Randomised controlled trial of physiotherapy compared with advice for low back pain
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《英国医生杂志》
1 Division of Health in the Community, Warwick Medical School, University of Warwick, Warwick CV4 7AL, 2 Health Services Research Unit, Department of Public Health, University of Oxford, 3 Nuffield Orthopaedic Centre NHS Trust, Oxford
Correspondence to: H Frost h.frost.1@warwick.ac.uk
Abstract
Disability associated with low back pain is a major public health problem in Western societies.1-4 Back pain is the most common cause of physical disability in the working age population of the United Kingdom.2 In 1998, the direct healthcare costs for back pain in the United Kingdom were estimated at ￡1632m ($2932m; 2423m), with physiotherapy accounting for ￡251m.3 Physiotherapy is a tailored intervention that is usually focused on physical factors, including a combination of joint mobilisation, advice, and individual exercise programmes.5
Physiotherapists in the British NHS treat around 1.3 million people for low back pain each year, but there is only weak evidence for the effectiveness of routine physiotherapy and no evidence for the effectiveness of electrotherapy, laser treatment, ultrasound therapy, or traction.2 6
International guidelines vary but agree on advising patients with low back pain to remain physically active and prescribing appropriate analgesics. They recommend exercise therapy for patients with chronic low back pain (> 12 weeks' duration) and some suggest spinal manipulation for acute or subacute low back pain.7-9 We investigated the effectiveness of physiotherapy, as commonly practised in the British NHS, over a year for patients with low back pain compared with one session of assessment and advice from a physiotherapist.
Methods
Between October 1997 and January 2001 we randomised 286 (56.3%) of 508 patients who had been assessed for eligibility: 144 were allocated to therapy and 142 to advice only (fig 1). Table 1 lists the patients' characteristics. Although the advice only group had a slightly greater proportion of men and smokers, the groups were well balanced otherwise.
Table 1 Personal characteristics at baseline of 286 patients allocated to receive physiotherapy and advice for low back pain or advice only. Values are numbers (percentages) unless stated otherwise
Treatment
The patients were treated by 76 physiotherapists, reflecting the high turnover of staff in British NHS hospitals. About half (53%) of all treatments were carried out by 29 senior 1 therapists, 32% by 25 senior 2 therapists, and the remainder by junior grades. Treatment in the therapy group included joint mobilisation using low velocity thrusts (104 of 144 patients; 72%); soft tissue techniques (20; 14%); specific exercises (for example, McKenzie regimens),16 abdominal stability or strengthening exercises, and general mobility exercises for the lumbar spine (136; 94%); and heat (9; 6%) or cold treatment (4; 3%). The use of high velocity thrusts was rare (4; 3%).
Overall, 82% of patients in both groups complied with treatment. Patients in the therapy group received a median number of five (range 1-12) sessions, with 118 (82%) having six or fewer. Twenty six (18%) patients received more than six sessions as a result of decisions made by the physiotherapist. The median number of sessions in the advice only group was one (range 1-22). The number of single sessions was 116, with 26 patients receiving extra sessions either because they were unhappy with advice only (eight patients), because the physiotherapist deemed it unethical to withhold further treatment (for example, sudden increase in severe pain; four patients), or because the patient had been rereferred by his or her general practitioner for more treatment (two patients). No reason was given for extra sessions in the other patients.
Bias due to non-response
Overall, 30% of patients failed to provide data for the main outcome at 12 months. Only minor differences were found in the characteristics of people completing or not completing the Oswestry disability index at all follow up points: responders were older (mean age 43 (SD 15) v 37 (13); P < 0.001), less likely to smoke (39 (22%) v 50 (47%); P < 0.001), and more likely to have a first episode of back pain or a history of chronic back pain (39 (23%) v 14 (15%) and 43 (25%) v 14 (15%), respectively; P=0.009).
Flow of patients through trial
Outcome measures and patient perceived treatment benefit
We found no differences between the groups in change in scores on the Oswestry disability index at 12 months (mean difference -1.04, 95% confidence interval -3.7 to 1.59). Tables 2 and 3 show the results derived from the last value carried forward analysis.
