syndrome, osteoporosis, high blood pressure, stomach ulcers and asthma. There is early research supporting the use of internal qigong exercises or externally applied Qi for pain management and reduction of anxiety associated with pain. More evidence is needed before a firm recommendation can be made. Qigong is generally believed to be safe when practiced appropriately, but it should not be used as the sole treatment for severe illnesses, and people with psychiatric disorders should only practice qigong under supervision.

Intrathecal drug delivery systems (IDDSs)

See Implantable drug-delivery systems (IDDSs).

Intrathecal pumps

See Implantable drug-delivery systems (IDDSs).

Intravenous regional sympathetic blocks (for RSD/CRPS)

Not recommended due to lack of evidence for use. There is no role for IV diagnostic blocks with phentolamine or IVRA with guanethidine. Other procedures include IV regional blocks with lidocaine, lidocaine-methyl-prednisolone, droperidol, ketanserin, atropine, bretylium, clonidine, and reserpine. If used, there must be evidence that the Budapest criteria have been met and all other diagnoses have been ruled out. Evidence of sympathetically mediated pain should be provided. The reason for the necessity of this procedure over-and-above a standard sympathetic block should also be provided. (Perez, 2010) (Harden, 2013) (Tran, 2010) See also CRPS, sympathetic blocks (therapeutic).

Kadian® (morphine sulfate)



See DWC “Guideline for the Use of Opioids to Treat Work-Related Injuries” for recommendations on the use of opioids. According to the FDA approved prescribing information, “Use of Kadian as the First Opioid Analgesic:” There has been no evaluation of Kadian as an initial opioid analgesic in the management of pain. (FDA, 2010) Kadian is not for use as an as-needed (PRN) analgesic. It is not for use for pain that is mild or not expected to persist for an extended period of time. It is not for use for acute pain and not for use for postoperative pain unless the patient is already receiving chronic opioid therapy. Dosing: There is no data to support the use of Kadian more than every 12 hours. Comparison to use of other extended-release morphine formulations: Research has shown no significant difference between Kadian (in 24 and 12 hour dosing duration) as compared to MS Contin treatment of cancer pain in terms of or safety. (Broomhead, 1997) (Gourlay 1997) Bioequivalence: As per the Package Insert, Kadian is not bioequivalent to other extended-release morphine preparations. The slower release of morphine may result in reduced maximum and increased minimum plasma morphine concentrations than with shorter acting morphine products. Conversion to other extended-release morphine preparations may lead to either excessive sedation at peak or inadequate analgesia at trough. The FDA Orange Book (accessed March 2013) has determined that actual or potential bioequivalence problems have been resolved with adequate in vivo and/or in vitro evidence supporting bioequivalence.

Ketamine

Not recommended. There is insufficient evidence to support the use of ketamine for the treatment of CRPS. Current studies are experimental and there is no consistent recommendation for protocols, including for infusion solutions (in terms of mg/kg/hr), duration of infusion time, when to repeat infusions, how many infusions to recommend, or what kind of outcome would indicate the protocol should be discontinued. The safety of long-term use of the drug has also not been established, with evidence of potential of neurotoxicity. Ketamine-induced liver toxicity is a major risk, occurring up to 50% of the time, and regular measures of liver function are therefore required during such treatments. (Noppers, 2011) Frequent use can cause long-term memory impairment and altered pre-frontal dopaminergic function. (Morgan, 2012) Ketamine is also known as a drug of abuse. Abuse of ketamine can cause cystitis and a contracted bladder, and secondary renal damage can occur in severe cases which might be irreversible, rendering patients dependent on dialysis. (Chu, 2008) (Morgan, 2012) There is no evidence of a cure of CRPS with subanesthetic infusions. The limited results of current research studies on this topic are inconsistent. An early successful retrospective report of 33 patients documented that 54% of patients experienced greater than 3 months of pain relief, with 31% experiencing greater than 6 months of relief. The authors reported the long-term effects of ketamine infusion were unknown and could include neurotoxicity and hepatic dysfunction. (Correll, 2004) Subsequent non-controlled studies have found less impressive findings (using probability statistics due to lack of long-term follow-up of 41% of patients), predicting a 13% to 31% chance of relief lasting more than three weeks. (Patil, 2011) Another study has shown decreased pain scores but no functional improvement. (Sigtermans, 2009) The overall current recommendation is that larger randomized placebo controlled trials occur, looking at dosing and long-term follow-up. (Schwartzman, 2009) Subcutaneous ketamine used as an adjunct to opioids for neuropathic and nociceptive pain provides no benefit and increases adverse events significantly, according to this double-blind RCT. (Hardy, 2012)

Ketoprofen

Recommended as an option. See NSAIDs (non-steroidal anti-inflammatory drugs); NSAIDs, GI symptoms & cardiovascular risk; NSAIDs, hypertension and renal function; & NSAIDs, specific drug list & adverse effects for general guidelines, as well as specific Ketoprofen listing for more information and references.

