Topical Analgesics – Compounded [DWC]
Not recommended. There is no evidence that compounding topical medications, such as adding an anti-inflammatory agent to capsaicin, is more efficacious than the single medication. Furthermore, the FDA has issued warnings on the potential dangers of compounding topical medication containing local anesthetics. Exposure to high concentrations of local anesthetics, like those in compounded topical anesthetic creams, can cause grave reactions including seizures and irregular heartbeats. At least two deaths have been connected to compounded topical anesthetic creams. (FDA Advisory 12/05/06)
See Anti-epilepsy drugs (AEDs) for general guidelines, as well as specific Topiramate listing.
Tramadol (Ultram®) is a centrally acting synthetic opioid analgesic. See Opioids. See also Diabetic neuropathy; Opioids for neuropathic pain; & Medications for acute pain (analgesics).
Transcutaneous Electrotherapy [DWC]
Electrotherapy represents the therapeutic use of electricity and is another modality that can be used in the treatment of pain. Transcutaneous electrotherapy is the most common form electrotherapy where electrical stimulation is applied to the surface of the skin. The earliest devices were referred to as TENS (transcutaneous electrical nerve stimulation) and are the most commonly used. It should be noted that there is not one fixed electrical specification that is standard for TENS; rather there are several electrical specifications. Other devices (such as H-wave stimulation (devices), Interferential Current Stimulation, Microcurrent electrical stimulation (MENS devices), RS-4i sequential stimulator, Electroceutical Therapy (bioelectric nerve block), Neuromuscular electrical stimulation (NMES devices), Sympathetic therapy, Dynatron STS) have been designed and are distinguished from TENS based on their electrical specifications to be discussed in detail below. The following individual treatment topics are grouped together under the topic heading, “Transcutaneous Electrotherapy [DWC]” and are intended to allow the users of the chronic pain medical treatment guidelines to compare their benefits and to choose amongst the various transcutaneous electrical stimulation devices.
TENS, chronic pain (transcutaneous electrical nerve stimulation) [ODG]
Not recommended as a primary treatment modality, but a one-month home-based TENS trial may be considered as a noninvasive conservative option, if used as an adjunct to a program of evidence-based functional restoration, for the conditions described below. While TENS may reflect the long-standing accepted standard of care within many medical communities, the results of studies are inconclusive; the published trials do not provide information on the stimulation parameters which are most likely to provide optimum pain relief, nor do they answer questions about long-term effectiveness. (Carroll-Cochrane, 2001) Several published evidence-based assessments of transcutaneous electrical nerve stimulation (TENS) have found that evidence is lacking concerning effectiveness. One problem with current studies is that many only evaluated single-dose treatment, which may not reflect the use of this modality in a clinical setting. Other problems include statistical methodology, small sample size, influence of placebo effect, and difficulty comparing the different outcomes that were measured.
Recommendations by types of pain: A home-based treatment trial of one month may be appropriate for neuropathic pain and CRPS II (conditions that have limited published evidence for the use of TENS as noted below), and for CRPS I (with basically no literature to support use).
