Contents part 1: Introduction




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Proximal Diabetic Neuropathy (also referred to as Diabetic Amyotrophy, or Diabetic Lumbosacral Radiculoplexus Neuropathy, or Diabetic Polyradiculopathy): (Bansal, 2006) Symptoms are consistent with proximal nerve involvement and include pain in the low back, hip and/or anterior thigh, which can be unilateral or bilateral. Thoracic radiculopathy may be involved as well as upper limb involvement (the latter mostly being mononeuropathies). The onset may be abrupt or chronic. Weight loss is also common. Pain and weakness is frequently persistent. This condition can coexist with distal symmetrical polyneuropathy. EMG/NCV shows reductions in the compound muscles and SNAPs with mild slowing of the NCVs. EMGs also show frequent fibrillation potentials (including lumbosacrals). This condition is considered under recognized and has been confused with radiculopathy secondary to disc disease. (Dyck, 2001)

Limb Neuropathy: Secondary to nerve infarction. (Bansal, 2006) When associated with nerve infarction, there is an acute onset, with eventual weakness and atrophy. The most common nerves are median, ulnar and peroneal. (Wiffen-Cochrane, 2005)

Entrapment: more common. Electrodiagnostic testing shows segmental nerve conduction slowing. A common presentation is carpal tunnel syndrome (3 times more common in diabetics). (Bansal, 2006) Other frequent presentations include the ulnar, radial, lateral femoral cutaneous, peroneal, medial and lateral plantar nerves.


Nerve conduction studies in DN: 1) Large Fiber Neuropathies: Motor nerve conduction is affected but is often insensitive. The diagnosis is generally made by excluding other causes of neuropathy. Entrapment is common and usually shows unilateral NCV changes. Overall, even in subclinical states, NCV is gradually diminished, and there can be evidence of decreased amplitude of evoked muscles or nerve action potentials (decreased sensory and motor amplitudes). (Bansal, 2006) 2) Small Fiber Neuropathies: Small fiber function is not detectable using standard electrophysiologic measures.

Treatment: The number needed to treat for different drugs for 50% pain relief include: 1) tricyclic antidepressants, 1.4; 2) dextromethorphan, 1.9; 3) carbamazepine 3.3; 4) Tramadol 3.4; 5) gabapentin, 4.3 (Wiffen-Cochrane, 2005) (increased from 3.7 in the latest Cochrane review); 6) capsaicin 5.9; 7) SSRIs, 6.7. (Sindrup, 1999) It is advised to avoid opioids due to possible addiction. The FDA has approved the use of pregabalin (Lyrica®) for the treatment of DM. See also Duloxetine (Cymbalta®).

Diagnostic criteria for CRPS

See CRPS, diagnostic criteria.

Diazepam (Valium)

Not recommended. See Benzodiazepines.

Diclofenac

Not recommended as first line due to increased risk profile. A large systematic review of available evidence on NSAIDs confirms that diclofenac, a widely used NSAID, poses an equivalent risk of cardiovascular events to patients as did rofecoxib (Vioxx), which was taken off the market. According to the authors, this is a significant issue and doctors should avoid diclofenac because it increases the risk by about 40%. For a patient who has a 5% to 10% risk of having a heart attack, that is a significant increase in absolute risk, particularly if there are other drugs that don't seem to have that risk. For people at very low risk, it may be an option. (McGettigan, 2011) Another meta-analysis supported the substantially increased risk of stroke with diclofenac, further suggesting it not be a first-line NSAID. (Varas-Lorenzo, 2011) In this nationwide cohort study the traditional NSAID diclofenac was associated with the highest increased risk of death or recurrent myocardial infarction (hazard ratio, 3.26; 95% confidence interval, 2.57 to 3.86 for death/MI at day 1 to 7 of treatment) in patients with prior MI, an even higher cardiovascular risk than the selective COX-2 inhibitor rofecoxib, which was withdrawn from the market due to its unfavorable cardiovascular risk profile. (Schjerning, 2011) According to FDA MedWatch, postmarketing surveillance of topical diclofenac has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation. If using diclofenac then consider discontinuing as it should only be used for the shortest duration possible in the lowest effective dose due to reported serious adverse events. Post marketing surveillance has revealed that treatment with all oral and topical diclofenac products may increase liver dysfunction, and use has resulted in liver failure and death. Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac. (FDA, 2011) In 2009 the FDA issued warnings about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium. (FDA, 2009) With the lack of data to support superiority of diclofenac over other NSAIDs and the possible increased hepatic and cardiovascular risk associated with its use, alternative analgesics and/or nonpharmacological therapy should be considered. The AGS updated Beers criteria for inappropriate medication use includes diclofenac. (AGS, 2012) Diclofenac is associated with a significantly increased risk of cardiovascular complications and should be removed from essential-medicines lists, according to a new review. The increased risk with diclofenac was similar to Vioxx, a drug withdrawn from worldwide markets because of cardiovascular toxicity. Rofecoxib, etoricoxib, and diclofenac were the three agents that were consistently associated with a significantly increased risk when compared with nonuse. With diclofenac even in small doses it increases the risk of cardiovascular events. They recommended naproxen as the NSAID of choice. (McGettigan, 2013) See also 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. See also Zorvolex (diclofenac).

