 September-October 2008; Issue 17
This edition of News/Research Updates was researched/compiled by Winnie Dawson, MA, RN, BSN [WD], and edited by Stewart B. Leavitt, MA, PhD [SBL]. Medical reviewers were: James D. Toombs, MD; Lee A. Kral, PharmD, BCPS; Seth I. Kaufman, MD; Edward Hesterlee, PharmD, FACA. Posting Date: October 20, 2008.
 Development of these Pain Treatment Topics News/Research Updates was supported by an unrestricted educational grant from COVIDIEN/Mallinckrodt, St. Louis, MO. Any mention of product brand names is for informational purposes only and such brands are registered trademarks of their respective manufacturers. In some cases, additional product brands may be available.
 Access to all external URL links was checked prior to posting; however, some may change or become obsolete over time and will no longer function. This is beyond our control.
10 Million Americans Use Opioid Analgesics
Epidemiologists at Boston University in Massachusetts evaluated the prevalence of adult opioid analgesic use in the United States using data obtained from a random-dial telephone household survey. Questions about opioid use overall, the characteristics of opioid use, and the use of all medications taken during the preceding week were posed to 19,150 participants aged 18 years and older during interviews from 1998 to 2006. “Regular” opioid use was defined as 5 or more days per week for a month or longer. Some key findings include:
- Opioids were used regularly by 2% of adults surveyed, and used “less frequently” by an additional 3%.
- Regular opioid use decreased with educational level but increased with age.
- The greatest use was in the South Central region of the United States.
- Almost half of regular users had been taking opioids for 2 or more years and nearly 20% had been taking opioids for 5 years or longer.
- Pain was the number one reason people reported taking opioids — 20% reported back pain, 26% reported headache or other cause, and 13% had arthritis.
- Regular opioid users reported higher non-opioid medication use than nonusers (including other analgesics, laxatives, proton pump inhibitors, antidepressants, and other prescription drugs). Almost 1 in 5 opioid users reported concomitant use of 10 or more additional drugs.
- Use of medications for chronic conditions, such as ACE inhibitors for cardiovascular disease and insulin for diabetes, was higher in regular opioid users than in nonusers.
Clinical Concepts: The researchers estimate opioid analgesics are used by more than 10 million American adults and that approximately 4.3 million are regular users, taking opioids at least 5 days per week for a minimum of 4 weeks. According to the authors, the results of this survey were comparable to 2 European studies, but these data reflected lower opioid use in comparison to several prior studies of U.S. population subsets. Because this survey population included only households with landlines (not cell phones), a higher proportion of women respondents, and a higher level of education, a population bias is possible. The potential for opioid-use underreporting is generally lower with the use of anonymous surveys such as this; however, the possibility of underreporting cannot be eliminated.
Reference: Parsells Kelly J, Cook SF, Kaufman DW, et al. Prevalence and characteristics of opioid use in the US adult population. Pain. 2008(Sep 15);138(3):507-513.
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Evidence Review: Opioid Analgesic Abuse & Addiction Uncommon in Patients with Chronic Pain
Investigators from the Miller School of Medicine at the University of Miami, Florida, conducted a structured evidence-based review of all available studies as of 2006 to assess the development of abuse/addiction and aberrant drug-related behaviors in patients with chronic noncancer pain exposed to long-term opioid analgesic therapy. They identified 67 reports of good quality for their analyses, making it the most comprehensive review to date.
For the abuse/addiction analysis there were 24 studies encompassing 2507 patients in whom the abuse/addiction rate was 3.27%. However, among those patients in this analysis specifically with de novo abuse/addiction (without a previous or current history of substance-use problems) the rate was only 0.19%.
In an analysis of aberrant drug-related behaviors (ADRB) there were 17 studies encompassing 2466 patients and the ADRB rate was 11.5%. Within this grouping, among those preselected as not having a prior or current history of abuse/addiction, the rate of ADRBs was only 0.59%.
There were 5 studies encompassing 15,442 patients with chronic noncancer pain exposed to long-term opioid therapy that assessed urine toxicology as a surrogate indicator of abuse/addiction or ADRBs. Here, 20.4% of the patients had no prescribed opioid in their urine and/or a non-prescribed opioid in urine. In another 5 studies (1965 patients total) illicit drugs were reported in 14.5% of patients, although distinctions were not made between patients with or without prior substance-use problems.
Clinical Implications: Based on their comprehensive review, the authors suggest that clinicians can be relatively certain that long-term opioid exposure will lead to abuse/addiction in a relatively low percentage of patients with chronic pain. Furthermore, the chance of iatrogenic abuse/addiction development is rare in those patient without a prior history of substance-use disorders. Aberrant drug-related behaviors are a more sizable problem, and clinicians need to watch for signs of such behaviors and employ urine toxicology testing as appropriate.