Neuropathic pain: Some evidence (Chong, 2003), including diabetic neuropathy (Spruce, 2002) and post-herpetic neuralgia. (Niv, 2005)
Phantom limb pain and CRPS II: Some evidence to support use. (Finsen, 1988) (Lundeberg, 1985)
Spasticity: TENS may be a supplement to medical treatment in the management of spasticity in spinal cord injury. (Aydin, 2005)
Multiple sclerosis (MS): While TENS does not appear to be effective in reducing spasticity in MS patients it may be useful in treating MS patients with pain and muscle spasm. (Miller, 2007)
How it works: TENS consists of an electrical pulse generator connected to skin-surface electrodes that apply stimulation to peripheral nerves at well-tolerated frequencies. Electrodes can either be placed at the site of pain or other locations, using a trial and error methodology. A TENS unit can be varied by amplitude, pulse width (duration) and pulse rate (frequency). The most common applications include (1) high frequency or conventional TENS (40-150 Hz, with a short duration of up to 50 microseconds) and (2) low frequency or acupuncture-like TENS (1-4 Hz at a high stimulus intensity). Other modes of TENS include: (1) brief-intense TENS (>80 Hz); (2) burst TENS (bursts at less than 10 Hz) at high frequency; and (3) modulation TENS. The difference between clinical effectiveness of the modalities has not been well defined. (Koke, 2004)
Recent studies: There has been a recent meta-analysis published that came to a conclusion that there was a significant decrease in pain when electrical nerve stimulation (ENS) of most types was applied to any anatomic location of chronic musculoskeletal pain (back, knee, hip, neck) for any length of treatment. Of the 38 studies used in the analysis, 35 favored ENS over placebo. All locations of pain were included based on the rationale that “mechanism, rather than anatomic location of pain, is likely to be a critical factor for therapy.” The overall design of this study used questionable methodology and the results require further evaluation before application to specific clinical practice. (Johnson, 2007) (Novak, 2007) (Furlan, 2007)
Current Treatment Coverage Guidelines:
- BlueCross BlueShield: TENS is considered investigational for treatment of chronic back pain, chronic pain and post-surgical pain, but is covered for certain members based on CMS rules. (BlueCross BlueShield, 2007)
- CMS: The use of TENS for the relief of acute post-operative pain is covered for 30 days or less (as an adjunct and/or alternative to pharmaceutical treatment). TENS is also covered as treatment for chronic intractable pain. Medicare requires a month-long trial period in order to determine if there is a significant therapeutic effect. (Medicare, 2006)
- Aetna & Humana: consistent with the CMS Guidelines (Aetna, 2005) (Humana, 2004)
- VA: TENS is considered equivocal when compared to other modalities. (US Dept VA, 2001)
- European Federation of Neurological Societies (EFNS): TENS may be better than placebo (level C) although worse than electro-acupuncture (level B); TENS is non-invasive and suitable as a preliminary or add-on therapy. (Cruccu, 2007)
Criteria for the use of TENS:
Chronic intractable pain (for the conditions noted above):
- Documentation of pain of at least three months duration
- There is evidence that other appropriate pain modalities have been tried (including medication) and failed
- A one-month trial period of the TENS unit should be documented (as an adjunct to ongoing treatment modalities within a functional restoration approach) with documentation of how often the unit was used, as well as outcomes in terms of pain relief and function; rental would be preferred over purchase during this trial
- Other ongoing pain treatment should also be documented during the trial period including medication usage
- A treatment plan including the specific short- and long-term goals of treatment with the TENS unit should be submitted
- A 2-lead unit is generally recommended; if a 4-lead unit is recommended, there must be documentation of why this is necessary
Form-fitting TENS device: This is only considered medically necessary when there is documentation that there is such a large area that requires stimulation that a conventional system cannot accommodate the treatment, that the patient has medical conditions (such as skin pathology) that prevents the use of the traditional system, or the TENS unit is to be used under a cast (as in treatment for disuse atrophy)
TENS, post operative pain (transcutaneous electrical nerve stimulation) [ODG]
Recommended as a treatment option for acute post-operative pain in the first 30 days post-surgery. Transcutaneous electrical nerve stimulation (TENS) appears to be most effective for mild to moderate thoracotomy pain. (Solak, 2007) (Erdogan, 2005). It has been shown to be of lesser effect, or not at all for other orthopedic surgical procedures. (Breit, 2004) (Rosenquist 2003) The proposed necessity of the unit should be documented upon request. Rental would be preferred over purchase during this 30-day period.