Diclofenac potassium (Cataflam®)

Not recommend diclofenac as first line due to increased risk profile. See Diclofenac listing. See also 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 Diclofenac Potassium (Cataflam®) listing for more information and references.

Diclofenac sodium (Voltaren®, Voltaren-XR®)

Not recommend diclofenac as first line due to increased risk profile. See Diclofenac listing. See also 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 Diclofenac Sodium (Voltaren®, Voltaren-XR®) listing for more information and references, where the oral form had been recommended with cautions. See also Topical analgesics, where Voltaren Gel is recommended for osteoarthritis after failure of an oral NSAID, or contraindications to oral NSAIDs, or for patients who cannot swallow solid oral dosage forms.

Diclofenac, topical (Flector®, Pennsaid®, Voltaren® Gel)

Not recommended as a first-line treatment, but recommended as an option for patients at risk of adverse effects from oral NSAIDs, after considering the increased risk profile with diclofenac. See specific topical diclofenac listings: Flector® patch (diclofenac epolamine); Pennsaid® (diclofenac sodium topical solution); & Voltaren® Gel (diclofenac). For more details, see also Topical analgesics, Non-steroidal antinflammatory agents (NSAIDs), and the diclofenac topical listing.

Diflunisal (Dolobid®)

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 Diflunisal (Dolobid®) listing for more information and references.

DMSO (dimethylsulfoxide)

See CRPS, medications.

DNA testing

See Cytokine DNA testing.

Dona™ glucosamine sulfate

See Glucosamine (and Chondroitin Sulfate).


Dorsal column stimulators

See Spinal Cord Stimulators (SCS).

Dronabinol (Marinol)

Dronabinol is a synthetic THC (tetrahydrocannabinol). See Cannabinoids.

Drug testing

For more information, see See DWC “Guideline for the Use of Opioids to Treat Work-Related Injuries,” for recommendations on urine drug testing.


Drug therapy

See Medications.

Dry needling

The term dry needling, using solid needles for therapy, without an injectable liquid, is used in the context of acupuncture, trigger point injections, or percutaneous needle tenotomy. See Acupuncture or Trigger point injections (TPIs) in this Chronic Pain guideline or DWC MTUS Acupuncture Medical Treatment Guidelines.

Duexis® (ibuprofen & famotidine)

Not recommended as as a first-line drug. Horizon Pharma recently announced the launch of Duexis, a combination of ibuprofen 800 mg and famotidine 26.6 mg, indicated for rheumatoid arthritis and osteoarthritis. (FDA, 2012) Ibuprofen (eg, Motrin, Advil) and famotidine (eg, Pepcid) are also available in multiple strengths OTC, and other strategies are recommended to prevent stomach ulcers in patients taking NSAIDS. See NSAIDs, GI symptoms & cardiovascular risk, where Proton pump inhibitors (PPIs) are recommended. With less benefit and higher cost, using Duexis as a first-line therapy is not justified.

Duloxetine (Cymbalta®)

Recommended as an option in first-line treatment of neuropathic pain. Duloxetine (Cymbalta®) is a norepinephrine and serotonin reuptake inhibitor antidepressant (SNRIs). It has FDA approval for treatment of depression, generalized anxiety disorder, and for the treatment of pain related to diabetic neuropathy, with effect found to be significant by the end of week 1 (effect measured as a 30% reduction in baseline pain). The starting dose is 20-60 mg/day, and no advantage has been found by increasing the dose to twice a day, except in fibromyalgia. The medication has been found to be effective for treating fibromyalgia in women with and without depression, 60 mg once or twice daily. (Arnold, 2005) The most frequent side effects include nausea, dizziness and fatigue. GI symptoms are more common early in treatment. The side effect profile of Duloxetine is thought to be less bothersome to patients than that of tricyclic antidepressants. Note: On October 17, 2005, Eli Lilly and the U.S. Food and Drug Administration (FDA) notified healthcare professionals of revision to the PRECAUTIONS/Hepatotoxicity section of the prescribing information for Cymbalta. Postmarketing reports of hepatic injury (including hepatitis and cholestatic jaundice) suggest that patients with preexisting liver disease who take duloxetine may have an increased risk for further liver damage. The new labeling extends the Precaution against using Cymbalta in patients with substantial alcohol use to include those patients with chronic liver disease. It is recommended that Cymbalta not be administered to patients with hepatic insufficiency. See Antidepressants for chronic pain for general guidelines, as well as specific Duloxetine listing for more information and references. On June 13, 2008, the FDA approved a new indication for duloxetine HCl delayed-release capsules (Cymbalta®; Eli Lilly and Company) for the management of fibromyalgia in adults. The FDA notes that although duloxetine was effective for reducing pain in patients with and without major depressive disorder, the degree of pain relief may have been greater in those with comorbid depression. Treatment of fibromyalgia with duloxetine should be initiated at 30 mg/day for 1 week and then uptitrated to the recommended 60-mg dose. (Waknine, 2008) Note: This drug was recently included in a list of 20 medications identified by the FDA's Adverse Event Reporting System, that are under FDA investigation. (FDA, 2008) An FDA panel broadened the indication to include the treatment of chronic pain. (FDA, 2010) Regulatory approval followed a positive vote regarding the use of duloxetine to treat chronic low back pain, but the committee did not express the same confidence in the drug's usefulness as a treatment for osteoarthritis. Despite this, duloxetine has been approved for both chronic low back pain and osteoarthritis. The recommended dose is 60 mg daily. Duloxetine delayed-release capsules previously were approved for the treatment of major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, and fibromyalgia. (FDA2, 2010) See DWC MTUS chapter on Low Back Complaints.

