A pragmatic cluster randomized controlled trial in primary care.
The aim of this study was to estimate the clinical effectiveness and cost-effectiveness of a cognitive-based education program on patients with subacute or chronic low back pain (LBP) in primary care, compared to usual treatment, provided by general practitioners (GP) and physiotherapists (PT).
Patient education has been reported to have a favorable effect on patients with chronic musculoskeletal disorders. In this study, an “Explain Pain” model was adapted to fit into an ordinary clinical setting in Norwegian primary care.
Sixteen GPs and 20 PTs participated in the study and a total of 216 patients were recruited. The GPs and PTs were randomly assigned to provide either a cognitive patient education or usual treatment. All patients in both groups were provided with four consultations of 30 min with their provider during the study. In the intervention group the patients were educated according to a specific manual written for the purpose of this study.
Eighty-one percent responded at 4-week, and 68% at the 12-month follow-up. There was a substantial improvement in function, pain, and sick leave in both groups. After 4 weeks the intervention group scored 0.51 RMDQ points lower than the control group (Beta –0.506 [95% CI –1.76–0.75]). After 12 months the intervention group scored 0.66 RMDQ points higher than the control group (Beta 0.66 [95% CI −0.56–1.88]). There was no significant difference in QALYs in the two treatment groups; the estimated difference was 0.005 (−0.016–0.027) in favor of the intervention.
This study showed no clinical or health economic benefits as a result of adding a cognitive education program to usual treatment for patients with subacute and chronic LBP. Potential weaknesses such as a long recruiting period and potentially low compliance with the cognitive intervention warrant a careful interpretation of the results.
Level of Evidence: 3
*Department of General Practice, Institute of Health and Society, University of Oslo, Norway
†Research Unit for General Practice, Uni Research Health, Uni Research, Bergen, Norway
‡FORMI, Clinic for Surgery and Neurology, Oslo University Hospital, Norway
§Department of Clinical Medicine, University of Oslo, Norway
¶Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Norway
||Department of Health Management and Health Economics, University of Oslo, Norway
**Department of Physiotherapy, Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Norway.
Address correspondence and reprint requests to Erik L. Werner, MD, PhD, Department of General Practice, University of Oslo, P.O. Box 1130 Blindern, Oslo, Norway; E-mail: email@example.com
Received 25 June, 2015
Revised 14 September, 2015
Accepted 15 September, 2015
The manuscript submitted does not contain information about medical device(s)/drug(s).
The Norwegian Research Council and the Norwegian Medical Association's foundation funds were received in support of this work.
No relevant financial activities outside the submitted work.