H-wave stimulation (devices) [ODG]
Not recommended as an isolated intervention, but a one-month home-based trial of H-Wave stimulation may be considered as a noninvasive conservative option for diabetic neuropathic pain, if used as an adjunct to a program of evidence-based functional restoration, and only following failure of other recommended pain modalities. There is no evidence that H-Wave is more effective than TENS despite the significantly higher cost of H-Wave, so TENS would be recommended for the treatment of diabetic neuropathy over H-Wave unless documentation can support medical necessity. While H-Wave and other similar type devices can be useful for pain management, they are often over-prescribed and used as a passive intervention rather than as a tool in combination with functional restoration. For diabetic neuropathy unresponsive to more conventional treatment, a one-month trial may be appropriate to permit the physician and physical therapist to study the effects and benefits, and it should be documented (as an adjunct to ongoing treatment modalities within a functional restoration approach) with documentation of how often the unit was used, as well as outcomes in terms of pain relief and function; rental would be preferred over purchase during this trial. Trial periods of more than one month should be justified by documentation submitted for review. Three small controlled trials provide suggestive evidence about the effectiveness of H-wave electrical stimulation for diabetic neuropathy, but evidence is lacking for other conditions. There are no high quality studies demonstrating the effectiveness of H-Wave for conditions other than diabetic neuropathy. H-wave stimulation is a form of electrical stimulation that differs from other forms of electrical stimulation, such as transcutaneous electrical nerve stimulation (TENS), in terms of its waveform. While physiatrists, chiropractors, or podiatrists may perform H-wave stimulation, H-wave devices are also available for home use. H-wave stimulation is sometimes used for the treatment of pain related to a variety of etiologies, muscle sprains, temporomandibular joint dysfunctions or reflex sympathetic dystrophy. In fact, H-wave is used more often for muscle spasm and acute pain as opposed to neuropathy or radicular pain, since there is anecdotal evidence that H-Wave stimulation helps to relax the muscles, but there are no published studies to support this use, so it is not recommended. H-wave stimulation has also been used to accelerate healing of wounds, such as diabetic ulcers. H-wave electrical stimulation must be distinguished from the H-waves that are a component of electromyography. (Julka, 1998) (Kumar, 1997) (Kumar, 1998) (McDowell, 1999) (McDowell2, 1999) (BlueCross BlueShield, 2005) (Aetna, 2005) (Blum, 2006) (Blum2, 2006)
Interferential Current Stimulation [ODG]
Not generally recommended. The randomized trials that have evaluated the effectiveness of this treatment have included studies for back pain, jaw pain, soft tissue shoulder pain, cervical neck pain and post-operative knee pain. (Van der Heijden, 1999) (Werner, 1999) (Hurley, 2001) (Hou, 2002) (Jarit, 2003) (Hurley, 2004) (CTAF, 2005) The findings from these trials were either negative or non-interpretable for recommendation due to poor study design and/or methodologic issues. In addition, although proposed for treatment in general for soft tissue injury or for enhancing wound or fracture healing, there is insufficient literature to support Interferential current stimulation for treatment of these conditions. There are no standardized protocols for the use of interferential therapy; and the therapy may vary according to the frequency of stimulation, the pulse duration, treatment time, and electrode-placement technique.
How it works: Paired electrodes of two independent circuits carry differing medium-frequency alternating currents so that current flowing between each pair intersects at the underlying target. The frequency allows the Interferential wave to meet low impedance when crossing the skin. Treatments involve the use of two pairs of electrodes and most units allow variation in waveform, stimulus frequency and amplitude or intensity, and the currents rise and fall at different frequencies. It is theorized that the low frequency of the interferential current causes inhibition or habituation of the nervous system, which results in muscle relaxation, suppression of pain and acceleration of healing.
How it is different than TENS: It has been postulated that Interferential stimulation allows for deeper penetration of tissue, whereas TENS is predominantly a cutaneous or superficial stimulus. Interferential current is proposed to produce less impedance in the tissue and the intensity provided is suggested to be perceived as more comfortable. Because there is minimal skin resistance with the interferential current therapy, a maximum amount of energy goes deeper into the tissue. It also crisscrosses, as opposed to the linear application of the TENS. This crisscrossing is postulated to be more effective because it serves to confuse the nerve endings, preventing the treated area from adjusting to the current. There are no published randomized trials comparing TENS to Interferential current stimulation.
Current US treatment coverage recommendations:
California Technology Assessment Forum: The treatment does not meet the CTAF criteria 2-5 for the treatment of musculoskeletal pain. Interferential stimulation did meet the criterion for meeting appropriate regulatory approval. (CTAF, 2005)
Aetna: Considered experimental and investigational for the reduction of pain and edema and all other indications because its effectiveness for these indications has not been established. (Aetna, 2007)
BlueCross BlueShield: Considered investigational/not medically necessary to provide pain relief associated with soft tissue injury, musculoskeletal disorders, or in enhancing wound and fracture healing. (BlueCross BlueShield, 2006)
CMS: Does not directly address the use of Interferential stimulator treatment.
