United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: effectiveness of physical treatments for back pain in primary
http://www.100md.com
《英国医生杂志》
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 m.underwood@qmul.ac.uk
Abstract
Back pain is a common and costly problem.1 The role of different physical treatments is not clear. Evidence suggests that encouraging patients to keep active is effective,2 but evidence for the effectiveness of spinal manipulation is conflicting.3 4 Although specific exercises seem to be ineffective,3 weak evidence exists for general programmes that encourage physical activity as a treatment for back pain.2 5
This trial compared a class based general exercise programme and a spinal manipulation package with "best care" in general practice, based on "active management." A previous UK trial reported that treatment by private chiropractors was superior to routine outpatient care,6 but the trial received criticism for not considering the potentially biasing effect of treatment location.7 Therefore, we also compared the effect of manipulation delivered in private premises with that of manipulation in premises owned by the NHS.
Our main aim was to estimate, for patients consulting their general practitioner with back pain, the effectiveness of adding the following to best care in general practice8: a class based exercise programme ("back to fitness"),9 a package of treatment by a spinal manipulator (chiropractor, osteopath, or physiotherapist),10 or manipulation followed by exercise. We also aimed to test whether the manipulation package was more or less effective in manipulators' private premises than in NHS premises.
Methods
Participant flow and follow up
We recruited 1334 participants from 181 general practices around 14 centres across the United Kingdom (fig 1). These practices were broadly typical of UK practices in size and deprivation. The feasibility study recruited 164 participants between March 1998 and April 1999.11 The main trial recruited 1170 participants between August 1999 and April 2001. These participants attended exercise classes in 18 community settings and received manipulation in 45 premises, 27 private and 18 owned by the NHS. At three months, 1029 (77%) returned questionnaires; at 12 months, 995 (75%) returned questionnaires. Responders were much more likely than non-responders to be female, above average age, and educated beyond age 16 and to have had severe back pain at randomisation. As these trends were consistent across randomised groups, however, little risk of bias exists.
Baseline data
The mean (SD) age of participants at randomisation was 43 (11) years; 56% were female, and 9% were not working because of poor health. More than half had had pain for more than 90 days. Mean (SD) Roland disability score at randomisation was 9.0. The six randomised groups had similar characteristics (table 1).
Process
The message about active management reached most participants: when asked at randomisation, 1160 (87%) recalled seeing The Back Book.14 Of 686 participants allocated to manipulation, 633 (92%) received "basic minimum treatment." Of 643 participants allocated to exercise, 408 (63%) received basic minimum treatment. No serious adverse events occurred.
Analysis
Roland disability questionnaire scores improved by a mean (SD) of 3.3 (4.5) points at three months and 3.5 (4.7) points at 12 months. Figure 2 shows progress in disability scores following randomisation between the four basic interventions.
Fig 2 Mean Roland disability questionnaire scores (with 95% confidence intervals) over 12 months by group: "best care" in general practice, best care plus exercise alone, best care plus manipulation alone, and best care plus manipulation and exercise
Exercise programme
Exercise produced statistically significant improvements in mean Roland disability score at three months only (difference = 1.4; 95% confidence interval 0.6 to 2.1), in mean Von Korff disability and pain scores and back beliefs score at both three and 12 months, and in mean SF-36 physical score and fear avoidance beliefs physical score at three months only (table 2). Mean SF-36 mental score did not differ.
Manipulation package
Manipulation produced statistically significant improvements in Roland disability scores at three months (1.6; 0.8 to 2.3) and at one year (1.0; 0.2 to 1.8); in mean Von Korff pain score, back beliefs score, and SF-36 physical score at both three and 12 months; in mean Von Korff disability score at 12 months only; and in mean SF-36 mental score at three months only (table 3). Mean fear avoidance beliefs physical score did not differ.
We found no significant differences between the outcome of manipulation delivered in NHS or private premises. The adjusted difference in disability scores was 0.2 (-0.6 to 0.9) in favour of private premises at three months and 0.1 (-0.7 to 0.9) in favour of NHS premises at 12 months.
Manipulation followed by exercise
Manipulation followed by exercise produced significant improvements in Roland disability scores at three months (1.9; 1.2 to 2.6) and at one year (1.3; 0.5 to 2.1); in mean Von Korff disability and pain scores and back beliefs, fear avoidance beliefs, and SF-36 physical scores at both three and 12 months; but in mean SF-36 mental score only at three months (table 4). Three of these 13 significant improvements were significantly greater than the corresponding improvements from manipulation without exercise—in fear avoidance beliefs scores at three and 12 months and back beliefs scores at 12 months.