Duragesic® (fentanyl transdermal system)



Duragesic is the trade name of a fentanyl transdermal therapeutic system, which releases fentanyl, a potent opioid, slowly through the skin. It is manufactured by ALZA Corporation and marketed by Janssen Pharmaceutica (both subsidiaries of Johnson & Johnson). The FDA-approved product labeling states that Duragesic is indicated in the management of chronic pain in patients who require continuous opioid analgesia for pain that cannot be managed by other means. Due to the significant side effects, not for use in routine musculoskeletal pain. The FDA will require color changes to the writing that appears on fentanyl pain patches (Duragesic and generics) so they can be seen more easily and to emphasize that unintended exposure can cause death. (FDA, 2013) This is part of an effort to prevent accidental exposure to the patches, which can cause serious harm and death in children, pets, and others. (FDA, 2013) See Fentanyl.

Dynatron STS

See Sympathetic therapy.

Dysport

See Botulinum toxin.

Ear-acupuncture

See Auricular electroacupuncture.

Education

Recommended. On-going education of the patient and family, as well as the employer, insurer, policy makers and the community should be the primary emphasis in the treatment of chronic pain. Currently, practitioners often think of education last, after medications, manual therapy and surgery. Practitioners must develop and implement an effective strategy and skills to educate patients, employers, insurance systems, policy makers and the community as a whole. An education-based paradigm should always start with inexpensive communication providing reassuring information to the patient. More in-depth education currently exists within a treatment regime employing functional restorative and innovative programs of prevention and rehabilitation. No treatment plan is complete without addressing issues of individual and/or group patient education as a means of facilitating self-management of symptoms and prevention. (Colorado, 2002) An educational technique known as the Alexander technique, along with exercise, offers an individualized approach designed to develop lifelong skills for self-care that help people avoid poor habits affecting posture and neuromuscular coordination. An accompanying editorial notes that the results of this study may not apply to clinical practice. In addition, in the US there are few instructors trained in this technique. (Little, 2008) An RCT with 1,077 patients using education and guidelines-based clinical management compared to standard primary care management, found that the program improved short- and long-term work disability outcomes and was cost-effective. Fewer patients received long-term disability compensation in the intervention group than in the control group, and lost-work episodes were shorter in the intervention group than in the control group. Each dollar invested generated a benefit of 11 dollars. (Abásolo, 2005)

Edluar (zolpidem tartrate)

In late 2009 the FDA approved Edluar (zolpidem tartrate) sublingual tablets, 5 and 10 mg for the treatment of insomnia. This new formulation of the zolpidem (Ambien) tablets does not appear to have any therapeutic benefit over existing generic zolpidem. (FDA, 2010) See Zolpidem (Ambien®).

Effexor® (venlafaxine)

Effexor® is the brand name for venlafaxine, and it is supplied by Wyeth Pharmaceuticals Inc. Venlafaxine is an antidepressant in the class called Selective serotonin and norepinephrine reuptake inhibitors (SNRIs). See Venlafaxine (Effexor®).

Electrical stimulators (E-stim)

See more specific therapy. The following are choices: Galvanic stimulation, H-wave stimulation (devices), Interferential current stimulation (ICS), Microcurrent electrical stimulation (MENS devices), Neuroreflexotherapy, Neuromuscular electrical stimulation (NMES), Percutaneous electrical nerve stimulation (PENS), Percutaneous neuromodulation therapy (PNT), Spinal cord stimulation, Sympathetic therapy, Electroceutical therapy (bioelectric nerve block), Transcutaneous electrical neurostimulation (TENS); & Scrambler therapy (Calmare®).

Electroceutical therapy (bioelectric nerve block)

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)

Embeda® (morphine /naltrexone)



This medication is designed to alter oral use and thus prevent patients from abusing opioids. As it is resistant to being crushed or dissolved, Embeda does not allow for nasal use (insufflation), chewing and /or intravenous use. Other tamper-resistant agents on the market include Suboxone (buprenorphine/ naloxone), Opana (oxymorphone), Exalgo (hydromorphone), and OxyContin (oxycodone controlled release). The FDA has approved morphine sulfate and naltrexone hydrochloride extended-release capsules (Embeda) for once- or twice-daily use in the management of moderate to severe pain when continuous, around-the-clock opioid analgesic therapy is warranted for an extended period. The capsules contain morphine pellets with a sequestered inner core of the opioid antagonist naltrexone that is released when the product is crushed or chewed, thereby discouraging tampering and drug abuse. Approval of the product was based on data from 12 clinical studies, including a phase 3 study showing that its use provided significant pain relief compared with placebo in patients with severe pain caused by osteoarthritis of the hip or knee. (FDA, 2009) In this RCT pain relief was statistically significantly superior for those treated with Embeda compared to the control group (Trevino, 2009) The FDA's latest list of drugs to monitor after having identified potential signs of serious risks or new safety information includes Embeda for withdrawal symptoms not associated with misuse. (FDA, 2011) Black Box Warning: Embeda is not intended for PRN use. Embeda can be abused in a manner similar to other opioid agonists. It is only recommended for opioid tolerant patients. Patients on this drug should not ingest alcohol, including that included in prescription and non-prescription medications. Fatal respiratory depression can occur with use.