See also Sympathetic therapy. See also TENS, chronic pain.
While not generally recommended, Patient selection criteria if Interferential stimulation is to be used anyway:
Possibly appropriate for the following conditions if it has documented and proven to be effective as applied by a licensed physical therapist:
- 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, etc.).
If those criteria are met, then a one-month trial may be appropriate to permit the physician and physical therapist to study the effects and benefits. There should be evidence of increased functional, 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.
Microcurrent electrical stimulation (MENS devices) [ODG]
Not recommended. Based on the available evidence conclusions cannot be made concerning the effect of Microcurrent Stimulation Devices (MENS) on pain management and objective health outcomes. MENS is characterized by sub-sensory current that acts on the body's naturally occurring electrical impulses to decrease pain and facilitate the healing process. MENS differs from TENS in that it uses a significantly reduced electrical stimulation. TENS blocks pain, while MENS acts on the naturally occurring electrical impulses to decrease pain by stimulating the healing process. (BlueCross BlueShield, 2005)
RS-4i sequential stimulator [ODG]
See Interferential current stimulation (ICS).
Electroceutical Therapy (bioelectric nerve block) [ODG]
Not recommended. Electroceutical therapy (also known as bioelectric nerve block) is experimental and investigational for the treatment of acute pain or chronic pain (e.g., back pain, diabetic pain, joint pain, fibromyalgia, headache, and CRPS) because there is a lack of scientific evidence regarding the effectiveness of this technology. In addition, electroceutical treatments use much higher electrical frequencies than TENS units and may only be prescribed and administered under the supervision of a healthcare provider experienced in this method of treatment. (Aetna, 2005)
Neuromuscular electrical stimulation (NMES devices) [DWC]
Not recommended. NMES is used primarily as part of a rehabilitation program following stroke and there is no evidence to support its use in chronic pain.
Sympathetic therapy [ODG]
Not recommended. Sympathetic therapy is considered investigational. The lack of published outcomes from well-designed clinical trials prohibits scientific conclusions concerning the health outcome effects of sympathetic therapy for the treatment of pain. Sympathetic therapy describes a type of electrical stimulation of the peripheral nerves that is designed to stimulate the sympathetic nervous system in an effort to "normalize" the autonomic nervous system and alleviate chronic pain. Unlike TENS (transcutaneous electrical nerve stimulation) or interferential electrical stimulation, sympathetic therapy is not designed to treat local pain, but is designed to induce a systemic effect on sympathetically induced pain. The Dynatron STS device and a companion home device, Dynatron STS Rx, are devices that deliver sympathetic therapy. These devices received U.S. Food and Drug Administration (FDA) clearance in March 2001 through a 510(k) process. The FDA-labeled indication is as follows: "Electrical stimulation delivered by the Dynatron STS and Dynatron STS Rx is indicated for providing symptomatic relief of chronic intractable pain and/or management of post-traumatic or post-surgical pain." (Werners, 1999) (Washington, 2002) (BlueCross Blue-shield, 2005) (Aetna, 2005)
Dynatron STS [ODG]
See Sympathetic therapy.
Treatment for CRPS
See CRPS, treatment
Trigger point injections
Recommended only for myofascial pain syndrome as indicated below, with limited lasting value. See Myofacial pain. Not recommended for radicular pain. A trigger point is a discrete focal tenderness located in a palpable taut band of skeletal muscle, which produces a local twitch in response to stimulus to the band. Myofascial pain syndrome is a regional painful muscle condition with a direct relationship between a specific trigger point and its associated pain region. These injections may occasionally be necessary to maintain function in those with myofascial problems when myofascial trigger points are present on examination. Not recommended for typical back pain or neck pain. (Graff-Radford, 2004) (Nelemans-Cochrane, 2002) See also the Low Back Chapter. For fibromyalgia syndrome, trigger point injections have not been proven effective. (Goldenberg, 2004)
Criteria for the use of Trigger point injections:
Trigger point injections with a local anesthetic with or without steroid may be recommended for the treatment of chronic low back or neck pain with myofascial pain syndrome when all of the following criteria are met: (1) Documentation of circumscribed trigger points with evidence upon palpation of a twitch response as well as referred pain; (2) Symptoms have persisted for more than three months; (3) Medical management therapies such as ongoing stretching exercises, physical therapy, NSAIDs and muscle relaxants have failed to control pain; (4) Radiculopathy is not present (by exam, imaging, or neuro-testing); (5) Not more than 4 injections per session; (6) No repeat injections unless a greater than 50% pain relief is obtained for six weeks after an injection and there is documented evidence of functional improvement; (7) Frequency should not be at an interval less than two months; (8) Trigger point injections with any substance (e.g., saline or glucose) other than local anesthetic with or without steroid are not recommended.