Ketoprofen, topical

Under study as a first-line treatment in the U.S. See Topical analgesics, Non-steroidal antinflammatory agents (NSAIDs), and the ketoprofen topical listing, for more information and references. Topical NSAIDs are generally recommended for short-term use for acute sprain/strains and longer term for osteoarthritis of the knee and hand, particularly in individuals with risk for GI ulceration, but they are not indicated for treatment of the low back or neuropathic pain. At this time, the only available FDA-approved topical NSAID is diclofenac, but recent high-quality studies have identified a dangerous increased risk profile with diclofenac, including topical formulations, making it a second-line recommended treatment in ODG. Topical ketoprofen has been approved by the European FDA (the European Medicines Agency), and the European EULAR and NICE guidelines state these approved formulations of topical ketoprofen should be a first-line treatment, and should be considered before oral NSAIDs because they have shown efficacy significantly superior to placebo and similar to oral NSAIDs, without the same risks of adverse effects. While there are no FDA approved formulations of topical ketoprofen available in the U.S., the product is available from compounding pharmacies. Compound medications are not FDA approved, but they are allowed under state pharmacy regulations. See Compound drugs. Because each compounding pharmacy may create their own version, FDA cannot be a source of information on safety and effectiveness of each version, or on generic equivalency. At this time, there are no high-quality studies of any of the various pharmacy compounded formulations of topical ketoprofen available in the U.S. Also, while topical ketoprofen has been used extensively in Europe, in 2009 France removed this product from the market due to photosensitivity reactions. The drug has been reinstated, but this may be a serious problem. See the ketoprofen topical listing in Topical analgesics, Non-steroidal antinflammatory agents.

Ketorolac (Toradol®)

See NSAIDs (non-steroidal anti-inflammatory drugs); NSAIDs, GI symptoms & cardiovascular risk; NSAIDs, hypertension and renal function; & NSAIDs, specific drug list & adverse effects for general guidelines, as well as specific Ketorolac (Toradol®) listing for more information and references, where it is indicated that the oral formulation should not be given as an initial dose, but only as continuation following IV or IM dosing. Ketorolac, when administered intramuscularly, may be used as an alternative to opioid therapy. (DeAndrade, 1994)

Lacosamide (Vimpat®)

Not recommended as as a first-line therapy for use in neuropathic pain. Lacosamide (Vimpat) is a novel antiepileptic medication that is approved only for adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy. Despite a number of clinical studies conducted to evaluate lacosamide efficacy and safety in treating diabetic peripheral neuropathy, the FDA has declined to approve this indication. There are a number of safety concerns related to lacosamide, including second and third degree AV block, atrial fibrillation and flutter, and neurotoxicity. (O'Lenic, 2012)

Lamotrigine (Lamictal®)

See Anti-epilepsy drugs (AEDs) for general guidelines, as well as specific Lamotrigine listing.

Lazanda (fentanyl nasal spray)

Not recommended for musculoskeletal pain. See Fentanyl.

Levetiracetam (Keppra®)

See Anti-epilepsy drugs (AEDs) for general guidelines, as well as specific Levetiracetam listing.







Lidocaine (anesthetic)

Lidocaine is a local anesthetic. See CRPS, medications; CRPS, sympathetic and epidural blocks; Topical analgesics.

Lidoderm® (lidocaine patch)

Not recommended until after a trial of a first-line therapy, according to the criteria below. Lidoderm® is the brand name for a lidocaine patch produced by Endo Pharmaceuticals. Topical lidocaine may be recommended for localized neuropathic pain after there has been evidence of a trial of first-line therapy (tri-cyclic or SNRI anti-depressants or an AED such as gabapentin or Lyrica). This is not a first-line treatment and is only FDA approved for post-herpetic neuralgia. Formulations that do not involve a dermal-patch system are generally indicated as local anesthetics and anti-pruritics. For more information and references, see Topical analgesics.

Criteria for use of Lidoderm patches:

(a) Recommended for a trial if there is evidence of localized pain that is consistent with a neuropathic etiology.

(b) There should be evidence of a trial of first-line neuropathy medications (tri-cyclic or SNRI anti-depressants or an AED such as gabapentin or Lyrica).

(c) This medication is not generally recommended for treatment of osteoarthritis or treatment of myofascial pain/trigger points.