Epidiolex™ (cannabidiol)

Epidiolex is an oral liquid that contains plant-derived cannabidiol without THC for use in the treatment of intractable epilepsy. See Cannabinoids.

Epidural steroid injections (ESIs)

Refer to DWC MTUS chapter on Low Back Complaints for recommendations.

Escitalopram (Lexapro®)

See Anxiety medications in chronic pain, Escitalopram (Lexapro®) listing, and Antidepressants for chronic pain, SSRIs

Estazolam

Not recommended. See Benzodiazepines.

Eszopicolone (Lunesta)

Not recommended for long-term use, but recommended for short-term use.

Etodolac (Lodine®, Lodine XL®)

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 Etodolac (Lodine®, Lodine XL®) listing for more information and references. A large systematic review of available evidence on NSAIDs confirms that naproxen and low-dose ibuprofen are least likely to increase cardiovascular risk. Etodolac in the unpaired analyses had a risk profile similar to that of rofecoxib, but the pair-wise analyses are likely to be less confounded, and these analyses showed etodolac to be similar to two low risk drugs, ibuprofen and naproxen. (McGettigan, 2011)

Evzio (naloxone)

See Naloxone (Narcan®).

Exalgo (hydromorphone)

Exalgo (hydromorphone) is a once-a-day extended release opioid formulation for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time, with an FDA black box warning.

Exercise

Recommended. There is strong evidence that exercise programs, including aerobic conditioning and strengthening, are superior to treatment programs that do not include exercise. There is no sufficient evidence to support the recommendation of any particular exercise regimen over any other exercise regimen. A therapeutic exercise program should be initiated at the start of any treatment or rehabilitation program, unless exercise is contraindicated. Such programs should emphasize education, independence, and the importance of an on-going exercise regime. (State, 2002) (Airaksinen, 2006) A recent study of the long-term impact of aerobic exercise on musculoskeletal pain, in a prospective cohort of 866 healthy seniors followed for 14 years, found that exercise was associated with a substantial and significant reduction in pain even after adjusting for gender, baseline BMI and attrition, and despite the fact that fractures, a significant predictor of pain, were slightly more common among exercisers. (Bruce, 2005) A recent trial concluded that active physical treatment, cognitive-behavioral treatment, and the two combined each resulted in equally significant improvement, much better compared to no treatment. (The cognitive treatment focused on encouraging increased physical activity.) (Smeets, 2006) Progressive walking, simple strength training, and stretching improved functional status, key symptoms, and self-efficacy in patients with fibromyalgia. (Rooks, 2007) Physical conditioning in chronic pain patients can have immediate and long-term benefits, according to a low-quality study presented at the American Academy of Pain Medicine 24th Annual Meeting. (Burleson, 2008) Physical therapy in warm-water has been effective and highly recommended in persons with fibromyalgia. In this RCT, an aquatic exercise program including one-hour, supervised, water-based exercise sessions, three times per week for 8 months, was found to be cost-effective in terms of both health care costs and societal costs. (Gusi, 2008) A meta-analysis concluded that there is gold level evidence that supervised aerobic exercise training has beneficial effects on physical capacity and fibromyalgia syndrome (FMS) symptoms, and strength training may also have benefits on some FMS symptoms. (Busch-Cochrane, 2007)

Facet blocks

Recommend no more than one therapeutic intra-articular lumbar block when facet joint pain is suspected, but not cervical blocks. Recommend no more than one set of medial branch diagnostic blocks prior to facet neurotomy, but not recommend medial branch blocks except as a diagnostic tool. Not recommend a multiple series of facet joint injections. Not recommend thoracic facet joint injections. Refer to the DWC MTUS chapters on Low Back Complaints as well as Neck and Upper Back Complaints for detailed information.

Fenoprofen (Nalfon®)

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 Fenoprofen (Nalfon®) listing for more information and references.

Fentanyl

Refer to the DWC “Guideline for the Use of Opioids to Treat Work-Related Injuries” for recommendations on the use of opioids such as fentanyl. Fentanyl is an opioid analgesic with a potency eighty times that of morphine. Weaker opioids are less likely to produce adverse effects than stronger opioids such as fentanyl. The FDA has approved an immediate-release transmucosal tablet formulation of fentanyl (Abstral; ProStraken, Inc) for the management of breakthrough cancer pain. Because Abstral is subject to abuse and misuse, the product was approved with a risk evaluation and mitigation strategy (REMS) that includes a restricted distribution program requiring registration of prescribers, pharmacies, and patients. (FDA, 2011)

Fentora® (fentanyl effervescent buccal tablet)



Fentora is an opioid painkiller currently approved for the treatment of breakthrough pain in certain cancer patients. Cephalon had applied to the FDA for approval to market the drug for patients with other pain conditions such as chronic low back pain and chronic neuropathic pain, but approval was not obtained. Refer to the DWC “Guideline for the Use of Opioids to Treat Work-Related Injuries” for recommendations on the use of opioids.