(Colorado, 2002) (BlueCross BlueShield, 2004)
See Curcumin (Turmeric).
Not recommended. Therapeutic ultrasound is one of the most widely and frequently used electrophysical agents. Despite over 60 years of clinical use, the effectiveness of ultrasound for treating people with pain, musculoskeletal injuries, and soft tissue lesions remains questionable. There is little evidence that active therapeutic ultrasound is more effective than placebo ultrasound for treating people with pain or a range of musculoskeletal injuries or for promoting soft tissue healing. (Robertson, 2001)
Uncaria Tomentosa (Cat's Claw) [DWC]
Uncaria Tomentosa (Cat's Claw) is not recommended for chronic pain.
Recommended as an option in first-line treatment of neuropathic pain. Venlafaxine (Effexor®) is a member of the selective-serotonin reuptake inhibitor class of antidepressants. It has FDA approval for treatment of depression and anxiety disorders. It is off-label recommended for treatment of neuropathic pain, diabetic neuropathy, fibromyalgia, and headaches. The initial dose is generally 37.5 to 75 mg/day with a usual increase to a dose of 75 mg b.i.d or 150 mg/day of the ER formula. The maximum dose of the immediate release formulation is 375 mg/day and of the ER formula is 225 mg/day. It may have an advantage over tricyclic antidepressants due to lack of anticholenergic side effects. Dosage requirements are necessary in patients with hepatic and renal impairment. (Namaka, 2004) See also Antidepressants for neuropathic pain.
Not recommended. Note: Pulled from market 10/5/04. See Anti-inflammatory medications and NSAIDs (non-steroidal anti-inflammatory drugs). Recent studies have shown an increase in the risk of myocardial infarction for rofecoxib (Vioxx), compared to NSAID’s with an antiplatelet effect. (Choi, 2004) (Solomon, 2004)
Weaning of Medications
Recommended as indicated below. For opioids a slow taper is recommended. The longer the patient has taken opioids, the more difficult they are to taper. The process is more complicated with medical comorbidity, older age, female gender, and the use of multiple agents. Gradual weaning is recommended for long-term opioid users because opioids cannot be abruptly discontinued without probable risk of withdrawal symptoms. (Benzon, 2005) Patients with complex conditions with multiple comorbidities (including psych disorders) should be referred to an addiction medicine/psychiatry specialist. Opioid weaning should include the following: (a) Start with a complete evaluation of treatment, comorbidity, psychological condition, (b) Clear written instructions should be given to the patient and family, (c) If the patient can not tolerate the taper, refer to an expert (pain specialist, substance abuse specialist), (d) Taper by 20 to 50% per week of original dose for patients who are not addicted (the patient needs 20% of the previous day’s dose to prevent withdrawal), (e) Greater success may occur when the patient is switched to longer-acting opioids and then tapered, (f) Office visits should occur on a weekly basis, (g) Assess for withdrawal using a scale such as the Subjective Opioid Withdrawal Scale (SOWS) and Objective Opioid Withdrawal Scale (OOWS), and (h) Recognize that this may take months. For benzodiazepines, tapering is required if used for greater than 2 weeks. (Benzon, 2005) (Ashton, 2005) This is more dangerous than opioid withdrawal, and takes more time, with the following recommendations: (1) The recommended rate of tapering is about 1/8 to 1/10 of the daily dose every 1 to 2 weeks, (2) Rate of withdrawal should be individually tapered, (3) Tapering may take as long as a year, (4) High-dose abusers or those with polydrug abuse may need in-patient detoxification, and (5) Withdrawal can occur when a chronic user switches to a benzodiazepine with a different receptor activity. (Lee, 2002) For carisoprodol (Soma®), this medication is metabolized to meprobamate, a barbiturate. At the highest levels of barbiturate tolerance, the patient is at risk of delirium, seizures or even death with abrupt discontinuation. (Heacock, 2004) (Washington, 2002) See also Detoxification; & Rapid detox.