(d) An attempt to determine a neuropathic component of pain should be made if the plan is to apply this medication to areas of pain that are generally secondary to non-neuropathic mechanisms (such as the knee). One recognized method of testing is the use of the Neuropathic Pain Scale.

(e) The area for treatment should be designated as well as number of planned patches and duration for use (number of hours per day).

(f) A Trial of patch treatment is recommended for a short-term period (no more than four weeks).

(g) It is generally recommended that no other medication changes be made during the trial period.

(h) Outcomes should be reported at the end of the trial including improvements in pain and function, and decrease in the use of other medications. If improvements cannot be determined, the medication should be discontinued.

(i) Continued outcomes should be intermittently measured and if improvement does not continue, lidocaine patches should be discontinued.



Limbrel (flavocoxid)

Not recommended for treatment of chronic pain. See Medical foods.

Lorazepam

Not recommended. See Benzodiazepines.

Low level laser therapy (LLLT)

Not recommended. There has been interest in using low-level lasers as a conservative alternative to treat pain. Low-level lasers, also known as "cold lasers" and non-thermal lasers, refer to the use of red-beam or near-infrared lasers with a wavelength between 600 and 1000 nm and Watts from 5-500 milliwatts. (In contrast, lasers used in surgery typically use 300 Watts.) When applied to the skin, these lasers produce no sensation and do not burn the skin. Because of the low absorption by human skin, it is hypothesized that the laser light can penetrate deeply into the tissues where it has a photobiostimulative effect. One low-level laser device, the MicroLight 830 Laser, has received clearance for marketing from the U.S. Food and Drug Administration (FDA) specifically for the treatment of carpal tunnel syndrome. Other protocols have used low-level laser energy applied to acupuncture points on the fingers and hand. This technique may be referred to as "laser acupuncture." Given the equivocal or negative outcomes from a significant number of randomized clinical trials, it must be concluded that the body of evidence does not allow conclusions other than that the treatment of most pain syndromes with low level laser therapy provides at best the equivalent of a placebo effect. (Naeser, 2002) (Gur, 2002) (Basford, 1999) (Conti, 1997) (de Bie, 1998) (BlueCross BlueShield, 2005) Low Level Laser Therapy (LLLT) was introduced as an alternative non-invasive treatment for Osteoarthritis (OA) about 20 years ago, but its effectiveness is still controversial. For OA, the results are conflicting in different studies and may depend on the method of application and other features of the LLLT application. Despite some positive findings, data is lacking on how LLLT effectiveness is affected by four important factors: wavelength, treatment duration of LLLT, dosage and site of application over nerves instead of joints. There is clearly a need to investigate the effects of these factors on LLLT effectiveness for OA in randomized controlled clinical trials. (Brosseau-Cochrane, 2004) This meta-analysis concluded that there are insufficient data to draw firm conclusions about the effects of LLLT for low-back pain compared to other treatments, different lengths of treatment, different wavelengths and different dosages. (Yousefi-Nooraie-Cochrane, 2007)

Lubiprostone (Amitiza®)

Recommended only as a possible second-line treatment for opioid-induced constipation. See Opioid-induced constipation treatment.

Lumbar sympathetic block

Recommended as indicated below. Useful for diagnosis and treatment of pain of the pelvis and lower extremity secondary to CRPS-I and II. This block is commonly used for differential diagnosis and is the preferred treatment of sympathetic pain involving the lower extremity. For diagnostic testing, use three blocks over a 3-14 day period. For a positive response, pain relief should be 50% or greater for the duration of the local anesthetic and pain relief should be associated with functional improvement. Should be followed by intensive physical therapy. (Colorado, 2002)

Lunesta (Eszopicolone)

See Eszopicolone (Lunesta).

Lymph drainage therapy

Not recommended. Manual lymphatic drainage therapy, as performed by massage therapists, is intended to stimulate or move excess fluid away from the swollen area so that it can drain away normally. As a treatment for chronic pain, there is no good evidence to support its use. The results of this RCT indicate that, during the first 6 months of complex regional pain syndrome type I, manual lymph drainage provides no additional benefit when applied in conjunction with an intensive exercise program. (Uher, 2000)

Lyrica® (pregabalin)

Lyrica® is the brandname for pregabalin, and it is produced by Pfizer. See Pregabalin (Lyrica®).