Discussion
Maniadakis N, Gray A. The economic burden of back pain in the UK. Pain 2000;84: 95-103.
Waddell G, Feder G, McIntosh G, Lewis M, Hutchinson A. Low back pain evidence review. London: Royal College of General Practitioners, 1999.
Van Tulder MW, Koes BW, Bouter LM. Conservative treatment of acute and chronic nonspecific low back pain: a systematic review of randomized controlled trials of the most common interventions. Spine 1997;22: 2128-56.
Assendelft WJ, Morton SC, Yu EI, Suttorp MJ, Shekelle PG. Spinal manipulative therapy for low back pain: a meta-analysis of effectiveness relative to other therapies. Ann Intern Med 2003;138: 871-81.
Van Tulder M, Malmivaara A, Esmail R, Koes B. Exercise therapy for low back pain: a systematic review within the framework of the Cochrane Collaboration Back Review Group. Spine 2000;25: 2784-96.
Meade TW, Dyer S, Browne W, Townsend J, Frank AO. Low back pain of mechanical origin: randomised comparison of chiropractic and hospital outpatient treatment. BMJ 1990;300: 1431-7.
Assendelft WJ, Bouter LM, Kessels AG. Effectiveness of chiropractic and physiotherapy in the treatment of low back pain: a critical discussion of the British randomized clinical trial. J Manipulative Physiol Ther 1991;14: 281-6.
Underwood M, O'Meara S, Harvey E, UK BEAM Trial Team. The acceptability to primary care staff of a multidisciplinary training package on acute back pain guidelines. Fam Pract 2002;19: 511-5.
Klaber Moffett J, Frost H, UK BEAM Trial Team. Back to fitness programme: the manual for physiotherapists to set up the classes. Physiotherapy 2000;85: 295-305.
Harvey E, Burton AK, Moffett JK, Breen A, UK BEAM Trial Team. Spinal manipulation for low back pain: a treatment package agreed by the UK chiropractic, osteopathy and physiotherapy professional associations. Man Ther 2003;8: 46-51.
UK BEAM Trial Team. UK back pain exercise and manipulation (UK BEAM) trial—national randomised trial of physical treatments for back pain in primary care: objectives, design and intervention. BMC Health Serv Res 2003;3: 16.
Knipschild P, Leffers P, Feinstein AR. The qualification period. J Clin Epidemiol 1991;44: 461-4.
Koes BW, van Tulder MW, Ostelo R, Burton AK, Waddell G. Clinical guidelines for the management of low back pain in primary care. Spine 2001;26: 2504-14.
Roland M, Waddell G, Klaber Moffett J, Burton AK, Main CJ, Cantrell T. The back book. Norwich: Stationery Office, 1996.
Frost H, Klaber Moffett J, Moser JS, Fairbank JC. Randomised controlled trial for evaluation of fitness programme for patients with chronic low back pain. BMJ 1995;310: 151-4.
Klaber Moffett J, Torgerson D, Bell-Syer S, Jackson D, Llewlyn-Phillips H, Farrin A, et al. Randomised controlled trial of exercise for low back pain: clinical outcomes, costs, and preferences. BMJ 1999;319: 279-83.
Roland M, Morris R. A study of the natural history of back pain. I: development of a reliable and sensitive measure of disability in low-back pain. Spine 1983;8: 141-4.
Underwood MR, Barnett AG, Vickers MR. Evaluation of two time-specific back pain outcome measures. Spine 1999;24: 1104-12.
Symonds TL, Burton AK, Tillotson KM, Main CJ. Do attitudes and beliefs influence work loss due to low back trouble? Occup Med 1996;46: 25-32.
Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A fear-avoidance beliefs questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain 1993;52: 157-68.
Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I: conceptual framework and item selection. Med Care 1992;30: 473-83.
The EuroQol Group. EuroQol—a new facility for the measurement of health-related quality of life. Health Policy 1990;16: 199-208.
UK BEAM Trial Team. United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: cost effectiveness of physical treatments for back pain in primary care. BMJ 2004;329:doi:10.1136/bmj.38282.607859.AE.