White willow bark [DWC]
White willow bark is not recommended for chronic pain.
Recommended as an option only for select, highly motivated patients. There is considerable evidence of efficacy for mind-body therapies such as yoga in the treatment of chronic pain. Also, the impact on depression and disability could be considered as important outcomes for further study. Since outcomes from this therapy are very dependent on a highly motivated patient, we recommend approval where requested by a specific patient, but not adoption for use by any patient. (Astin, 2003) (Barrows, 2002) (Galantino, 2004)
Recommended for use after there is evidence of a failure of a trial of intrathecal morphine and dilaudid, and only in individuals for whom the potential benefits outweigh the risks of serious neuropsychiatric adverse effects. The 2007 Polyanalgesic Consensus Conference Recommendations for the Management of Pain by Intrathecal Drug Delivery concluded that ziconotide should be updated to a first-line intrathecal drug.
Ziconotide (Prialt®) is a synthetic calcium channel blocker that is delivered intrathecally, offering a non-opioid option for treatment of chronic pain, and possibly, spasticity associated with spinal cord trauma. It is FDA-approved for the management of severe chronic pain in patients for whom intrathecal therapy is warranted and who are intolerant of other treatments, such as systemic analgesics, adjunctive therapies, or other first-line treatment. This medication is meant to be an option for patients who are intolerant and/or refractory to intrathecal morphine. The advantage of the medication is that it is considered non-addictive. Current case reports have described many challenges in converting from morphine to ziconotide, including inadequate analgesia, adverse medication effects, and opioid withdrawal symptoms. An option for treatment is combining ziconotide with other currently available intrathecal medications, although this has not been studied in placebo-controlled trials.
Adverse effects: Prialt has been associated with severe CNS-related adverse effects, and a “black-box” warning has been issued in this regard. Neurological warnings include hallucinations, paranoid ideation, hostility, delirium, psychosis, manic reactions and decreased alertness. Certain patients may be at increased risk for psychiatric side effects including those with pre-existing history of depression with risk of suicide and patients with pre-existing psychosis. Cognitive impairment was noted in approximately 30% of patients in clinical trials, and this symptom was found to be reversible within about two weeks of discontinuation. Prialt is contraindicated in patients with a pre-existing history of psychosis. Prialt can be discontinued abruptly without evidence of withdrawal effects in the presence of serious adverse events.
Dosage requirements: The current recommendations suggested by the manufacturer for this medication include a low initial infusion rate (0.1 mcg/hour for a total of 2.4 mcg/day) and limiting infusion increases to 2-3 times a week. Current drug trials have evaluated the efficacy of the medication for a 3-week duration only, but preliminary trials suggested that analgesic efficacy would be maintained long-term in open label trials.
Post-marketing dose recommendations: Post-marketing, an expert consensus-panel recommended a starting dose of 0.5 mcg/24 hours with upward titration of no more than 0.5 mcg/week due to increased risk of adverse effects with higher doses. (Fisher, 2005)
Filling intervals: The reservoir should be refilled initially at 14 days and at 40-day intervals thereafter if the drug is diluted (60 days if undiluted).
Other precautions: This medication is associated with elevation of serum creatinine kinase, with risk factors including male gender and concomitant use of anti-depressants, anti-convulsants and intrathecal morphine. This lab value should be monitored at least bi-weekly for the first month and at monthly intervals thereafter. Symptoms of myalgia include myasthenia, muscle cramps and unusual fatigue. (Thompson, 2006) (Wermeling 2005) (Lyseng-Williamson, 2006) (Lynch, 2006) (Deer, 2007) (Rauck, 2006) See Intrathecal drug delivery systems, medications.
See Anti-epilepsy drugs (AEDs) for general guidelines, as well as specific Zonisamide listing.
Proposed Chronic Pain Medical Treatment Guidelines 8 C.C.R. §§9792.20 – 9792.26
Medical Treatment Utilization Schedule (June 2008) Page of