[Editorial Comment: In the above study, Fishbain et al. concede that this sort of research can be confounded by unclear or inconsistent definitions of opioid “addiction,” “abuse,” and “aberrant behaviors” used across studies. In fact, due to imprecisions of definition they had to combine abuse and addiction in their overall analyses; however, they suggest that the 3.27% incidence of abuse/addiction could have been lower if standardized and accurate criteria had been used. Furthermore, they note that many studies did not report any abuse or addiction. If is assumed that this represents zero incidence, rather than an oversight by the authors, and these studies are combined with the others the already low rate of abuse/addiction without prior history of such problems might have been merely 0.07%.
A review by Fleming et al. in 2007 – published after the cut-off date for inclusion in the Fishbain et al. investigation – examined the rate of substance-use disorders in a population of patients receiving daily opioid therapy for chronic noncancer pain prescribed by primary-care physicians. Their analysis of 801 adult patients found that 3.7% met DSM-IV clinical criteria for an opioid-use disorder, either abuse (0.6%) or dependence/addiction (3.1%).
This 3.7% rate, using validated criteria from the “Diagnostic and Statistical Manual of Mental Disorders” (DSM) for defining abuse and addiction, is strikingly close to the 3.27% rate of abuse/addiction reported by Fishbain et al. This might suggest that previous studies inadvertently used definitions of abuse and addiction that have some validity. However, the study by Fleming and colleagues did not distinguish between those patients with or without a prior history of substance abuse problems.
There is still some question as to how rates of opioid abuse/addiction in patients with chronic pain compare with the general population. Fishbain et al. (2008) noted that the prevalence of addiction in the general population is approximately 10%. Whereas, Fleming and colleagues (2007) claimed the frequency specifically of opioid use disorders in the general population is merely 0.9%. However, neither group of authors provided reference sources for these data, and the veracity of the 0.9% figure in particular is questionable, so conclusions in this regard would be tenuous at best.
As for illicit drug use in chronic pain patients, the rates are disturbingly high but the numbers are inflated by a high prevalence specifically of marijuana use. Whether or not patients are using this agent for potential medicinal effects or strictly non-medical (recreational) purposes is not considered in the research and probably should be examined as a problem distinct from the use of either non-prescribed opioids or illicit drugs such as cocaine or heroin. – SBL]
References:
Fishbain DA, Cole B, Lewis J, Rosomoff HL, Rosomoff RS. What percentage of chronic nonmalignant pain patients exposed to chronic opioid analgesic therapy develop abuse/addiction and/or aberrant drug-related behaviors? A structured evidence-based review. Pain Med. 2008;9(4):444-459.
Fleming MF, Balousek SL, Klessig CL, et al. Substance use disorders in a primary care sample receiving daily opioid therapy. The Journal of Pain. 2007;8(7):573-582.
 See News/Research Update: “Abuse of Opioid Analgesics in Primary Care Studied.”
Available at: http://pain-topics.org/news_research_updates/issue10.php#abuse
 For further commentary on this subject, see “Iatrogenic Opioid-Use Problems; What’s the Risk” in the Pain-Topics.org e-Briefing newsletter (Vol. 2, No. 1, 2007).
Available at: http://www.pain-topics.org/pdf/e-Briefing-Vol2-No1-2007.pdf
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SR Morphine, Methadone, Fentanyl Effectiveness Compared
Researchers in Italy compared the analgesic and adverse effects, doses, and cost factors of 3 analgesia therapies. Cancer patients (n=70) no longer responsive to opioids for moderate pain, completed a study in which they were randomly switched to either initial daily doses 60 mg of oral sustained-release (SR) morphine, or 15 mg of oral methadone, or 0.6 mg (25 mcg/hr) of transdermal fentanyl. During titration of each opioid, oral morphine was used as breakthrough pain medication. Opioid doses, pain intensity, and adverse effects were recorded at weekly intervals for 4 weeks. Costs of opioid therapy, use of supportive drugs, and other analgesic drugs were also evaluated.
No differences in pain and symptom intensity were observed across the 3 opioid medications. Total opioid escalation was significantly lower in patients receiving methadone (p < 0.0001), although they did require up and down changes in doses. At the doses used, methadone was significantly less expensive (p < 0.0001), while the use and costs of supportive drugs and other analgesics were similar in the 3 groups. No relevant differences in adverse effects were observed among the groups during either the titration phase or ongoing treatment.
Practice Pointers: All 3 opioids – SR morphine, methadone, fentanyl – used as first-line therapy for substitution (opioid rotation) were effective, well tolerated, and required similar amounts of supportive drugs or co-analgesics. Methadone was significantly less expensive, but required more adjustments of dosing, suggesting that dose titration of this drug requires special clinical attention.
Source: Mercadante S, Porzio G, Ferrera P, et al. Sustained-release oral morphine versus transdermal fentanyl and oral methadone in cancer pain management. Eur J Pain. 2008;12(8):1040-1046.
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Rizatriptan Helps Relieve Menstrual Migraine
Two migraine subtypes were defined by the International Headache Society in 2004: A) pure menstrual migraine (PMM) designating headache attacks only during menstruation, and B) menstrually-related migraine (MRM) with episodes occurring at other times during the cycle. A study published in the September 2008 issue of the journal Headache reported on the efficacy of rizatriptan (Maxalt®) in these two difficult-to-treat migraine subtypes.