Fibromyalgia syndrome (FMS)

Overview of this pain syndrome (not a procedure): Despite the chronicity and complexity of fibromyalgia syndrome (FMS), there are pharmacological and nonpharmacological interventions available that have clinical benefit. Based on current evidence, a stepwise program emphasizing education, certain medications, exercise, cognitive therapy, or all 4 should be recommended. Current evidence suggests efficacy of low-dose tricyclic antidepressants, cardiovascular exercise, cognitive behavioral therapy, and patient education. A number of other commonly used FMS therapies, such as trigger point injections, have not been adequately evaluated. (Goldenberg-JAMA, 2004) Definitions: Criteria for the classification of Fibromyalgia: (1) History of widespread pain. (2) Pain in 11 of 18 tender point sites on digital palpation. For classification purposes, patients will be said to have fibromyalgia if both criteria are satisfied. Widespread pain must have been present for at least 3 months. The presence of a second clinical disorder does not exclude the diagnosis of fibromyalgia, but fibromyalgia is a controversial & self-perpetuating diagnosis - screen for related conditions & return to regular activities as soon as possible. (Wolfe, 1990) Although the American College of Rheumatology (ACR) criteria for fibromyalgia are used to identify individuals with both widespread pain and tenderness, individuals who meet these criteria are not a homogeneous group. There are three distinct subgroups of patients with fibromyalgia. There appears to be a group of fibromyalgia patients who exhibit extreme tenderness but lack any associated psychological/cognitive factors, an intermediate group who display moderate tenderness and have normal mood, and a group in whom mood and cognitive factors may be significantly influencing the symptom report. (Giesecke, 2003) For fibromyalgia, there is limited evidence of the effectiveness of amitryptiline. (Moulin, 2001) In treating pain associated with fibromyalgia, gabapentin-treated patients displayed a significantly greater improvement in their average pain severity score. (Arnold, 2007) In June 2007 FDA announced the approval of pregabalin (Lyrica®) as the first approved treatment for fibromyalgia. Two double-blind, controlled clinical trials, involving about 1,800 patients, supported approval for use in treating fibromyalgia with doses of 300 milligrams or 450 milligrams per day. (FDA, 2007) Progressive walking, simple strength training, and stretching improved functional status, key symptoms, and self-efficacy in women with fibromyalgia actively treated with medication, according to the results of a randomized controlled trial reported in the November 12 issue of the Archives of Internal Medicine. The benefits of exercise are enhanced when combined with targeted self-management education. (Rooks, 2007) On June 13, 2008, the FDA approved a new indication for duloxetine HCl delayed-release capsules (Cymbalta®; Eli Lilly and Company), allowing their use for the management of fibromyalgia in adults. Previously, only pregabalin (Lyrica®; Pfizer, Inc) was approved to treat this painful condition. The FDA notes that although duloxetine was effective for reducing pain in patients with and without major depressive disorder, the degree of pain relief may have been greater in those with comorbid depression. Treatment of fibromyalgia with duloxetine should be initiated at 30 mg/day for 1 week and then uptitrated to the recommended 60-mg dose. (Waknine, 2008) This meta-analysis concluded that there is gold level evidence that supervised aerobic exercise training has beneficial effects on physical capacity and fibromyalgia syndrome (FMS) symptoms, and strength training may also have benefits on some FMS symptoms. (Busch-Cochrane, 2007) Obesity is linked to an increased risk for fibromyalgia. Women who reported exercising 4 times per week had a 29% lower risk of FM [fibromyalgia] compared with inactive women. Women who reported the highest exercise level had a relative risk (RR) of 0.77 for the development of fibromyalgia, and there was a weak dose-response association between level of physical exercise and the risk for fibromyalgia. Compared with normal-weight women, overweight or obese women had a 60% to 70% higher risk for fibromyalgia. BMI was an independent risk factor for fibromyalgia. Compared with normal-weight women who exercised at least 1 hour per week, overweight or obese women with a similar activity level had a 72% higher risk for fibromyalgia, whereas overweight or obese women who exercised less than 1 hour per week or who were inactive had more than double the risk for fibromyalgia. (Mork, 2010) Tai chi may be a helpful intervention for patients with fibromyalgia. (Wang, 2010) Women with fibromyalgia can reduce symptoms of the disease and improve their function by practicing the mind-body techniques of yoga, a new RCT concludes. The results suggested that yoga led to a beneficial shift in how patients cope with pain, including greater use of adaptive pain-coping strategies, such as engaging in activities despite pain, acceptance of their condition, the use of religion as a coping mechanism, and the ability to relax. (Carson, 2010) In the latest American College of Rheumatology diagnostic criteria for fibromyalgia, the most important diagnostic variables were a widespread pain index (a measure of the number of painful body regions) and categorical scales for cognitive symptoms, unrefreshed sleep, fatigue, and number of somatic symptoms. (Wolfe, 2010) A program aimed at easing stress with meditation and yoga may not be much help for patients with fibromyalgia, a recent RCT suggests. (Schmidt, 2011) Vagus nerve stimulation may show early promise in fibromyalgia. The study included 14 adult women who had physician-diagnosed fibromyalgia for at least 2 years and were refractory to conventional pharmacological treatment (ie, nonsteroidal anti-inflammatories, tricyclic antidepressants, and anticonvulsants). They were surgically implanted with a vagus nerve stimulation (VNS) device. The results may represent a placebo effect related to being in a treatment trial necessitating surgery, feeling a sensory stimulus throughout the day and having high hopes for a good therapeutic outcome. (Lange, 2011) Low doses of the muscle relaxant cyclobenzaprine, taken at bedtime, may help people with fibromyalgia sleep better and feel less pain, according to a small study. Pain declined 26% in the drug group over the study, only 18% more than in the placebo group. (Lederman, 2011) In this study trazodone significantly improved fibromyalgia severity and associated symptomatology. Its combination with pregabalin potentiated this improvement and the tolerability of the drugs in association was good. (Calandre, 2011)

