Chronic pain: What colour are the emperor s clothes? Saifee Rashiq MB MSC DA(UK) FRCPC

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REFRESHER COURSE OUTLINE R1 Chronic pain: What colour are the emperor s clothes? Saifee Rashiq MB MSC DA(UK) FRCPC MOST publicly-funded chronic pain clinics are overwhelmed with demands for service. The sheer number of patients suffering from this complex and still largely ill-understood group of conditions dictates that specialists working in referral centres will, at best, only ever be able to see and treat a small proportion of selected cases in a timely fashion. This, in turn, suggests that there would be great benefit to placing accurate and unbiased information about effective first-line treatment for chronic pain in the hands of the family physician or other referring doctor. This would enable treatment to begin much earlier and might even reduce the numbers of patients referred. Unfortunately, the extant literature in this area is vast and of highly variable quality. Few primary care practitioners or pain management specialists are able to devote the necessary time to obtaining and reading all ostensibly relevant material, much less to analyzing its methodology and rating its quality. Health Technology Assessment (HTA) is a relatively new discipline in which specialists in research methodology distil the medical research literature into credible information that policy makers and clinicians can use. The combined efforts of practicing clinicians and HTA specialists can therefore lead to the production of information from the literature that is simultaneously relevant and methodologically robust. The Ambassador Program is a unique program from Alberta that uses this approach to present the latest research evidence on the treatment of chronic pain to front-line health professionals In this session, we will review selected portions of this evidence in an interactive format. A much more detailed version of the information presented below is to be found at (www.ahfmr.ab.ca/hta/ambassador/). Acupunture Q: Is acupuncture effective in the management of non-specific, non-malignant low back pain? In patients with low back pain, evidence indicates that acupuncture: Is not more effective than conventional treatments. These results are based on poor quality randomized controlled studies. What is the effectiveness of acupuncture based on the number of needles, number and duration of sessions and the duration of the intervention period? What is the incidence of adverse events associated with acupuncture? There is no evidence to support the use of acupuncture for low back van Tulder MW, Cherkin DC, Berman B, Lao L, Koes BW. Acupuncture for low back In: The Cochrane Library, (Oxford). (Date of the most substantive amendment: February 1999) 2004; 1: CD001351. Antidepressants Q: Are antidepressants effective in the management of non-malignant low back pain? Antidepressants that inhibit norepinephrine reuptake (tricycles and tetracyclics) are moderately effective in reducing Selective serotonin reuptake inhibitors do not appear to be beneficial for patients with low back Due to the fact that acute back pain usually resolves in one to three months, it seems that antidepressants should not be used routinely for acute back From the Department of Anesthesiology and Pain Medicine, Walter Mackenzie Health Sciences Centre, University of Alberta, Edmonton, Alberta, Canada. Address correspondence to: Dr. Saifee Rashiq, Department of Anesthesiology and Pain Medicine, Walter Mackenzie Health Sciences Centre, 8440-112 Street, University of Alberta, Edmonton, Alberta T6G 2B7, Canada. Phone: 780-407-8896; Fax: 780-4-7-3200; E-mail: srashiq@ualberta.ca CAN J ANESTH 2005 / 52: 6 / pp R1 R7