Two identical randomized, double-blind studies were conducted in 707 adult women (146 with PMM, 561 with MRM) who were instructed to take either a single 10 mg tablet of rizatriptan or placebo to treat an acute attack of moderate to severe pain intensity.
For the PMM group, pain relief at 2 hours (primary outcome) was 73% for rizatriptan versus 50% for placebo (p = 0.006). The MRM group showed similar results with treated and placebo groups reporting pain relief of 71% and 52% (p < 0.001), respectively. While no serious adverse events were reported in the treatment groups, there were reports of somnolence (5%), palpitations (3%), dizziness (3%), fatigue (2%), and joint stiffness (2%) when compared with placebo (0% for all 5 effects).
Practice Pointers: Rizatriptan also showed a numerically greater response for 24-hour sustained pain relief and other efficacy measures that were not tested statistically. The authors concluded that rizatriptan appears to offer a treatment option for acute migraine attacks in these 2 subgroups of patients with menstrual migraine. [However, it could be of interest that at least half of placebo-group subjects in these studies reported pain relief. – SBL]
Reference: Nett R, Mannix LK, Mueller L, et al. Rizatriptan efficacy in ICHD-II pure menstrual migraine and menstrually related migraine. Headache. 2008(Sep);48(8):1194-1201.
 Caution: Rizatriptan is indicated for the treatment of acute migraine attacks and is not intended for migraine prophylaxis. Because rizatriptan may increase blood pressure or cause coronary vasospasm, it should not be used in patients with uncontrolled hypertension or in patients who have symptoms of ischemic heart disease or coronary artery vasospasm. Patients who are taking MAO inhibitors should not take rizatriptan concurrently or within 2 weeks following the discontinuation of MAO inhibitor therapy. – WD
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Three Questions Help Identify Carpal Tunnel Syndrome
Carpal tunnel syndrome (CTS) – a disorder involving median nerve irritation within the carpal tunnel of the wrist – can be difficult to diagnose because other conditions can mimic CTS symptoms. Researchers developed a simple questionnaire as an aid to screening patient with CTS-like symptoms such as pain, tingling, and numbness in the hand. A 7-item survey was completed by 100 consecutive patients before being referred for electrodiagnostic testing.
Following electrodiagnostic nerve conduction studies, the results were compared to questionnaire responses and 3 key questions were identified as useful in predicting a diagnosis of CTS:
- Tingling in at least 2 of the first 4 digits,
- Symptoms that worsen at night or upon awakening, and
- Improvement on shaking the hand.
Two or more positive responses to the 3 questions predicted an abnormal electrodiagnostic test in 97% of cases (p < 0.001).
Practice Implications: The authors concluded that this 3-question survey can result in more timely referrals to specialists due to its high sensitivity for predicting electrodiagnostic abnormalities that are typical of CTS.
Reference: Rigler I, Podnar S. A three item questionnaire to screen for carpal tunnel syndrome. American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) 55th Annual Meeting. Providence, RI. September 17-20, 2008. Meeting Abstract:134.
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Shock Wave Therapy Safe, Effective for Plantar Fasciitis
Conservative treatment for plantar fasciitis could include short-term rest, ice, orthotic devices, stretching exercises, and anti-inflammatory medications. However, the symptoms of pain and inflammation do not resolve quickly and cortisone injections or surgery may be recommended for patients with chronic plantar fasciitis.
Physicians in Germany designed a randomized, controlled trial to compare the efficacy of 3 treatments of radial extracorporeal shock wave therapy (rESWT) with placebo in 245 patients with chronic plantar fasciitis. Primary outcomes were changes in visual analog scale (VAS) composite pain scores from baseline to follow-up at 12 weeks, overall success rates, and individual VAS scores for 3 different types of foot pressure.
At 12 weeks, the VAS score was reduced almost 72% in rESWT-treated patients versus 45% in placebo patients (p = 0.022), and demonstrated an overall success rate of 61% compared with 42% in the placebo group (p = 0.002). The researchers reported that results were even greater at 12 months and all secondary outcome measures supported rESWT as significantly superior to placebo (p < 0.025) without significant side effects.
Clinical Concepts: This study demonstrated efficacy for recalcitrant plantar fasciitis and, as a noninvasive office-based procedure, may be a safe alternative to surgery. Minor adverse effects – including swelling, minor petechial bleeding, and discomfort – can occur during treatment.
[Comment: A related commentary in Podiatry Today by Lowell Weil, Jr, DPM, reported that most insurance companies do not currently reimburse patients for extracorporeal shockwave therapy. Healthcare providers should alert patients of this and suggest that they contact their insurance providers when cost is a concern – WD]
Reference: Gerdesmeyer L, Frey C, Vester J, et al. Radial extracorporeal shock wave therapy is safe and effective in the treatment of chronic recalcitrant plantar fasciitis: results of a confirmatory randomized placebo-controlled multicenter study. Am J Sports Med. 2008(Oct 1); [Early online publication prior to print].
