United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: effectiveness of physical treatments for back pain in primary care
BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.38282.669225.AE (Published 09 December 2004) Cite this as: BMJ 2004;329:1377
- UK BEAM Trial Team (m.underwood{at}qmul.ac.uk)⇑
- Correspondence to: Martin Underwood, professor of general practice, Centre for General Practice and Primary Care, Institute of Community Health Sciences, Barts and the London, Queen Mary's School of Medicine and Dentistry, Queen Mary University of London, London E1 4NS
- Accepted 13 October 2004
Abstract
Objective To estimate the effect of adding exercise classes, spinal manipulation delivered in NHS or private premises, or manipulation followed by exercise to “best care” in general practice for patients consulting with back pain.
Design Pragmatic randomised trial with factorial design.
Setting 181 general practices in Medical Research Council General Practice Research Framework; 63 community settings around 14 centres across the United Kingdom.
Participants 1334 patients consulting their general practices about low back pain.
Main outcome measures Scores on the Roland Morris disability questionnaire at three and 12 months, adjusted for centre and baseline scores.
Results All groups improved over time. Exercise improved mean disability questionnaire scores at three months by 1.4 (95% confidence interval 0.6 to 2.1) more than “best care.” For manipulation the additional improvement was 1.6 (0.8 to 2.3) at three months and 1.0 (0.2 to 1.8) at 12 months. For manipulation followed by exercise the additional improvement was 1.9 (1.2 to 2.6) at three months and 1.3 (0.5 to 2.1) at 12 months. No significant differences in outcome occurred between manipulation in NHS premises and in private premises. No serious adverse events occurred.
Conclusions Relative to “best care” in general practice, manipulation followed by exercise achieved a moderate benefit at three months and a small benefit at 12 months; spinal manipulation achieved a small to moderate benefit at three months and a small benefit at 12 months; and exercise achieved a small benefit at three months but not 12 months.
Footnotes
Authorship details and a list of collaborators are on bmj.comWe thank all participants—patients, primary care staff, and the collaborators listed on bmj.com—for their contributions. Members of the UK BEAM Trial Team: Ian Russell, Martin Underwood, Stephen Brealey, Kim Burton, Simon Coulton, Amanda Farrin, Andrew Garratt, Emma Harvey, Louise Letley, Andrea Manca, Jeannett Martin, Jennifer Klaber Moffett, Veronica Morton, David Torgerson, Madge Vickers, Ken Whyte, Melanie Williams.
Contributors SB has been assistant trial manager at the York coordinating centre since August 2000. He contributed to collecting, validating, analysing and interpreting data, and drafting this paper. KB was a member of the MRC Back Pain Working Party, participated in the design and implementation of the trial, and was a member of the group that developed the spinal manipulation package. As joint national clinical coordinator, he was responsible for gaining the collaboration of the osteopathic profession in delivering this package and for implementing the resulting programme across the United Kingdom. He contributed to drafting this paper. SC was trial data manager, responsible for designing and implementing the data management plan and verifying and validating data. He contributed to implementing the trial design, developing and implementing randomisation procedures, developing questionnaires and other data collection instruments, analysing and interpreting data, and drafting this paper. AF was trial statistician, responsible for designing and implementing the analysis plan and validating data statistically. She contributed to implementing the trial design, developing and implementing randomisation procedures, developing questionnaires and other data collection instruments, analysing and interpreting data, and writing this paper. AG was a member of the MRC Back Pain Working Party, participated in the design and implementation of the trial, and was responsible for the evaluation and selection of the patient assessed health instruments. He contributed to developing questionnaires, analysing and interpreting data, and drafting this paper. EH was trial manager at the York coordinating centre, responsible for establishing and maintaining the 14 treatment centres and recruiting clinical advisers and local coordinators. She contributed to development and delivery of training in active management, implementing the “back to fitness” exercise programme, the spinal manipulation package, and the trial design; developing questionnaires and other materials; collecting, analysing, and interpreting data; and writing this paper. LL supervised the activities of practice based research nurses and coordinated nurse training. She contributed to implementing the trial design, selecting and recruiting practices for the trial, developing trial documentation including standard operating procedures, and drafting this paper. AM has been assistant trial economist since April 2002, responsible for designing and implementing the economic analysis plan. He estimated unit costs, analysed and interpreted economic data, and contributed to drafting this paper. JM had overall responsibility for all nursing activity within the trial including training and quality control through the GPRF regional training nurses. She contributed to implementing the trial design, selecting and recruiting practices, trial documentation including standard operating procedures, and drafting this paper. JKM was a member of the MRC Back Pain Working Party, participated in the design and implementation of the trial, contributed to the original grant application, and acted as grant holder responsible for physiotherapy within the trial. She developed the “back to fitness” exercise programme and was a member of the group that developed the spinal manipulation package. As joint national clinical coordinator, she was responsible for gaining the collaboration of the physiotherapy profession in both the exercise programme and the manipulation package and for implementing the exercise programme across the United Kingdom. She contributed to drafting this paper. VM has been assistant trial statistician since April 2002. She contributed to validating, analysing, and interpreting data and drafting this paper. IR was a member of the MRC Back Pain Working Party, participated in the design and implementation of the trial, was primarily responsible for the original grant application, and acted as grant holder and principal investigator in York. He chaired the trial management group and contributed to analysing and interpreting data and to writing this paper. He guarantees its statistical content. DT was trial economist, responsible for designing and implementing the economic evaluation and validating economic data. He contributed to implementing the trial design, developing questionnaires and other data collection instruments, analysing and interpreting data, and drafting this paper. MU was a member of the MRC Back Pain Working Party, participated in the design and implementation of the trial, contributed to the original grant application, and acted as grant holder responsible for medical aspects of the trial. He was trial manager at the London coordinating centre until October 1999, then joint national clinical coordinator. He contributed to developing questionnaires and developing other data collection instruments, the development and delivery of the training in active management, recruiting practices and participants, following up participants, managing, analysing and interpreting data, and writing this paper. He guarantees its clinical content. MV was a member of the MRC Back Pain Working Party, participated in the design and implementation of the trial, contributed to the original grant application, and acted as grant holder and principal investigator in London, responsible for recruiting practices and participants, and following up participants. She contributed to analysing and interpreting data and drafting this paper. KW has been trial manager at the London coordinating centre since October 1999. He was responsible for monitoring participant recruitment and for patient and practice based follow up procedures. He contributed to drafting this paper. MW was assistant trial manager at the York coordinating centre until August 2000 and acted as trial manager from then until April 2001. She was responsible for maintaining the 14 treatment centres, recruiting and training local coordinators, managing NHS treatment costs, and collecting and validating data. She contributed to drafting this paper.
Funding Medical Research Council (research costs); National Health Service in England, Northern Ireland, Scotland, and Wales (excess treatment and service support costs). The MRC established a trial steering committee to advise the grant holders and trial team on trial design; the collection, analysis, interpretation; and writing up of data; and publication policy.
Competing interests LL, JM, MU, MV, and KW have received salaries from the MRC. MU has received fees for speaking from Menarini Pharmaceuticals, the manufacturers of dexketoprofen and ketoprofen, and Pfizer, the manufacturers of celecoxib and valdecoxib. The other 12 authors have nothing to declare.
Ethical approval The Northern and Yorkshire multicentre research ethics committee and 41 local research ethics committees approved the trial protocol.
Amendment This is Version 2 of the paper. In this version, fig 1 has been amended so that the “manipulation” groups are correctly divided into “private manipulation” and “NHS manipulation” [in the previous version, all subgroups were labelled “private manipulation].