Exercise treatment effect modifiers in persistent low back pain: an individual participant data meta-analysis of 3514 participants from 27 randomised controlled trials.

BACKGROUND: Low back pain is one of the leading causes of disability worldwide. Exercise therapy is widely recommended to treat persistent non-specific low back pain. While evidence suggests exercise is, on average, moderately effective, there remains uncertainty about which individuals might benefit the most from exercise. METHODS: In parallel with a Cochrane review update, we requested individual participant data (IPD) from high-quality randomised clinical trials of adults with our two primary outcomes of interest, pain and functional limitations, and calculated global recovery. We compiled a master data set including baseline participant characteristics, exercise and comparison characteristics, and outcomes at short-term, moderate-term and long-term follow-up. We conducted descriptive analyses and one-stage IPD meta-analysis using multilevel mixed-effects regression of the overall treatment effect and prespecified potential treatment effect modifiers. RESULTS: We received IPD for 27 trials (3514 participants). For studies included in this analysis, compared with no treatment/usual care, exercise therapy on average reduced pain (mean effect/100 (95% CI) -10.7 (-14.1 to -7.4)), a result compatible with a clinically important 20% smallest worthwhile effect. Exercise therapy reduced functional limitations with a clinically important 23% improvement (mean effect/100 (95% CI) -10.2 (-13.2 to -7.3)) at short-term follow-up. Not having heavy physical demands at work and medication use for low back pain were potential treatment effect modifiers-these were associated with superior exercise outcomes relative to non-exercise comparisons. Lower body mass index was also associated with better outcomes in exercise compared with no treatment/usual care. This study was limited by inconsistent availability and measurement of participant characteristics. CONCLUSIONS: This study provides potentially useful information to help treat patients and design future studies of exercise interventions that are better matched to specific subgroups. PROTOCOL PUBLICATION: https://doi.org/10.1186/2046-4053-1-64.

Effectiveness and drug adherence of biologic monotherapy in routine care of patients with rheumatoid arthritis: a cohort study of patients registered in the Danish biologics registry.

OBJECTIVES: To estimate the prevalence of Danish RA patients currently on biologic monotherapy and compare the effectiveness and drug adherence of biologic therapies applied as monotherapy. METHODS: All RA patients registered in the Danish biologics database (DANBIO) as receiving biologic DMARD (bDMARD) treatment as monotherapy without concomitant conventional synthetic DMARDs (csDMARDs) during the study period 1 May, 2011 through 30 April 2013 were eligible for inclusion. All patient files were checked to ensure that they were in accordance with the treatment registration in DANBIO. Descriptive statistics for prevalence, effectiveness and drug adherence of bDMARD monotherapy were calculated. RESULTS: Of the 775 patients on bDMARD monotherapy, adalimumab (21.3%), etanercept (36.6%) and tocilizumab (15.3%) were the most prevalent biologic agents administered. At the 6-month follow-up, the overall crude clinical disease activity index remission rate in patients still on a biologic drug was 22%, the 28-joint DAS remission rate was 41% and the response rate of those with a 50% improvement in ACR criteria was 28%. At the 6-month follow-up, the drug adherence rates were similar for the different bDMARDs, with the exception of infliximab, which had significantly poorer drug adherence (P < 0.001). The overall drug adherence (except for infliximab) was approximately 70% after 2 years. CONCLUSION: Nearly one in five (19%) biologic treatments for RA was prescribed in Denmark as monotherapy, of which 70% were on monotherapy from bio-initiation and 30% were on monotherapy after cessation of a concomitant csDMARD. Acceptable drug adherence and remission rates were achieved with bDMARDs. With the exception of infliximab, no statistically significant differences were observed between anti-TNFs and biologics with other modes of action.

Treatment of chronic low back pain: a randomized, clinical trial comparing group-based multidisciplinary biopsychosocial rehabilitation and intensive individual therapist-assisted back muscle strengthening exercises.

STUDY DESIGN: A stratified randomized single-blinded clinical trial. OBJECTIVE: To compare the efficacies of 2 active therapies for chronic low back pain (CLBP). SUMMARY OF BACKGROUND DATA: Both a multidisciplinary biopsychosocial rehabilitation program and an intensive individual therapist-assisted back muscle strengthening exercise program used in Denmark have been reported to be effective for the treatment of CLBP. METHODS: A total of 286 patients with CLBP were randomized to either a group-based 12-week program comprising 73 hours of therapist exposure (approximately 12 h/patient): 35 hours of hard physical exercise, 22 hours of light exercise/occupational therapy, and 16 hours of education (group A) or a 12-week program comprising 1 hour of personal training twice a week, i.e., therapist exposure 24 h/patient (group B). At baseline and at 3, 6, 12, and 24 months, patients filled out questionnaires on pain (visual analogue scale [VAS]-pain average, which was the primary outcome measure), Roland-Morris disability questionnaire, global perceived outcome, and 36-Item Short-Form General Health Survey. Data were analyzed using the intention-to-treat principle. RESULTS: Of the 286 patients, 14 patients did not start treatment. Of the remaining patients, 25 (9%) dropped out of therapy. The 2 groups were comparable regarding baseline characteristic. After treatment, significant improvements were observed with regard to pain, disability, and most of the quality of life dimensions. These effects were sustained over the 24-month follow-up period. There were some statistically significant differences between the 2 groups relating to secondary end points, Roland-Morris disability questionnaire, and in the MOS 36-Item Short-Form Health Survey the "physical functioning" dimension and the "physical component summary." CONCLUSION: Both groups showed long-term improvements in pain and disability scores, with only minor statistically significant differences between the 2 groups. The minor outcome difference in favor of the group-based multidisciplinary rehabilitation program is hardly of clinical interest for individual patients.