 Also see…
The Pain-Topics.org FAQ: “Is shockwave therapy a valid alternative for treating plantar fasciitis?”
Available at: http://pain-topics.org/faqs/index1.php#plantar
Prior News/Research Updates item: “Shockwave Therapy for Plantar Fascitis.”
Available at: http://pain-topics.org/news_research_updates/index2.php#shockwave
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Arthroscopic Knee Surgery Doesn’t Enhance Osteoarthritis Outcomes
Knee osteoarthritis is a common cause of disability and pain in aging adults. A Canadian study published in the New England Journal of Medicine reports results of a randomized, controlled trial in patients with moderate-to-severe osteoarthritis of the knee. Patients (n=178) were randomly assigned to arthroscopic surgery plus optimized physical and medical therapy or to physical and medical therapy alone. Outcome measures included symptom and quality of life assessment scores at a 2-year follow-up point.
Both groups reported similar improvements in joint pain, stiffness, and function at the 2-year endpoint. The interim and endpoint Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores failed to show statistically significant differences between the two groups; quality of life outcomes also failed to support the benefits of arthroscopy in this population.
Clinical Concepts: In a related news story (WebMD Health News), Robert Litchfield, MD, noted that while arthroscopic knee surgery was not more beneficial than optimized physical and medical therapy alone for people suffering from osteoarthritis, “it is still a beneficial procedure for many other conditions such as meniscal and ligament problems” in the knee.
Reference: Kirkley A, Birmingham TB, Litchfield RB, et al. A randomized trial of arthroscopic surgery for osteoarthritis of the knee. NEJM. 2008(Sep 11);359(11):1097-1107.
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Glucosamine, Chondroitin Fail to Halt OA Progression
The pain and inflammation that is characteristic of knee osteoarthritis (OA) is caused by structural damage. The joint space between the femur and tibia narrows until the synovial membrane and cartilage wear away and, ultimately, results in contact of the 2 bone surfaces. Researchers from the University of Utah School of Medicine evaluated the effect of glucosamine and chondroitin sulfate (CS), alone or in combination, compared with celecoxib or placebo on the progression of joint space width (JSW) loss in patients with knee osteoarthritis. This was part of the Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT) in which 9 research centers participated in a 24-month, double-blind study enrolling a total of 572 patients who met radiographic criteria for knee OA.
The minimum medial tibiofemoral JSW in patients who had been randomized to 1 of 5 study groups was measured at baseline, 12 months, and 24 months. Each patient group followed their assigned protocol for 24 months and the 5 treatment groups included:
> Glucosamine 500 mg – 3 x daily,
> Chondroitin sulfate 400 mg – 3 x daily,
> Glucosamine 500 mg plus chondroitin sulfate 400 mg – 3 x daily,
> Celecoxib 200 mg total per day, and
> Placebo.
The results were evaluated according to the mean change in JSW from baseline (primary outcome measure). At 2 years, results showed no statistically significant difference in the mean loss of JSW in any treatment group when compared with the placebo group. The researchers did note a trend toward improvement in all treatment groups compared with the placebo group in knees classified as moderately affected.
Clinical Implications: The researchers stated their concern that the trial was probably not long enough or large enough, but suggested that the improvement trend identified in patients with moderate knee OA may provide new insights for future research. In a related news story (Medical News Today), Daniel Clegg, MD, stated that the research provided new insights on “how osteoarthritis progresses” and “techniques that can measure joint space width loss more reliably.”
Reference: Sawitzke AD, Shi H, Finco MF, et al. The effect of glucosamine and/or chondroitin sulfate on the progression of knee osteoarthritis: a report from the glucosamine/chondroitin arthritis intervention trial. Arthritis Rheum. 2008(Sep 29);58(10):3183-3191.
[Editor’s Comment: Unfortunately, this present study is not informative regarding pain relief afforded by glucosamine and/or chondroitin. Despite the limitations of clinical research investigations to date, the preponderance of evidence and consensus opinions suggest that glucosamine and chondroitin can be used safely but these agents are unlikely to provide any significant benefit for most patients whose joints have already suffered damage from osteoarthritis. Supplements are just one potential component of a comprehensive, individualized treatment plan for osteoarthritis, which may also include exercise and physical therapy, weight loss, medication, and possibly surgery in the most recalcitrant cases. – SBL]
Also see other Pain-Topics.org items on this subject…
“Arthritis Foundation Statement on Chondroitin and Pain Relief”
Available at: http://pain-topics.org/guidelines_reports/PositionPolicyConsensus.php#musculoskeletal
“Glucosamine Unhelpful for Hip Osteoarthritis” [News/Research Update]
Available at: http://pain-topics.org/news_research_updates/issue14.php#Glucosamine
“Chondroitin Ineffective for Osteoarthritis Pain” [News/Research Update]
Available at: http://pain-topics.org/news_research_updates/issue8.php
“Supplements for Joint Pain Challenged” [News/Research Update]
Available at: http://pain-topics.org/news_research_updates/premiere.php#joint
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Review: Duloxetine for Fibromyalgia and Diabetic Neuropathy
Duloxetine (Cymbalta®) – a serotonin and norepinephrine reuptake inhibitor (SNRI) – has been FDA-approved for the treatment of both fibromyalgia and diabetic neuropathy. A systematic review of randomized, controlled trials of duloxetine identified 3 trials in painful diabetic neuropathy (PDN) and 3 studies that evaluated the drug to treat symptoms of fibromyalgia.
