Active exercise, education, and cognitive behavioral therapy for persistent disabling low back pain: a randomized controlled trial. Opioid substitution to improve the effectiveness of chronic noncancer pain control: a chart review. Chronic disease self-management program for low back pain in the elderly. Counseling plus buprenorphine-naloxone maintenance therapy for opioid dependence.
A randomized controlled trial.
                To determine 1) whether, among patients with persistent disabling low back pain (LBP), a group program of exercise and education using a cognitive behavioral therapy (CBT) approach, reduces pain and disability over a subsequent 12-month period; 2) the cost-effectiveness of the intervention; and 3) whether a priori preference for type of treatment influences outcome.
                There is evidence that both exercise and CBT delivered in specialist settings is effective in improving LBP. There is a lack of evidence on whether such interventions, delivered by trained individuals in primary care, result in improved outcomes.
                The study was conducted in nine family medical practices in East Cheshire, UK. Patients 18 to 65 years of age, consulting with LBP, were recruited; those still reporting LBP 3 months after the initial consultation were randomized between the two trial arms. The intervention arm received a program of eight 2-hour group exercise session over 6 weeks comprising active exercise and education delivered by physiotherapists using a CBT approach. Both arms received an educational booklet and audio-cassette. The primary outcome measures were pain (0-100 Visual Analogue Scale) and disability (Roland and Morris Disability Scale; score 0-24).
                A total of 196 subjects (84%) completed follow-up 12 months after the completion of the intervention program. The intervention showed only a small and nonsignificant effect at reducing pain (-3.6 mm; 95% confidence interval, -8.5, 1.2 mm) and disability (-0.6 score; 95% confidence interval, -1.6, 0.4). The cost of the intervention was low with an incremental cost-effectiveness ratio of pound5000 (U.S. $8650) per quality adjusted life year. In addition, patients allocated to the intervention that had expressed a preference for it had clinically important reductions in pain and disability.
                This intervention program produces only modest effects in reducing LBP and disability over a 1-year period. The observation that patient preference for treatment influences outcome warrants further investigation. We evaluated the efficacy and tolerability of opioids in the long-term management of chronic noncancer pain. This retrospective chart review included 86 outpatients who started receiving, between 1994 and 1998, long-acting opioids. For each patient, the number of different opioids used and the efficacy and tolerability of each opioid prescribed were noted. During a mean follow-up of 8.8 +/- 6.3 mo, the number of opioids used by each patient was 2.3 +/- 1.4. Patient diagnoses were: back pain (31), neuropathy (20), joint pain (13), visceral pain (7), reflex sympathetic dystrophy (7), headache (5), fibromyalgia (3). The first opioid prescribed was effective for 36% of patients, was stopped because of side effects in 30%, and was stopped for ineffectiveness in 34%. Of the remaining patients, the second opioid prescribed after the failure of the first was effective in 31%, the third in 40%, the fourth in 56%, and the fifth in 14%. There was one case of addiction and no case of tolerance. We conclude that if it is necessary to change the opioid prescription because of intolerable side effects or ineffectiveness, the cumulative percentage of efficacy increases with each new opioid tested. Failure of one opioid cannot predict the patient's response to another. Implications: This study showed that if a patient receiving chronic opioid therapy experiences an intolerable side effect or if the drug is ineffective, changing to a different opioid may result in a lessening or elimination of the side effect and/or improved analgesia. To evaluate the effectiveness of Stanford's Chronic Disease Self-Management Program (CDSMP) for chronic low back pain (LBP) in older Americans.
                Randomized controlled trial.
                Community-based program offered at 12 locations.
                Community-dwelling seniors (n = 109) aged 60 and older with chronic LBP of mechanical origin.
                Patients were randomly allocated to the CDSMP or to a 6-month, wait-list control group. The program included one 2.5-hour session per week for 6 weeks. Outcomes evaluated at 6 months included 100-point modified Von Korff pain and disability scales; days with pain and disability; SF-36 general health, energy-fatigue, and emotional well-being scales; 2 scales from the Arthritis Self-Efficacy Scale, self-care attitudes/behaviors, and health services utilization.
                For pain at 6 months, the primary outcome, the adjusted mean difference between the program and control, was -1.0 (P = .835). There was a sizable advantage for the program in disability averaged over the course of the entire 6-month study (-9.2, P = .027), but not at the 6-month follow-up (-5.8, P = .278). There was an interaction between intervention and baseline disability days favoring the program for higher baseline values (P = .007). The CDSMP affected emotional well-being (7.6, P = .037) and energy-fatigue (5.1, P = .274). There were no differences for self-efficacy, pain days, and general health.
                There was no advantage for the CDSMP over a wait-list control for improving pain, general health, self-efficacy, and self-care attitudes in older Americans with chronic LBP. A benefit was suggested for emotional well-being, fatigue, functional disability, and days with disability. The optimal level of counseling and frequency of attendance for medication distribution has not been established for the primary care, office-based buprenorphine-naloxone treatment of opioid dependence.
                We conducted a 24-week randomized, controlled clinical trial with 166 patients assigned to one of three treatments: standard medical management and either once-weekly or thrice-weekly medication dispensing or enhanced medical management and thrice-weekly medication dispensing. Standard medical management was brief, manual-guided, medically focused counseling; enhanced management was similar, but each session was extended. The primary outcomes were the self-reported frequency of illicit opioid use, the percentage of opioid-negative urine specimens, and the maximum number of consecutive weeks of abstinence from illicit opioids.
                The three treatments had similar efficacies with respect to the mean percentage of opioid-negative urine specimens (standard medical management and once-weekly medication dispensing, 44 percent; standard medical management and thrice-weekly medication dispensing, 40 percent; and enhanced medical management and thrice-weekly medication dispensing, 40 percent; P=0.82) and the maximum number of consecutive weeks during which patients were abstinent from illicit opioids. All three treatments were associated with significant reductions from baseline in the frequency of illicit opioid use, but there were no significant differences among the treatments. The proportion of patients remaining in the study at 24 weeks did not differ significantly among the patients receiving standard medical management and once-weekly medication dispensing (48 percent) or thrice-weekly medication dispensing (43 percent) or enhanced medical management and thrice-weekly medication dispensing (39 percent) (P=0.64). Adherence to buprenorphine-naloxone treatment varied; increased adherence was associated with improved treatment outcomes.
                Among patients receiving buprenorphine-naloxone in primary care for opioid dependence, the efficacy of brief weekly counseling and once-weekly medication dispensing did not differ significantly from that of extended weekly counseling and thrice-weekly dispensing. Strategies to improve buprenorphine-naloxone adherence are needed. (ClinicalTrials.gov number, NCT00023283 [ClinicalTrials.gov].).
                Copyright 2006 Massachusetts Medical Society.
Despite concerns surrounding the use of opioids for long-term management of chronic LBP, there remain few high-quality trials assessing their efficacy. The trials in this review, although achieving high internal validity scores, were characterized by a lack of generalizability, inadequate description of study populations, poor intention-to treat analyses, and limited interpretation of functional improvement. Based on our results, the benefits of opioids in clinical practice for the long-term management of chronic LBP remain questionable. Therefore, further high-quality studies that more closely simulate clinical practice are needed to assess the usefulness, and potential risks, of opioids for individuals with chronic LBP.