R2 CANADIAN JOURNAL OF ANESTHESIA What is the mechanism of action of tricyclic and tetracyclic antidepressants on back pain? Whether tricyclic medications impact functional status of the patients with low back What are the benefits and risks of antidepressants in the treatment of patients with (chronic) low back pain? Old-fashioned tricyclic antidepressants are an effective treatment for chronic back pain, at much lower doses than might be used for depression. Staiger TO, Gaster B, Sullivan MD, Deyo RA. Systematic review of antidepressants in the treatment of chronic low back Spine 2003; 28: 2540 5. Behavioural therapy Q: Is behavioural therapy effective in the management of chronic non-malignant low back pain $ three months duration? What type of behavioural therapy is the most effective? that behavioural therapy: is more effective than no treatment; offers no advantage when combined with other treatments. The various types of behavioural therapy (cognitive, operant, respondent, cognitive-behavioural) do not differ in their effectiveness. Is behavioural therapy more effective than other conservative treatments? Which of the various behavioural therapies is the most effective, and for which patient subgroups? Although behavioural therapy may be effective, a more multidisciplinary approach is recommended. Among the various forms of behavioural treatment, cognitive-behavioural (CBT) has the broadest appeal. Refer to a psychologist or other provider who has specific training and experience with this approach. CBT for chronic pain management is not part of the skill set of generalist mental health providers. van Tulder MW, Ostelo RWJ, Vlaeyen JWS, et al. Behavioural treatment for chronic low back 2000. In: The Cochrane Library. Chichester, UK: John Wiley & Sons, Ltd; 2004(2). Cannabinoids Q: Is the use of cannabis or cannabinoids effective for the treatment of non-malignant pain $ three months duration? Cannabis-based medicinal extracts: are more effective than placebo in the short term (two to 13 weeks); provide significant pain relief; do not improve spasticity symptoms in multiple sclerosis. What is not known The efficacy of cannabis (smoked, ingested or imbibed) is unknown (no research found). Optimum treatment regimen (route of administration, dosage, type and source of active compound (synthetic or natural). How cannabis-based medicinal extracts interact with other medications. Whether effectiveness fluctuates with increasing pain severity or length of treatment. s. Refractory neuropathic pain may warrant treatment with oral cannabinoids. The medical prescription of smoked marijuana is medico-legally precarious as there is no available evidence. There are several randomized controlled trials currently underway in Canada and the USA comparing smoked marijuana to placebo that should provide further insight into the value of smoked marijuana in the management of chronic Harstall C. Use of cannabis or cannabinoids for nonmalignant chronic Alberta Heritage Foundation for Medical Research TechNote 42, Available from URL: http://www.ahfmr.ab.ca/publications.html. February 2004. Epidural steroid injections Q: Are epidural steroid injections effective in the management of non-malignant low back pain and/or sciatica?

R3 There is inconclusive evidence on the effectiveness of epidural steroid injections for the treatment of low back pain and/or sciatica. The benefits of epidural steroid injections, if any, seem to be of short duration only. Transient complaints are reported after epidural steroid injections such as: headache, nausea, pruritis, increased pain of sciatic distribution, puncture of the dura. Which patients are most likely to benefit from epidural steroid injections? What is the efficacy of epidural steroid injections on patients with persistent sciatica? What is the risk for serious complications? What is the average number of epidural steroid injections needed for the treatment of low back pain and sciatica? What are the long term effects of epidural steroid injections (beyond six months)? Epidural steroid injections are effective in acute sciatica, but are likely not useful in chronic back pain without leg Koes BW, Scholten RJ, Mens JM, Bouter LM. Epidural steroid injections for low back pain and sciatica: an updated systematic review of randomized clinical trials. Pain Digest 1999; 9: 241 7. Exercise therapy Q: Is exercise therapy effective in the management of chronic non-malignant low back pain $ three months duration? What type of exercise is the most effective? that exercise therapy is: more effective than usual care by general practitioners; as effective as conventional physiotherapy (hot packs, massage, traction, mobilization, shortwave diathermy, ultrasound, stretching, flexibility and coordination exercises, electrotherapy); useful for facilitating return to normal daily activity and