Table 2 Mean (SD) change in disease specific scores at 2, 6, and 12 months from baseline for patients receiving physiotherapy or advice only for low back pain, with missing data replaced using last value carried forward
Table 3 Mean (SD) change in SF-36 domain scores at 2, 6 and 12 months from baseline for patients receiving physiotherapy or advice only for low back pain, with missing data replaced using last value carried forward
At 12 months the mean difference in domain scores on the SF-36 were: physical function (2.76, 95% confidence interval -1.91 to 7.42), role physical (0.68, -9.54 to 10.9), bodily pain (6.16, 0.45 to 11.9), general health (-0.31, -4.15 to 3.53), vitality (1.45, -2.41 to 5.32), social functioning (3.26, -2.39 to 8.91), role emotional (8.65, -0.87 to 18.2), and mental health (2.19, -1.59 to 5.97). Patients in the therapy group reported greater improvements for mental health and physical functioning at two months than the advice only group. On the basis of non-significant repeated measures analysis of covariance, however, these results are likely to be attributable to multiple testing. Overall, the data are consistent with no benefit from additional physiotherapy. Results from both methods of analysis were similar.
Patients in the therapy group were more likely to report benefits from treatment at both two and six months and also more benefit on the 0-10 rating scale at all time points than patients in the advice only group (table 4).
Table 4 Patient perceived benefits of treatment at 2, 6, and 12 months after randomisation, with missing data replaced using last value carried forward
Discussion
Klaber Moffett J, Richardson G, Sheldon TA, Maynard A. Back pain. Its management and cost to society. University of York: Centre for Health Economics, NHS Centre for Reviews and dissemination, 1995. (Discussion paper No 129.)
Clinical Standards Advisory Group. Epidemiology review: the epidemiology and cost of back pain. London: HMSO, 1994.
Maniadakis N, Gray A. The economic burden of back pain in the UK. Pain 2000;84: 95-103.
Knight M, Stewart-Brown S, Fletcher L. Estimating health needs: the impact of a checklist of conditions and quality of life measurement on health information derived from community surveys. J Public Health Med 2001;23: 179-86.
Foster N, Thompson K, Baxter G, Allen JM. Management of non-specific low back pain by therapists in Britain and Ireland. Spine 1999;24: 1332-42.
Bekkering GE, Hendriks HJM, Koes BW, Oostendorp RAB, Ostelo RWJG, Thomassen JMC, et al. Dutch physiotherapy guidelines for low back pain. Physiotherapy 2003;89(2): 82-96.
Koes BW, van Tulder MW, Ostelo R, Burton KA, Waddell G. Clinical guidelines for the management of low back pain in primary care. An international comparison. Spine 2001;26: 2504-14.
Van Tulder M, Malmivaara A, Esmail R, Koes B. Exercise therapy for low back pan. A systematic review within the framework of the Cochrane collaboration back review group. Spine 2000;25: 2784-96.
Clinical Standards Advisory Group. Back pain. London: HMSO, 1994.
Fairbank J, Pynsent P. The Oswestry disability index. Spine 2000;25: 2940-53.
Roland M, Morris R. A study of the natural history of back pain. Part 1: development of a reliable and sensitive measure of disability in low back pain. Spine 1993;8: 141-4.
Brazier JE, Harper R, Jones NMB, Ocathain A, Thomas KJ, Usherwood T, et al. Validating the SF-36 health survey questionnaire; new outcome measure for primary care. BMJ 1992;305: 160-4.
The back book. London: Stationery Office, 1997.
Pocock SJ. Clinical trials. A practical approach. Chichester: Wiley, 1983.
Kirkwood BR. Essentials of medical statistics. Oxford: Blackwell, 1990.
McKenzie RA. The lumbar spine: mechanical diagnosis and therapy. Waikanae, New Zealand: Spine, 1981.
Little P, Roberts L, Blowers H, Garwood J, Cantrell T, Langridge J, et al. Should we give detailed advice and information booklets to patients with back pain? A randomised controlled factorial trial of self management booklet and doctor advice to take exercise for back pain. Spine 2001;26: 2065-72.