Results demonstrated consistent efficacy of duloxetine for the treatment of PDN and fibromyalgia. Significantly more patients experienced at least 50% improved pain relief from baseline during 12-week therapy with duloxetine 20 mg, 60 mg, or 120 mg daily compared with placebo. The combined data for all doses treating patients with both conditions (n= 2216) showed that the number needed to treat (NNT) for one patient to realize at least a 50% pain reduction with duloxetine compared with placebo was 5.9.
Overall, duloxetine was well tolerated, with an incidence of withdrawal from the studies only slightly higher than patients in the placebo group. While most adverse effects were mild or moderate (nausea, somnolence, constipation, dry mouth), duloxetine doses higher than 60 mg did not provide additional pain relief but caused slightly more study withdrawals due to side effects.
Clinical Concepts: The investigators reported that these sizeable, randomized, double-blind trials were of good methodological quality. Two limitations included a lack of long-term studies and the inclusion of a small number of fibromyalgia patients with depression. The authors concluded that duloxetine appears to be equally effective and “likely to be a useful drug” for the treatment of PDN and fibromyalgia.
Sources: Sultan A, Gaskell H, Derry S, et al. Duloxetine for painful diabetic neuropathy and fibromyalgia pain: systematic review of randomised trials. BMC Neurol. 2008(Aug);8:29.
Duloxetine prescribing information can be downloaded at: http://pi.lilly.com/us/cymbalta-pi.pdf (access checked 10/7/08).
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Study Shows Pain is Common in Parkinson’s Disease
A report from researchers in Italy provides insight into the prevalence of pain in patients with Parkinson’s disease (PD) – an age-related, chronic, progressive movement disorder. A survey of 402 patients with PD were matched in age with 317 healthy subjects. Probability models were used to compare types of pain, time intervals between pain and PD onset, and potential confounders.
The fact that patients with PD demonstrated a significantly higher frequency of pain than controls (70% vs. 63%, respectively; p = 0.04) was attributed to the lack of dystonic pain in the healthy controls. (Dystonic pain is caused by central nervous system dysfunction, which can result in spasmodic abnormal movements, contractures, or postural abnormalities). The frequency of non-dystonic pain – such as musculoskeletal, rheumatic, neuritic, or radicular pain – was similar in the 2 groups (p = 0.28). Cramping and central neurological pain was more frequent in patients with PD, and non-dystonic pain demonstrated a significant association with PD just after the onset of parkinsonian symptoms.
Clinical Implications: The authors concluded that the findings “suggest that pain among Parkinson’s disease patients is heterogeneous in quality, body localization, and relationship with the clinical onset of Parkinson’s disease.” They further suggested that studies to further understand the nature of pain in Parkinson’s disease would help to “identify specific treatment strategies” in this population.
Reference: Defazio G, Berardelli A, Fabbrini G, et al. Pain as a nonmotor symptom of Parkinson disease: evidence from a case-control study. Arch Neurol. 2008(Sep);65(9):1191-1194.
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Alexander Technique Fosters Long-Term Back-Pain Relief
Chronic back pain is a common clinical challenge and many patients are interested in nonpharmacological pain-relief therapies. Investigators in the United Kingdom recruited 152 therapists who agreed to provide either massage therapy or lessons in the Alexander Technique (a discipline that teaches the individual to focus on the self-perception of movement and develop more physical control to maximize body function). Patients with a history of chronic or recurrent low back pain (n=579) from 64 general practices were randomized to one of 8 therapy groups:
> Massage – 6 sessions
> Alexander Technique – 6 lessons
> Alexander Technique – 24 lessons
> Normal care (control)
> Four additional groups were created by adding prescribed aerobic exercise and structured behavioral counseling to the regimen of half of the patients from each group.
Primary outcome measures were changes in disability scores and the number of painful days in the most recent 4 weeks. Secondary measures included quality of life, pain and disability, overall improvement, and fear avoidance beliefs for physical activity. Patient questionnaires were completed at baseline, 3 months, and one year.
All interventions reported significant improvement at 3 months, while the groups who performed exercise and took lessons in the Alexander Technique reported significant improvement at both 3 months and one year. Overall, quality of life and the average number of days with back pain improved significantly with Alexander Technique lessons compared with controls and those in the massage therapy group. The effect of only 6 Alexander Technique lessons-plus-exercise on disability scores and most other outcomes achieved 72% of the beneficial effect experienced by those in the 24-lesson group (with no exercise) at study’s end.