work. Strengthening exercises are not more effective than mild exercises, conventional physical therapy exercises, or stretching exercises. Specific back exercises have no clinical effect and are not recommended for chronic low back pain patients. Is exercise therapy more effective than inactive or placebo treatment? What type of exercise, flexion or extension, is more effective? Are strengthening exercises more effective than inactive treatment? It is almost never wrong to encourage exercise in chronic low back The exercise program should be re-assessed by a knowledgeable practitioner if the exercises exacerbate the van Tulder MW, Malmivaara A, Esmail R, Koes BW. Exercise therapy for low back 2000. In: The Cochrane Library. Chichester, UK: John Wiley & Sons, Ltd; 2004(2). Gabapentin Q: Is gabapentin(gbp) effective in the management of non-malignant chronic pain $ three months duration? For the treatment of diabetic neuropathy and postherpetic neuralgia: is more effective than placebo; provides significant pain relief with minimal adverse effects; improves measures of sleep, mood, quality of life, and subject and clinician-based assessments of change; is safe and well tolerated. What is not known The efficacy of GBP for other neuropathic pain conditions The most efficacious dose of GBP; studies reported titrations of between 300 mg and 3600 mg per day. The long-term efficacy (beyond three months), safety and tolerability of GBP. Whether the therapeutic effects, tolerability and safety of GBP are better than those of older generation anticonvulsants or antidepressants. Gabapentin is an appropriate first line drug for neuropathic

R4 The effective daily dose varies widely (100 mg to 6,000 mg) and is impossible to predict from patient to patient. Adverse effects can be decreased and tolerability increased by initiating gabapentin at a very low dose and increasing very gradually. Corabian P. Gabapentin for non-malignant chronic Alberta Heritage Foundation for Medical Research TechNote 47. Available from URL: http://www.ahfmr.ab.ca/publications.html, July 2004. Long-acting opioids Q: Are long-acting opioids (oral or transdermal) safe and effective in the management of chronic nonmalignant pain $ three months duration? In patients with chronic non-malignant pain, evidence indicates that long-acting oxycodone and short-acting oxycodone are equally effective for pain control. Is one long-acting opioid more safe and effective than another? Is one long-acting opioid more safe and effective than another in particular patient subgroups? Are long-acting opioids more safe and effective than short-acting opioids? What is the minimum dose of long-acting opioids required to achieve a clinically significant treatment effect? In constant severe chronic pain, long-acting opioids are the medication dosing strategy of choice. Patients frequently prefer long-acting opioids due to once or twice a day dosing schedules. Careful attention to incremental changes in pain intensity, function and side effects are required to achieve optimal benefit. A history of addiction is a relative contraindication. Consultation with an addictions specialist may be helpful in these cases. Chou R, Clark E, Helfand M. Comparative efficacy and safety of long-acting oral opioids for chronic non-cancer pain: a systematic review. J Pain Symptom Manage 2003; 26: 1026 48. CANADIAN JOURNAL OF ANESTHESIA Massage therapy Q: Is massage therapy effective in the management of chronic non-malignant low back pain $ three months duration? What type of massage is the most effective? that massage therapy: is more effective than relaxation therapy; is less effective than transcutaneous electrical nerve stimulation; has durable effects that last for up to one year. Acupuncture massage may be superior to classical (Swedish) massage. The most significant benefits are obtained by either licensed massage therapists or massage therapists with many years experience Is massage therapy more effective than inactive, placebo, or no treatment? Is massage therapy more effective than other active treatments (e.g. spinal manipulation, acupuncture, exercise)? What is the optimum number and duration of treatment sessions? Which of the various massage techniques is the most effective, and for which patient subgroups? A trial of massage