Abstract
OBJECTIVE: To compare the effectiveness of a physiotherapy programme with a control treatment of advice and education in patients with neurogenic claudication symptoms. DESIGN: Pragmatic randomised controlled clinical trial. SETTING: Primary care-based musculoskeletal service. PATIENTS: Adults aged 50 or over with neurogenic claudication symptoms causing limitation of walking. INTERVENTIONS: Condition-specific home exercises combined with advice and education, or advice and education alone. MAIN OUTCOME MEASURES: The primary outcome was the difference in improvement of symptom severity scores on the Swiss Spinal Stenosis Scale at eight weeks. Secondary outcomes included measures of physical function, pain and general well-being at eight weeks and 12 months. RESULTS: There was no significant difference between groups in the Swiss Spinal Stenosis symptom severity scale at eight weeks (t = 0.47, p = 0.643): mean change (SD) control group -0.18 (0.47), treatment group -0.10 (0.66), difference (95% CI) 0.08 (-0.19, 0.35); baseline-adjusted difference 0.06 (-0.19, 0.31)]. An unplanned subgroup analysis suggested that for patients with the top 25% of baseline symptom severity scores, the physiotherapy exercise programme resulted in an improvement in the primary outcome, and modest but consistently better secondary outcomes at both time-points compared to the control group. The effectiveness in different subgroups requires further direct evaluation. CONCLUSIONS: In the treatment of patients with neurogenic claudication symptoms, a physiotherapist-prescribed home exercise programme is no more effective than advice and education. ETHICAL APPROVAL: The study was approved by Leeds Central Ethics Committee and informed consent was given by all participating patients. COPYRIGHT: The Corresponding Author has the right to grant on behalf of all authors and does grant on behalf of all authors, a worldwide licence to the Publishers and its licensees in perpetuity, in all forms, formats and media (whether known now or created in the future), to i) publish, reproduce, distribute, display and store the Contribution, ii) translate the Contribution into other languages, create adaptations, reprints, include within collections and create summaries, extracts and/or, abstracts of the Contribution, iii) create any other derivative work(s) based on the Contribution, iv) to exploit all subsidiary rights in the Contribution, v) the inclusion of electronic links from the Contribution to third party material where-ever it may be located; and, vi) licence any third party to do any or all of the above. TRIAL REGISTRATION: ISRCTN 78288224 - doi10.1186/ISRCTN35836727; UKCRN 4814.