Fioricet

Not recommended. See Barbiturate-containing analgesic agents (BCAs).

Flavocoxid (Limbrel)

Not recommended for treatment of chronic pain. See Limbrel (flavocoxid / arachidonic acid).

Flector® patch (diclofenac epolamine)

Not recommended as a first-line treatment. See the Diclofenac listing, where topical diclofenac is recommended for osteoarthritis after failure of an oral NSAID or contraindications to oral NSAIDs, after considering the increased risk profile with diclofenac, including topical formulations. Flector patch is FDA indicated for acute strains, sprains, and contusions. (FDA, 2007) On 12/07/09 the FDA issued warnings about the potential for elevation in liver function tests during treatment with all products containing diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac. (FDA, 2009) The efficacy in clinical trials for topical NSAIDs has been inconsistent and most studies are small and of short duration. Topical NSAIDs have been shown in meta-analysis to be superior to placebo during the first 2 weeks of treatment for osteoarthritis, but either not afterward, or with a diminishing effect over another 2-week period. These medications may be useful for chronic musculoskeletal pain, but there are no long-term studies of their effectiveness or safety. In addition, there is no data that substantiate Flector efficacy beyond two weeks. See also Topical analgesics, Non-steroidal antinflammatory agents (NSAIDs), and the diclofenac topical listing.

Flexeril® (Cyclobenzaprine)

See Cyclobenzaprine (Flexeril®).

Fluoxetine

See SSRIs (selective serotonin reuptake inhibitors).

Flurazepam

Not recommended. See Benzodiazepines.

Flurbiprofen (Ansaid®)

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 Flurbiprofen (Ansaid®) listing for more information and references. For topical use, see Topical analgesics, Non-steroidal antinflammatory agents (NSAIDs).

Fluvoxamine

See SSRIs (selective serotonin reuptake inhibitors).

FMRI (functional magnetic resonance imaging)

See Functional imaging of brain responses to pain; & Functional MRI.

Functional imaging of brain responses to pain

Not recommended except in research settings. Functional neuroimaging is helping to identify the sensory and emotional components of pain and its autonomic responses, and may help in the design of more rational treatments for pain. Specifically, functional magnetic resonance imaging (fMRI) may have an important role in improved therapeutic approaches to pain. Physiological studies of pain have found numerous regions of the brain to be involved in the interpretation of the 'pain experience'; studies in chronic pain conditions have identified a significant CNS component; and fMRI studies of surrogate models of chronic pain are also being used to further this understanding. (Peyron, 2000) (Mackey, 2004) (Borsook, 2006) (Prager, 2007) Conditions such as depression, anxiety, sleep disturbances, and decision-making difficulties, which affect the quality of life of chronic pain patients as much as the pain itself, may be directly related to altered brain function as a result of chronic pain. (Baliki, 2008) In this study functional magnetic resonance imaging (fMRI) combined with support vector machine (SVM) algorithms accurately predicted thermal pain 81% of the time in healthy subjects. (Brown, 2011) There is a distinct neurologic pattern on functional MRI (fMRI) that is specific to heat-induced pain and sensitive to the analgesic effects of opioids. This nociceptive pain signature could be used to confirm pain in those who cannot report accurately (eg, the very old, very young, cognitively impaired) or whose reports are not completely trusted by medical or legal decision-makers, but it should not be used as a pain lie detector because some individuals may have real pain that is not captured by this pattern. The authors conclude that more study is needed. (Wager, 2013)

Functional improvement measures



Recommended. See DWC “Guideline for the Use of Opioids to Treat Work-Related Injuries” (Clinically Meaningful Improvement in Pain and Function). The importance of an assessment is to have a measure that can be used repeatedly over the course of treatment to demonstrate improvement of function, or maintenance of function that would otherwise deteriorate. It should include the following categories:

Work Functions and/or Activities of Daily Living, Self Report of Disability (e.g., walking, driving, keyboard or lifting tolerance, Oswestry, pain scales, etc): Objective measures of the patient’s functional performance in the clinic (e.g., able to lift 10 lbs floor to waist x 5 repetitions) are preferred, but this may include self-report of functional tolerance and can document the patient self-assessment of functional status through the use of questionnaires, pain scales, etc (Oswestry, DASH, VAS, etc.)

Physical Impairments (e.g., joint ROM, muscle flexibility, strength, or endurance deficits): Include objective measures of clinical exam findings. ROM should be in documented in degrees.