Magnet therapy

Not recommended. Biomagnetic therapy is considered investigational. The data from randomized, placebo-controlled clinical trials fails to demonstrate that biomagnetic therapy results in improved health outcomes for any type of pain. Biomagnetic therapy has been proposed for the relief of chronic painful conditions; it is proposed that magnets, worn close to the skin, create an electromagnetic field within the body that suppresses pain. The theory is that the magnetic field causes potassium channels to be stimulated, producing repolarization or hyperpolarization. Biomagnetic therapy has been investigated for various types of pain, including peripheral neuropathy, chronic low back pain, carpal tunnel syndrome, plantar heel pain and hip and knee pain due to osteoarthritis. (Collacott-JAMA, 2000) (Maher, 2004) (BlueCross BlueShield, 2005)

Manual therapy & manipulation

Manual therapy and manipulation, also known as chiropractic treatment, are passive interventions that are considered adjuncts to other recommended treatment, especially active interventions (e.g., exercise). Recommended for chronic pain if caused by musculoskeletal conditions, and only when manipulation is specifically recommended by the provider in the plan of care. Manual Therapy is widely used in the treatment of musculoskeletal pain with the intended goal of positive symptomatic or objective measurable gains in functional improvement that facilitate progression in the patient's therapeutic exercise program and return to productive activities. Manipulation is manual therapy that moves a joint beyond the physiologic range-of-motion but not beyond the anatomic range-of-motion. Manipulation under anesthesia is not recommended. See also

specific body-part chapters in the DWC MTUS.



Recommended treatment parameters:

a. Time to produce effect: 4 to 6 treatments.

b. Frequency: 1 to 2 times per week for the first 2 weeks as indicated by the severity of the condition. Treatment may continue at 1 treatment per week for the next 6 weeks.

c. Maximum duration: 8 weeks. At week 8, patients should be reevaluated. Care beyond 8 weeks may be indicated for certain chronic pain patients in whom manipulation is helpful in improving function, decreasing pain and improving quality of life. In these cases, treatment may be continued at 1 treatment every other week until the patient has reached MMI and maintenance treatments have been determined. Extended durations of care beyond what is considered “maximum” may be necessary in cases of re-injury, interrupted continuity of care, exacerbation of symptoms, and in those patients with comorbidities. Such care should be re-evaluated and documented on a monthly basis. Treatment beyond 4-6 visits should be documented with objective improvement in function. Palliative care should be reevaluated and documented at each treatment session. (Colorado, 2006) Injured workers with complicating factors may need more treatment, if documented by the treating physician.




Marijuana

See Cannabinoids.

Massage therapy

Recommended as an option as indicated below. Massage is a passive intervention and is considered an adjunct to other recommended treatment, especially active interventions (e.g., exercise). Scientific studies show contradictory results. Furthermore, many studies lack long-term follow-up. Massage is beneficial in attenuating diffuse musculoskeletal symptoms, but beneficial effects were registered only during treatment. . This lack of long-term benefits could be due to the short treatment period or treatments such as these do not address the underlying causes of pain. (Hasson, 2004) A very small pilot study showed that massage can be at least as effective as standard medical care in chronic pain syndromes. Relative changes are equal, but tend to last longer and to generalize more into psychologic domains. (Walach 2003) The strongest evidence for benefits of massage is for stress and anxiety reduction, although research for pain control and management of other symptoms, including pain, is promising. The physician should feel comfortable discussing massage therapy with patients and be able to refer patients to a qualified massage therapist as appropriate. (Corbin 2005) Massage is an effective adjunct treatment to relieve acute postoperative pain in patients who had major surgery, according to the results of a randomized controlled trial recently published in the Archives of Surgery. (Mitchinson, 2007) The efficacy of massage as a stand-alone and as multimodality treatment is uncertain, according to this Cohrane review. (Haraldsson, 2007) A recent meta-analysis concluded that massage might be beneficial for patients with subacute and chronic non-specific low-back pain, especially when combined with exercises and education. When massage was compared to an inert therapy (sham treatment), massage was superior for pain and function on both short and long-term follow-ups. When massage was compared to other active treatments, massage was similar to exercises, and massage was superior to joint mobilization, relaxation therapy, physical therapy, acupuncture and self-care education. Reflexology on the feet had no effect on pain and functioning. The beneficial effects of massage in patients with chronic low-back pain lasted at least one year after the end of the treatment. In comparing different techniques of massage, acupuncture massage produced better results than classic (Swedish) massage and Thai massage produced similar results to classic (Swedish) massage. (Furlan-Cochrane, 2008) A small controlled study showed that 10 minutes of massage therapy can help repair exercise-induced muscle damage by subduing inflammation and renewing mitochondria, similar to the way NSAIDs work. The findings suggest that the perceived positive effects of massage are a result of an attenuated production of inflammatory cytokines. (Crane, 2012)
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