Bombardier C, Hayden J, Beaton DE. Minimal clinically important difference in low back pain outcome measures. J Rheumatol 2001;28: 431-8.(UK BEAM Trial Team)
Abstract
Back pain is a common and costly problem.1 The role of different physical treatments is not clear. Evidence suggests that encouraging patients to keep active is effective,2 but evidence for the effectiveness of spinal manipulation is conflicting.3 4 Although specific exercises seem to be ineffective,3 weak evidence exists for general programmes that encourage physical activity as a treatment for back pain.2 5
This trial compared a class based general exercise programme and a spinal manipulation package with "best care" in general practice, based on "active management." A previous UK trial reported that treatment by private chiropractors was superior to routine outpatient care,6 but the trial received criticism for not considering the potentially biasing effect of treatment location.7 Therefore, we also compared the effect of manipulation delivered in private premises with that of manipulation in premises owned by the NHS.
Our main aim was to estimate, for patients consulting their general practitioner with back pain, the effectiveness of adding the following to best care in general practice8: a class based exercise programme ("back to fitness"),9 a package of treatment by a spinal manipulator (chiropractor, osteopath, or physiotherapist),10 or manipulation followed by exercise. We also aimed to test whether the manipulation package was more or less effective in manipulators' private premises than in NHS premises.
Methods
Participant flow and follow up
We recruited 1334 participants from 181 general practices around 14 centres across the United Kingdom (fig 1). These practices were broadly typical of UK practices in size and deprivation. The feasibility study recruited 164 participants between March 1998 and April 1999.11 The main trial recruited 1170 participants between August 1999 and April 2001. These participants attended exercise classes in 18 community settings and received manipulation in 45 premises, 27 private and 18 owned by the NHS. At three months, 1029 (77%) returned questionnaires; at 12 months, 995 (75%) returned questionnaires. Responders were much more likely than non-responders to be female, above average age, and educated beyond age 16 and to have had severe back pain at randomisation. As these trends were consistent across randomised groups, however, little risk of bias exists.
Baseline data
The mean (SD) age of participants at randomisation was 43 (11) years; 56% were female, and 9% were not working because of poor health. More than half had had pain for more than 90 days. Mean (SD) Roland disability score at randomisation was 9.0. The six randomised groups had similar characteristics (table 1).
Process
The message about active management reached most participants: when asked at randomisation, 1160 (87%) recalled seeing The Back Book.14 Of 686 participants allocated to manipulation, 633 (92%) received "basic minimum treatment." Of 643 participants allocated to exercise, 408 (63%) received basic minimum treatment. No serious adverse events occurred.
Analysis
Roland disability questionnaire scores improved by a mean (SD) of 3.3 (4.5) points at three months and 3.5 (4.7) points at 12 months. Figure 2 shows progress in disability scores following randomisation between the four basic interventions.
Fig 2 Mean Roland disability questionnaire scores (with 95% confidence intervals) over 12 months by group: "best care" in general practice, best care plus exercise alone, best care plus manipulation alone, and best care plus manipulation and exercise
Exercise programme
Exercise produced statistically significant improvements in mean Roland disability score at three months only (difference = 1.4; 95% confidence interval 0.6 to 2.1), in mean Von Korff disability and pain scores and back beliefs score at both three and 12 months, and in mean SF-36 physical score and fear avoidance beliefs physical score at three months only (table 2). Mean SF-36 mental score did not differ.
Manipulation package
Manipulation produced statistically significant improvements in Roland disability scores at three months (1.6; 0.8 to 2.3) and at one year (1.0; 0.2 to 1.8); in mean Von Korff pain score, back beliefs score, and SF-36 physical score at both three and 12 months; in mean Von Korff disability score at 12 months only; and in mean SF-36 mental score at three months only (table 3). Mean fear avoidance beliefs physical score did not differ.
We found no significant differences between the outcome of manipulation delivered in NHS or private premises. The adjusted difference in disability scores was 0.2 (-0.6 to 0.9) in favour of private premises at three months and 0.1 (-0.7 to 0.9) in favour of NHS premises at 12 months.
Manipulation followed by exercise
Manipulation followed by exercise produced significant improvements in Roland disability scores at three months (1.9; 1.2 to 2.6) and at one year (1.3; 0.5 to 2.1); in mean Von Korff disability and pain scores and back beliefs, fear avoidance beliefs, and SF-36 physical scores at both three and 12 months; but in mean SF-36 mental score only at three months (table 4). Three of these 13 significant improvements were significantly greater than the corresponding improvements from manipulation without exercise—in fear avoidance beliefs scores at three and 12 months and back beliefs scores at 12 months.