therapy, if affordable to the patient, may be a useful adjunct to an overall treatment program. It does not substitute for interventions which address key causative or perpetuating factors in their chronic low back Well trained and experienced massage practitioners are likely to generate the best results. Furlan AD, Brosseau L, Imamura M, Irvin E. Massage for low back 2002. In: The Cochrane Library. Chichester, UK: John Wiley & Sons, Ltd; 2004(2). Multidisciplinary pain programs Q: Are multidisciplinary pain programs (MPPs) effective and efficient in the management of patients with chronic non-malignant pain = 3 months duration? that in well established programs: MPP with a functional restoration approach produces greater improvements in pain and function than non-multidisciplinary rehabilitation or

R5 usual care; Less intensive MPP are not effective. It is not appropriate to refer patients with chronic low back pain for a multidisciplinary intervention without knowing the actual content of the program. In patients with chronic pelvic back pain, evidence indicates that in well established programs: MBPSR improves function but does not reduce In patients with fibromyalgia, widespread musculoskeletal pain, and neck and shoulder pain the evidence is inconclusive. Whether the observed outcomes are attributable to a particular treatment modality or to the interactions among multiple treatments; Optimal duration and intensity for specific conditions and level of involvement of the patients and their families; Which category (condition, symptoms and level of pain severity) of patients benefit the most from MPPs; Cost effectiveness of MPPs remains unknown. Get to know the MPP in your referral centre and use it for selected cases of CLBP and pelvic MPP should be considered for patients who are significantly affected by chronic pain who have failed to improve with adequate trials of first line treatment Ospina M, Harstall C. Multidiscipline pain programs for chronic pain: evidence from systematic reviews. Alberta Heritage Foundation for Medical Research, HTA 30. Available from URL: http://www.ahfmr.ab.ca/publications.html, January 2003. Muscle relaxants Q: Are muscle relaxants effective in the management of chronic non-malignant low back pain = 3 months duration? Tetrazepam is effective on short-term chronic low back pain relief Muscle relaxants must be used with caution due to possible side effects associated with the central nervous system (e.g. drowsiness, dizziness) There is a controversy in the recommendations found in national clinical guidelines for the management of low back pain in primary care. Some guidelines recommend muscle relaxants alone or in combination with NSAIDs as optional, others clearly do not recommend using muscle relaxants. Are muscle relaxants more effective than other treatments: drugs (analgesics or NSAIDs) or interventions in reducing pain? Are peripherally acting muscle relaxants (drugs which do not act through the central nervous system) effective for the treatment of low back pain? Some muscle relaxants may be appropriate in selected patients for symptomatic relief of low back pain and muscle spasm. Caution must be exercised with managing side effects, particularly drowsiness and with patient selection given the abuse potential for this class of drugs. van Tulder MW, Touray T, Furlan AD, Solway S, Bouter LM. Muscle relaxants for non-specific low back pain," The Cochrane Library, (Oxford). 2004; 1: CD004252. Nonsteroidal anti-inflammatory drugs (NSAIDS) Q: Are non-steroidal anti-inflammatory drugs effective in the management of non-malignant low back pain? In patients with low back pain: There is inconclusive evidence on the effectiveness of NSAIDs when compared to other therapies (drugs and interventions) There is no difference in effectiveness between different NSAIDs. Mild to moderately severe side effects were frequently reported including: abdominal pain, diarrhea, edema, dry mouth, rash, dizziness, headache, tiredness, etc. Whether NSAIDs are more effective than other (drug) therapies, including simple analgesics. What are the long term effects (risks of gastrointestinal and other side effects) of NSAIDs? AIs there a clear difference in the reported number and severity of side effects between different types of NSAIDs?