Approach to Self-Care and Education Reduced Reliance on Other Treatments, Modalities, or Medications: This includes the provider’s assessment of the patient compliance with a home program and motivation. The provider should also indicate a progression of care with increased active interventions (vs. passive interventions) and reduction in frequency of treatment over course of care. (California, 2007)

For chronic pain, also consider return to normal quality of life, e.g., go to work/volunteer each day; normal daily activities each day; have a social life outside of work; take an active part in family life. (Cowan, 2008)



Functional MRI

Not recommended. May be appropriate in a research setting. Functional neuroimaging is helping to identify the sensory and emotional components of pain and its autonomic responses, and may help in the design of more rational treatments for pain. However, this test is only useful in a research setting at this time and does not have a role in the evaluation or treatment of patients. There are no studies about the use of functional MRI in a clinical setting. (Borsook2, 2000) In this study functional magnetic resonance imaging (fMRI) combined with support vector machine (SVM) algorithms accurately predicted thermal pain 81% of the time in healthy subjects. (Brown, 2011) The algorithms are based on mind reading technology that has been used in cognitive neuroscience, but the technology is not yet ready for clinical application. Researchers are investigating whether this is an objective biomarker for chronic pain that could not only eventually help monitor pain therapies but also distinguish patients with real chronic pain. (Ung, 2012)

Functional restoration programs (FRPs)

Recommended for selected patients with chronic disabling pain, although research is still ongoing as to how to most appropriately screen for inclusion in these programs. Functional restoration programs (FRPs), a type of treatment included in the category of interdisciplinary pain programs (see Chronic pain programs), were originally developed by Mayer and Gatchel. FRPs were designed to use a medically directed, interdisciplinary pain management approach geared specifically to patients with chronic disabling occupational musculoskeletal disorders. These programs emphasize the importance of function over the elimination of pain. FRPs incorporate components of exercise progression with disability management and psychosocial intervention. Long-term evidence suggests that the benefit of these programs diminishes over time, but still remains positive when compared to cohorts that did not receive an intensive program. (Bendix, 1998) There appears to be little scientific evidence for the effectiveness of multidisciplinary biopsychosocial rehabilitation compared with other rehabilitation facilities for neck and shoulder pain, as opposed to low back pain and generalized pain syndromes. (Karjalainen, 2003) Treatment is not suggested for longer than 2 weeks without evidence of demonstrated efficacy as documented by subjective and objective gains. For general information see Chronic pain programs. See also DWC MTUS chapter on Low Back Complaints .

GABAdone™

Not recommended. GABAdone™ is a medical food that is a proprietary blend of Choline Bitartrate, Glutamic Acid, 5-Hydroxytryptophan, and GABA. See Medical foods.

Gabapentin (Neurontin®)

Recommended for some neuropathic pain conditions and fibromyalgia. (Wiffen-Cochrane, 2013) Gabapentin is an anti-epilepsy drug (AEDs - also referred to as anti-convulsants), which has been shown to be effective for treatment of diabetic painful neuropathy and postherpetic neuralgia and has been considered as a first-line treatment for neuropathic pain. See Anti-epilepsy drugs (AEDs) for general guidelines, as well as specific Gabapentin listing for more information and references.

Galvanic stimulation

Not recommended. Considered investigational for all indications. Galvanic stimulation is characterized by high voltage, pulsed stimulation and is used primarily for local edema reduction through muscle pumping and polarity effect. Edema is comprised of negatively charged plasma proteins, which leak into the interstitial space. The theory of galvanic stimulation is that by placing a negative electrode over the edematous site and a positive electrode at a distant site, the monophasic high voltage stimulus applies an electrical potential which disperses the negatively charged proteins away from the edematous site, thereby helping to reduce edema. (BlueCrossBlueShield, 2005)

Genetic testing for potential opioid abuse

While there appears to be a strong genetic component to addictive behavior, current research is experimental in terms of testing for this. Studies are inconsistent, with inadequate statistics and large phenotype range. Different studies use different criteria for definition of controls. More work is needed to verify the role of variants suggested to be associated with addiction and for clearer understanding of their role in different populations. (Levran, 2012) Translating pharmacogenetics to clinical practice has been particularly challenging in the context of pain, due to the complexity of this multifaceted phenotype and the overall subjective nature of pain perception and response to analgesia. Overall, numerous genes involved with the pharmacokinetics and dynamics of opioids response are candidate genes in the context of opioid analgesia. Overall, the level of evidence linking genetic variability to opioid response is strong; however, there has been no randomized clinical trial on the benefits of genetic testing prior to oxycodone therapy. On the other hand, predicting the analgesic response to morphine based on pharmacogenetic testing is more complex; though there was hope that simple genetic testing would allow tailoring morphine doses to provide optimal analgesia, this is unlikely to occur. A variety of polymorphisms clearly influence pain perception and behavior in response to pain. However, the response to analgesics also differs depending on the pain modality and the potential for repeated noxious stimuli, the opioid prescribed, and even its route of administration. (Vuilleumier, 2012) See also Cytokine DNA testing.