Discussion
Maniadakis N, Gray A. The economic burden of back pain in the UK. Pain 2000;84: 95-103.
Waddell G, Feder G, McIntosh G, Lewis M, Hutchinson A. Low back pain evidence review. London: Royal College of General Practitioners, 1999.
Van Tulder MW, Koes BW, Bouter LM. Conservative treatment of acute and chronic nonspecific low back pain: a systematic review of randomized controlled trials of the most common interventions. Spine 1997;22: 2128-56.
Assendelft WJ, Morton SC, Yu EI, Suttorp MJ, Shekelle PG. Spinal manipulative therapy for low back pain: a meta-analysis of effectiveness relative to other therapies. Ann Intern Med 2003;138: 871-81.
Van Tulder M, Malmivaara A, Esmail R, Koes B. Exercise therapy for low back pain: a systematic review within the framework of the Cochrane Collaboration Back Review Group. Spine 2000;25: 2784-96.
Meade TW, Dyer S, Browne W, Townsend J, Frank AO. Low back pain of mechanical origin: randomised comparison of chiropractic and hospital outpatient treatment. BMJ 1990;300: 1431-7.
Assendelft WJ, Bouter LM, Kessels AG. Effectiveness of chiropractic and physiotherapy in the treatment of low back pain: a critical discussion of the British randomized clinical trial. J Manipulative Physiol Ther 1991;14: 281-6.
Underwood M, O'Meara S, Harvey E, UK BEAM Trial Team. The acceptability to primary care staff of a multidisciplinary training package on acute back pain guidelines. Fam Pract 2002;19: 511-5.
Klaber Moffett J, Frost H, UK BEAM Trial Team. Back to fitness programme: the manual for physiotherapists to set up the classes. Physiotherapy 2000;85: 295-305.
Harvey E, Burton AK, Moffett JK, Breen A, UK BEAM Trial Team. Spinal manipulation for low back pain: a treatment package agreed by the UK chiropractic, osteopathy and physiotherapy professional associations. Man Ther 2003;8: 46-51.
UK BEAM Trial Team. UK back pain exercise and manipulation (UK BEAM) trial—national randomised trial of physical treatments for back pain in primary care: objectives, design and intervention. BMC Health Serv Res 2003;3: 16.
Knipschild P, Leffers P, Feinstein AR. The qualification period. J Clin Epidemiol 1991;44: 461-4.
Koes BW, van Tulder MW, Ostelo R, Burton AK, Waddell G. Clinical guidelines for the management of low back pain in primary care. Spine 2001;26: 2504-14.
Roland M, Waddell G, Klaber Moffett J, Burton AK, Main CJ, Cantrell T. The back book. Norwich: Stationery Office, 1996.
Frost H, Klaber Moffett J, Moser JS, Fairbank JC. Randomised controlled trial for evaluation of fitness programme for patients with chronic low back pain. BMJ 1995;310: 151-4.
Klaber Moffett J, Torgerson D, Bell-Syer S, Jackson D, Llewlyn-Phillips H, Farrin A, et al. Randomised controlled trial of exercise for low back pain: clinical outcomes, costs, and preferences. BMJ 1999;319: 279-83.
Roland M, Morris R. A study of the natural history of back pain. I: development of a reliable and sensitive measure of disability in low-back pain. Spine 1983;8: 141-4.
Underwood MR, Barnett AG, Vickers MR. Evaluation of two time-specific back pain outcome measures. Spine 1999;24: 1104-12.
Symonds TL, Burton AK, Tillotson KM, Main CJ. Do attitudes and beliefs influence work loss due to low back trouble? Occup Med 1996;46: 25-32.
Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A fear-avoidance beliefs questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain 1993;52: 157-68.
Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I: conceptual framework and item selection. Med Care 1992;30: 473-83.
The EuroQol Group. EuroQol—a new facility for the measurement of health-related quality of life. Health Policy 1990;16: 199-208.
UK BEAM Trial Team. United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: cost effectiveness of physical treatments for back pain in primary care. BMJ 2004;329:doi:10.1136/bmj.38282.607859.AE.
Bombardier C, Hayden J, Beaton DE. Minimal clinically important difference in low back pain outcome measures. J Rheumatol 2001;28: 431-8.(UK BEAM Trial Team)