Practice Pointers: Because the 6 Alexander Technique lessons retained benefits at one year when compared with massage therapy, the authors state “the long-term benefit of the lessons is unlikely to result from non-specific placebo effects of attention and touch.” When learned and practiced regularly, it appears that use of the Alexander Technique may replace poor posture habits with changes in positioning that potentially reduce back pain by decreasing muscle spasm, strengthening postural muscles, improving flexibility, and reducing spinal compression.
[Comment: The design of this study seems overly complex, although Alexander Technique lessons demonstrated clear benefits. Health risks while using the Alexander Technique are minimal because it is a subtle practice of posture control and breathing, but interested patients with chronic back pain should discuss the technique with their healthcare providers in advance. A licensed teacher of the Alexander Technique can be found through the American Society for the Alexander Technique at http://www.alexandertech.org. – WD, SBL]
Reference: Little P, Lewith G, Webley F, et al. Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain. British Medical Journal. 2008(Aug 23);337:a884.
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Survey Shows Inadequate Pain Relief For Cancer Patients
Researchers at the University of Pennsylvania Hospital in Philadelphia designed an Internet-based questionnaire to survey cancer patients regarding the causes of their pain and the reasons for not achieving adequate pain relief. An invitation to participate in the questionnaire was posted on the OncoLink website (a resource service of the Abramson Cancer Center at the university) from November 2005 to April 2006.
Responses from 106 patients who received radiation oncology treatment provided the following data:
- 58% reported treatment-related pain and 46% stated that their pain was directly from their cancer [this assumes patients can distinguish one type of pain from the other, and the percentage of patients having both types of pain was not reported – SBL].
- Overall, 51% with pain said it was chronic and a third reported intermittent pain.
- 80% of those with pain did not use medication to manage their pain; many used alternative therapies.
- Reasons for not using analgesic drugs included:
-- the radiation oncologist did not mention medication – 87%,
-- fear of addiction or dependence – 79%, and
-- inability to pay for medications – 79%.
Clinical Implications: While 243 respondents participated in the survey, only the 106 people who received radiotherapy were evaluated in this study report. Due to the fact that participants were computer-users and primarily Caucasian women with an education beyond high school, these respondents were not representative of the national population overall. However, the authors suggest that the high percentage of patients who did not use analgesic drugs to manage their pain is an indication that healthcare providers should talk with all cancer patients about their pain symptoms and pain medications.
[Comment: The fact that 8 of 10 indicated that drug cost was a deterrent to using medications for achieving pain relief should be of some concern. – SBL]
Reference: Simone CB 2nd, Vapiwala N, Hampshire MK, et al. Internet-based survey evaluating use of pain medications and attitudes of radiation oncology patients toward pain intervention. Int J Radiat Oncol Biol Phys. 2008(Sep);72(1):127-133.
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Massage Therapy Benefits Mood & Cancer-Pain Relief
Massage therapy is frequently viewed by patients and professionals alike as a comforting nonpharmacologic pain reliever, but only a few studies have actually suggested its efficacy for pain relief. Researchers from the University of Colorado in Denver designed a multi-site clinical trial to evaluate the benefits of massage for pain relief and improved quality of life in patients with advanced cancer. Adult patients with moderate-to-severe cancer pain (n=298 analyzed) were randomized to 2 weeks of either massage therapy or a control group receiving simple touch (touch therapists used light, consistent hand pressure for 3 minutes at 10 specific anatomical locations). Patients in the massage group received six 30-minute massage sessions by a licensed massage therapist using a variety of techniques.
The primary outcome measures were the immediate and sustained change in pain scores (0-10 point scale). Secondary outcomes were immediate heart and respiratory rates plus measures of mood change; additional long-term outcomes of symptom distress, analgesic use, and change in quality of life were evaluated.
Results of the immediate evaluation showed that both groups achieved improvements, but massage therapy significantly reduced pain and improved mood to a greater degree (p < 0.001). However, longer-term assessments of pain scores and secondary outcome measures failed to show significant statistical or clinical differences between groups.
Practice Pointers: While the results failed to show sustained symptom relief, the immediate effects of massage may offer considerable short-term value to patients whose quality of life is dramatically compromised by daily pain and emotional distress. The authors noted their awareness of common concerns about the safety of massage in cancer patients, but they reported that there were no statistically significant differences in adverse events or deaths in this population. Ninety percent of study participants were enrolled in hospice programs.
[Comment: Patients with advanced cancer pain and symptoms should get physician approval before beginning massage therapy with a licensed therapist experienced in this patient population. Additionally, it could be advisable to suggest that patients inquire about massage therapy insurance benefits before beginning this treatment. – WD]
Reference: Kutner JS, Smith MC, Corbin L, et al. Massage therapy versus simple touch to improve pain and mood in patients with advanced cancer. Ann Intern Med. 2008(Sep 16);149(6):369-79.
