The effect of an integrated multidisciplinary rehabilitation programme alternating inpatient interventions with home-based activities for patients with chronic low back pain: a randomized controlled trial

Abstract

Objective: To compare the effectiveness of an integrated rehabilitation programme with an existing rehabilitation programme in patients with chronic low back pain. Design: A single-centre, pragmatic, two-arm parallel, randomized controlled trial (1:1 ratio). Setting: A rheumatology inpatient rehabilitation centre in Denmark. Subjects: A total of 165 adults (aged ⩾ 18 years) with chronic low back pain. Interventions: An integrated rehabilitation programme comprising an alternation of three weeks of inpatient stay and 12 weeks of home-based activities was compared with an existing rehabilitation programme of four weeks of inpatient stay. Main measures: Patient-reported outcomes were collected at baseline and at the 26-week follow-up. The primary outcome was back-specific disability (Oswestry Disability Index). Secondary outcomes included pain intensity (Numerical Rating Scale), pain self-efficacy (Pain Self-Efficacy Questionnaire), health-related quality of life (EuroQol-5 Domain 5-level (EQ-5D)), and depression (Major Depression Inventory). A complete case analysis was performed. Results: A total of 303 patients were assessed for eligibility of whom 165 (mean age: 50 years (SD 13) and mean Oswestry Disability Index score 42 (SD 11)) were randomized (83 to existing rehabilitation programme and 82 to integrated rehabilitation programme). Overall, 139 patients provided the 26-week follow-up data. Baseline demographic and clinical characteristics were comparable between programmes. The between-group difference in the Oswestry Disability Index score when adjusting for the corresponding baseline score was −0.28 (95% confidence interval (CI): −4.02, 3.45) which was neither statistically nor clinically significant. No significant differences were found in the secondary outcomes. Conclusion: An integrated rehabilitation programme was no more effective than an existing rehabilitation programme at the 26-week follow-up.