Glucosamine (and Chondroitin sulfate)

Recommended as an option (glucosamine sulfate only) given its low risk, in patients with moderate arthritis pain, especially for knee osteoarthritis. Studies have demonstrated a highly significant efficacy for crystalline glucosamine sulphate (GS) on all outcomes, including joint space narrowing, pain, mobility, safety, and response to treatment, but similar studies are lacking for glucosamine hydrochloride (GH). For all herbals and dietary supplements, there may be concerns for potential interactions with prescription and over-the-counter medications and lack of manufacturing quality controls. (Richy, 2003) (Ruane, 2002) (Towheed-Cochrane, 2001) (Braham, 2003) (Reginster, 2007) (Reginster, 2001) (Pavelka, 2002) (Clegg, 2006) (Reichenbach, 2007) The Glucosamine Chondroitin Arthritis Intervention Trial (GAIT) funded by the National Institutes of Health concluded that glucosamine hydrochloride (GH) and chondroitin sulfate were not effective in reducing knee pain in the study group overall, but the GAIT investigators did not use glucosamine sulfate (GS). (Distler, 2006) Despite multiple controlled clinical trials of glucosamine in osteoarthritis (mainly of the knee), controversy on efficacy related to symptomatic improvement continues. Differences in results originate from the differences in products, study design and study populations. Symptomatic efficacy described in multiple studies performed with glucosamine sulphate (GS) support continued consideration in the OA therapeutic armamentarium. Compelling evidence exists that GS may reduce the progression of knee osteoarthritis. Results obtained with GS may not be extrapolated to other salts (hydrochloride) or formulations (OTC or food supplements) in which no warranty exists about content, pharmacokinetics and pharmacodynamics of the tablets. (Reginster, 2007) [Note: DONA™ Glucosamine Sulfate is the original crystalline glucosamine sulfate (GS), which was first developed and marketed for human use by Rotta Research Laboratorium, funding some of the initial trials. Glucosamine hydrochloride (GH) is not proprietary, so it tends to be less expensive but there has also been less funding for quality studies.] See also the DWC MTUS chapter on knees, since many studies involved arthritis of the knee.

Recent research: The benefit of glucosamine with or without chondroitin remains unclear. (Sawitzke, 2008) However, the possible interaction between chondroitin and anticoagulants may be an issue for some patients. (Rozenfeld, 2004) Glucosamine and/or chondroitin may not be helpful for patients with osteoarthritis of the hip or knee, according to the results of a recent meta-analysis in BMJ, but the authors concluded that neither of the preparations are dangerous, and there is no harm in having patients continue these preparations as long as they perceive a benefit and cover the costs of treatment themselves. (Wandel, 2010)

Green tea

Not recommended for chronic pain. There is insufficient literature to support the use of green tea for chronic pain.

Haveos™ genetics opioid abuse testing

The Haveos genetics opioid abuse test is offered by Salugen® Biosciences, Inc., a Los Angeles biotechnology company that develops and markets proprietary laboratory tests to personalize pain medicine therapies. See Genetic testing for potential opioid abuse.

Herbal medicines

Not recommended for chronic pain. There is insufficient literature to support the use of herbal medicines for chronic pain.

Home health services

These services include both medical and non-medical services for patients who are homebound and who require one or a combination of the following: (1) Skilled nursing care by a licensed medical professional for tasks such as administration of intravenous drugs, dressing changes, physical therapy, speech-language pathology services, and occupational therapy; (2) Home health aide services for health-related tasks and assistance with activities of daily living that do not require skills of a medical professional, such as bowel and bladder care, feeding, bathing, dressing and transfer and assistance with administration of oral medications; and/or (3) Domestic services such as shopping, cleaning, laundry that the individual is no longer capable of performing due to the illness or injury. These services do not require specialized training and do not need to be performed by a medical professional.

Home health care services are medically necessary where the medical condition results in an inability to leave the home for medical treatment and/or an inability to perform specific custodial or homemaker services. (ACMQ, 2005) (Ellenbecker, 2008) Justification for medical necessity requires documentation of:

(1) The medical condition that necessitates home health services, including objective deficits in function and the specific activities precluded by such deficits;

(2) The expected kinds of services that will be required, with an estimate of the duration and frequency of such services; and

(3) The level of expertise and/or professional licensure required to provide the services.

Evaluation of the medical necessity of Home Health Care services must be made on a case-by-case basis. The physician’s treatment plan usually includes an in-home evaluation by a Home Health Care Agency Registered Nurse to assess the appropriate scope, extent, and level of care for home health care services. A one-time home health care evaluation is appropriate if the treatment plan is unclear and not already ordered by the treating physician.



Homeopathic topicals

Not recommended for the treatment of chronic pain.

Honey & cinnamon

Not recommended for the treatment of chronic pain. There is insufficient literature to support the use of honey and cinnamon for chronic pain.

Horizontal therapy (HT)

See Interferential current stimulation (ICS).

Hospital length of stay (LOS)

Recommend the median length of stay (LOS) based on type of surgery, or best practice target LOS for cases with no complications. For prospective management of cases, median is a better choice that mean (or average) because it represents the mid-point, at which half of the cases are less, and half are more. For retrospective benchmarking of a series of cases, mean may be a better choice because of the effect of outliers on the average length of stay. Length of stay is the number of nights the patient remained in the hospital for that stay, and a patient admitted and discharged on the same day would have a length of stay of zero. The total number of days is typically measured in multiples of a 24-hour day that a patient occupies a hospital bed, so a 23-hour admission would have a length of stay of zero. (HCUP, 2011) See also DWC MTUS chapters on specific body parts.
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