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Spinal Cord Stimulation Adds Cost But Improves Outcomes in Treating Neuropathic Pain
Chronic back and leg pain conditions result in patients’ loss of function, reduced quality of life, and increased costs to society. This multinational study assessed health-related quality of life (HRQoL) and cost implications of spinal cord stimulation plus non-surgical conventional medical management (SCS group) versus non-surgical conventional medical management alone (CMM group) in the management of neuropathic pain in patients with failed back surgery syndrome.
A total 100 patients were randomized to either the SCS or CMM group. The 6-month mean total healthcare cost in the SCS group was significantly higher than in the CMM group (p < 0.001). However, the gain in HRQoL with SCS over the same period of time was markedly greater in the SCS group at 6 months (p < 0.001).
Clinical Implication: The authors conclude that the addition of spinal cord stimulation to conventional medical management in patients with neuropathic leg and back pain results in higher costs to health systems but also generates important improvements in patients’ quality of life over the same period.
Reference: Manca A, Kumar K, Taylor RS, et al. Quality of life, resource consumption and costs of spinal cord stimulation versus conventional medical management in neuropathic pain patients with failed back surgery syndrome (PROCESS trial). Eur J Pain. 2008;12(8):1047-1058.
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Chiropractic Therapy Not Advantageous for Acute Back Pain
Many patients seek chiropractic intervention for alleviating back pain. However, spinal manipulation therapy (SMT) may not always be advantageous in reducing acute low back pain, according to a study from Switzerland published in the Annals of the Rheumatic Diseases.
Researchers studied 104 patients with acute low back pain to determine whether treatment with SMT plus standard care was associated with greater reductions in pain or medication usage, as compared with standard care alone. “Standard care” consisted of medical advice along with anti-inflammatory drugs or analgesics as needed (only paracetamol, diclofenac or dihydrocodeine were allowed). Study participants were randomly assigned to one of the 2 treatment groups.
The researchers found that differences in pain reduction between the 2 groups were not statistically significant. Although the group treated with SMT seemed to use less pain medication initially, the differences in medication usage were not statistically significant and decreased over time.
Clinical Concepts: Current American guidelines for the treatment of low back pain often recommend early referral to a chiropractor for SMT in order to reduce the likelihood of developing persistent or chronic low back pain. However, these guidelines are not universal, and this study suggests that SMT may not necessarily reduce either the intensity of acute back pain or the need for pain medications.
Reference: Juni P, Battaglia M, Nuesch E, et al. A randomised controlled trial of spinal manipulative therapy in acute low back pain. Ann Rheum Dis. 2008 [September 5, published online prior to print.]
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PIDS – A Newly-Named Chronic Pain Symptom Cluster
A recent evidence-review article in the Journal of Pain & Palliative Care Pharmacotherapy proposes that pain, insomnia, and depression might be considered together as a commonplace symptom cluster in persons with chronic nonmalignant pain. As such, it should be called the Pain Insomnia Depression Syndrome, or PIDS. Naming this symptom complex as PIDS could increase awareness of the chronic pain comorbidities of insomnia and depression and result in more effective symptom management and improved clinical outcomes.
Studies suggest that chronic pain is a risk factor for insomnia; and, conversely, insomnia has been shown to reduce the pain threshold and increase pain intensity. Other research shows insomnia to be a risk factor for developing depression and, at the same time, insomnia is considered a symptom of depression and part of its diagnostic criteria in the DSM-IV. Researchers also have found chronic pain to be a risk factor for developing depression, and depression has been associated with poor pain outcomes. Therefore, all of these symptoms are interrelated in a somewhat circular fashion.
Clinicians should routinely assess patients with nonmalignant chronic pain for comorbid insomnia and depression as possible risk factors. Taking PIDS into consideration will result in more effective symptom management, better pain management, and improved health outcomes. However, practitioners also need to consider that treatment for one symptom may either improve or exacerbate other symptoms.
Reference: Collen M. The Case for Pain Insomnia Depression Syndrome (PIDS): A Symptom Cluster in Chronic Nonmalignant Pain. J Pain Pall Care Pharmacother. 2008;22(3):221-225.
[Comment: Author Mark Collen is himself a person with chronic pain and a member of the Editorial Board of the Journal of Pain & Palliative Care Pharmacotherapy. He also created and coordinates an on-line exhibit of artistic expressions of pain, PainExhibit.com, which is featured in the Pain-Topics.org Pain-Art Gallery. See: http://pain-topics.org/gallery.php. – SBL]
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New Website “Talks Pain,” Addresses Doctor-Patient Disconnects
“Let’s Talk Pain” is a new, industry-sponsored website developed by a coalition of organizations, including the American Pain Foundation (APF), American Academy of Pain Management (AAPM), and the American Society for Pain Management Nursing. The goal of this website is to encourage people affected by pain and their healthcare professionals to talk more about pain, to listen actively, and to act in ways that improve care for people who live with pain.
The APF and AAPM are Pain Treatment Topics affiliate organizations.