R6 CANADIAN JOURNAL OF ANESTHESIA NSAIDs work, but are not a benign treatment. There doesn t seem to be much evidence in choosing between them. Koes BW, Scholten RJ, Mens JM, Bouter LM. Efficacy of non-steroidal anti-inflammatory drugs for low back pain: a systematic review of randomized clinical trials. Ann Rheum Dis 1997; 56: 214 23. Prolotherapy Q: Are prolotherapy injections safe and effective in the management of chronic non-malignant low back pain $ 3 months duration? that prolotherapy injections: are not effective as a sole treatment; may be effective when used in conjunction with either manipulation or exercises. Prolotherapy injections are not associated with serious or permanent adverse events. However, they may result in a transient increase in pain and stiffness. Repeated ligament injections, irrespective of solution, may give prolonged improvement in pain and disability when administered as part of multimodal treatment. Are prolotherapy injections more effective than non-injection therapies or no treatment? Are prolotherapy injections more effective in particular patient subgroups? Is there a dose response to prolotherapy injection, and if so, what is the minimum dose/intensity required to achieve a clinically significant treatment effect? Does the needling action, the injection solution, or both, contribute to the treatment effect? Which of the various co-interventions commonly used in prolotherapy (e.g. superficial skin injection of local anesthetic, vitamin/mineral supplements) is the most effective? Prolotherapy is most appropriate and effective in carefully selected and monitored patients who are participating in an appropriate program of exercise and/or manipulation/mobilization. Yelland MJ, Del Mar C, Pirozzo S, Schoene ML, Vercoe P. Prolotherapy injections for chronic low-back In: The Cochrane Library. Chichester, UK: John Wiley & Sons, Ltd; 2004(2). Spinal manipulative therapy Q: Is spinal manipulative therapy safe and effective in the management of chronic non-malignant low back pain = 3 months duration? that spinal manipulative therapy: is no more effective at reducing pain than sham treatment; is no more effective at improving disability scores than NSAIDs. Is spinal manipulative therapy more effective than NSAIDs in reducing pain? Is spinal manipulative therapy more effective than short wave diathermy, acupuncture, back school, physiotherapy, or no treatment? Is spinal manipulative therapy safe? The evidence does not support Spinal Manipulative Therapy as a treatment for chronic low back Acute low back pain was not the focus of this systematic review and as such does not address the efficacy of this treatment approach for acute low back Ferreira ML, Ferreira PH, Latimer J, Herbert R, Maher C. Does spinal manipulative therapy help people with chronic low back pain? Australian Journal of Physiotherapy 2002; 48: 277 84. Transcutaneous electrical nerve stimulation (TENS) Q: Is TENS safe and effective in the management of chronic non-malignant low back pain $ three months duration? that TENS: does not reduce pain, improve functional status, or increase range of motion and activity; is not effective as a sole treatment. These conclusions are the same regardless of whether high or low frequency TENS is used.

R7 What is the optimal frequency and intensity for TENS application? How is the effectiveness of TENS influenced by site of application and treatment duration? Is TENS effective when combined with other treatments such as vibratory stimulation? TENS may be useful in select patients for pain control in order to avoid or reduce the need for medications. A short trial (two to three treatments) using different stimulation parameters should be sufficient to determine if the patient will respond to this modality. Does the needling action, the injection solution, or both, contribute to the treatment effect? How strong is the placebo effect in TPI therapy? A short trial (three sessions of TPI) is worth trying in focal chronic pain of the neck, head and shoulders in a patient who can be relied upon to do stretching exercises. Scott A, Guo B. Trigger point injections for non-malignant chronic Edmonton, AB: Alberta Heritage Foundation for Medical Research (HTA 34). Available from URL: http://www.ahfmr.ab.ca/publications. html, August 2004. Milne S, Welch V, Brosseau L, et al. Transcutaneous electrical nerve stimulation (TENS) for chronic low back 2000. In: The Cochrane Library. Chichester, UK: John Wiley & Sons, Ltd; 2004(2). Trigger point injections (TPI) Are TPI safe and effective in the management of chronic non-malignant pain $ 3 months duration? Evidence indicates that TPI: plus intra-articular injection of sodium hyaluronate may be safe and effective for treating knee pain caused by osteoarthritis; when performed as a sole treatment, may be effective in relieving the symptoms of chronic head, neck, and shoulder pain, whiplash syndrome, and cervicogenic headache; simple injectants such as saline and sterile water are safer than botox and are equally effective; with lidocaine in combination with neck stretching exercises is as effective as combined ultra sound therapy/neck stretching, both of which are more effective than neck stretching alone for treating chronic head, neck, and shoulder Is there a dose response to TPI, and if so, what is the minimum dose/intensity required to achieve a clinically significant treatment effect? Does the type or volume of fluid injected affect treatment outcomes? Is there a difference in treatment effect between specific wet needling of the trigger point and non-specific injection of fluid into the region surrounding the trigger point?