A nationwide survey in the United States commissioned by the Let's Talk Pain Coalition uncovered the need for improved communication between patients and physicians. The survey was conducted with 500 chronic pain patients and 275 physicians who treat pain, including primary care physicians, oncologists, pain specialists, neurologists, rheumatologists, surgeons, and psychiatrists. Survey results point to serious disconnects between patients and their physicians, for example:
- Approximately 60% of patients strongly agreed that they can be open and honest about their pain with their physicians; however, fewer than 10% of physicians believed that their patients tell them the truth about their pain.
- Nearly all (97%) of the physicians felt that there was enough time to discuss pain with their patients, yet less than half (46%) of patients felt the same way.
- While many physicians (75%) stated that sexual relations and social activities were least important in selecting their patients’ pain treatments, nearly half of the patients (48%) complained that pain either strongly or completely interferes with their sex lives.
Reference: See the website at http://www.letstalkpain.org. Access checked 10/11/08.
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Recent Drug or Device Approvals and Announcements
Following are briefs on new pain-management drug or device approvals or announcements, as well as items related to safety concerns for existing products. If the FDA or DEA news websites posted a specific announcement, the link to it has been provided below. All brand names are registered trademarks of their respective manufacturers.
Additionally, the FDA Center for Drug Evaluation and Research website offers the option to search on any approved drug name or active ingredient at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm, and safety information is posted by FDA’s MedWatch at http://www.fda.gov/medwatch/safety/2006/safety06.htm.
Valproic Acid Delayed-Release (Stavzor™) – Approved for Migraine Prophylaxis
Banner Pharmacaps announced a July 2008 FDA approval of Stavzor – a delayed-release softgel capsule formulation of valproic acid – for seizures, bipolar manic disorder, and migraine prevention. Valproic acid, an anticonvulsant, is believed to affect the neurotransmitter GABA, which partially regulates neuronal excitability throughout the nervous system but the exact mechanism is unknown. For migraine therapy, approval was based on a trial of several dosing protocols in 2 randomized, double-blind studies in 283 patients with a 6-month history of migraine. Recommendations for migraine prevention suggest a starting dose of 250 mg twice daily, although some patients may require doses up to 1000 mg/day. Adverse effects can include somnolence, dizziness, and gastrointestinal problems like nausea, vomiting, dyspepsia, diarrhea, and increased appetite.
Prescribing information can be downloaded at:
http://www.stavzor.com/pdfs/Stavzor-full-prescribing-information.pdf (access checked October 9, 2008).
To read the FDA announcement, see:
http://www.centerwatch.com/patient/drugs/dru995.html (access checked October 9, 2008).
Rituximab (Rituxan®) – Genentech Issues New Package Insert
Genentech, Inc., informed healthcare professionals that Rituxan prescribing information has been updated to include a fatal adverse event — a case of progressive multifocal leukoencephalopathy (PML) that lead to the death of a patient with rheumatoid arthritis who received Rituxan in a long-term safety clinical study. The drug has previously been associated with PML in patients with hematologic malignancies and off-label use in autoimmune diseases. The manufacturer warns clinicians to be alert for new-onset neurological symptoms in any patient being treated with rituximab.
The manufacturer’s letter to healthcare professionals can be downloaded at:
http://www.fda.gov/medwAtch/safety/2008/rituxan_DHCP_Final%209411700.pdf (access checked October 6, 2008).
Difluprednate Ophthalmic Emulsion (Durezol™)0.05% – Available for Ocular Surgical Pain
The FDA granted approval in June 2008 of Durezol, the first topical ophthalmic corticosteroid indicated for the treatment of inflammation and pain associated with ocular surgery. The approval was based on efficacy demonstrated in 2 multicenter, randomized, double-blind, placebo-controlled, parallel-group studies of 245 ocular surgery patients. Sirion Therapeutics, Inc., the manufacturer, announced that Durezol will be commercially available as of October 2008.
Prescribing information can be downloaded at:
http://www.fda.gov/cder/foi/label/2008/022212lbl.pdf (access checked October 7, 2008).
For further information, see the Sirion press release at:
http://www.prnewswire.com/mnr/durezol/34934/ (access checked October 7, 2008).
Nebion HLX-8 Magnetic Resonance Device – FDA Class 1 Recall
Healthcare professionals received notification during October 2008 of an FDA Class 1 Recall (the most serious type of product recall due to the potential for serious injury or death) of the Nebion HLX-8 Magnetic Resonance Device. The product is not FDA-approved, lacks safety and efficacy data, and was not produced using good manufacturing practices. Additionally, the FDA stated that the manufacturer was making unsupported claims that the HLX-8 could be used to treat cancer, carpal tunnel syndrome, migraine headaches, premenstrual symptoms, rheumatoid arthritis, and other diseases and conditions. The Nebion HLX-8 was distributed from June 1, 2007 through June 11, 2008 by Nebion, LLC without FDA approval.
For further recall information, see: http://www.fda.gov/cdrh/recalls/recall-062508.html (access checked October 3, 2008).
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