Burton AK, Waddell G, Tillotson KM, Summerton N, Information and advice to patients with back pain can have a positive effect: a randomised controlled trial of a novel educational booklet in primary care. Spine 1999;24: 2484-91.
Peterson T, Kryger P, Ekdahl C, Olsen S, Jacobsen S. The effect of McKenzie therapy as compared with that of intensive strengthening training for the treatment of patients with sub-acute or chronic low back pain. Spine 2002;27: 1702-9.
Prescott RJ, Counsell CE, Gillespie WJ, Grant AM, Russell IT, Kiauka S, et al. Factors that limit the quantity, number and progress of randomised controlled trials Health Technol Assess 1999;3: 71.
Ong C-K, Doll H, Bodeker G, Stewart-Brown S. Use of osteopathy or chiropractic services among people with back pain: a UK population survey. Health Soc Care Community 2004;12: 265-73.
Klaber Moffett J, Torgerson D, Bell-Syer S, Lackson D, Llewlyn-Phllips H, Farrin A, et al. Randomised controlled trial of exercise for low back pain: clinical outcomes, costs and preferences. BMJ 1999;319: 270-83.(Helen Frost, research fel)
Correspondence to: H Frost h.frost.1@warwick.ac.uk
Abstract
Disability associated with low back pain is a major public health problem in Western societies.1-4 Back pain is the most common cause of physical disability in the working age population of the United Kingdom.2 In 1998, the direct healthcare costs for back pain in the United Kingdom were estimated at ￡1632m ($2932m; 2423m), with physiotherapy accounting for ￡251m.3 Physiotherapy is a tailored intervention that is usually focused on physical factors, including a combination of joint mobilisation, advice, and individual exercise programmes.5
Physiotherapists in the British NHS treat around 1.3 million people for low back pain each year, but there is only weak evidence for the effectiveness of routine physiotherapy and no evidence for the effectiveness of electrotherapy, laser treatment, ultrasound therapy, or traction.2 6
International guidelines vary but agree on advising patients with low back pain to remain physically active and prescribing appropriate analgesics. They recommend exercise therapy for patients with chronic low back pain (> 12 weeks' duration) and some suggest spinal manipulation for acute or subacute low back pain.7-9 We investigated the effectiveness of physiotherapy, as commonly practised in the British NHS, over a year for patients with low back pain compared with one session of assessment and advice from a physiotherapist.
Methods
Between October 1997 and January 2001 we randomised 286 (56.3%) of 508 patients who had been assessed for eligibility: 144 were allocated to therapy and 142 to advice only (fig 1). Table 1 lists the patients' characteristics. Although the advice only group had a slightly greater proportion of men and smokers, the groups were well balanced otherwise.
Table 1 Personal characteristics at baseline of 286 patients allocated to receive physiotherapy and advice for low back pain or advice only. Values are numbers (percentages) unless stated otherwise
Treatment
The patients were treated by 76 physiotherapists, reflecting the high turnover of staff in British NHS hospitals. About half (53%) of all treatments were carried out by 29 senior 1 therapists, 32% by 25 senior 2 therapists, and the remainder by junior grades. Treatment in the therapy group included joint mobilisation using low velocity thrusts (104 of 144 patients; 72%); soft tissue techniques (20; 14%); specific exercises (for example, McKenzie regimens),16 abdominal stability or strengthening exercises, and general mobility exercises for the lumbar spine (136; 94%); and heat (9; 6%) or cold treatment (4; 3%). The use of high velocity thrusts was rare (4; 3%).
Overall, 82% of patients in both groups complied with treatment. Patients in the therapy group received a median number of five (range 1-12) sessions, with 118 (82%) having six or fewer. Twenty six (18%) patients received more than six sessions as a result of decisions made by the physiotherapist. The median number of sessions in the advice only group was one (range 1-22). The number of single sessions was 116, with 26 patients receiving extra sessions either because they were unhappy with advice only (eight patients), because the physiotherapist deemed it unethical to withhold further treatment (for example, sudden increase in severe pain; four patients), or because the patient had been rereferred by his or her general practitioner for more treatment (two patients). No reason was given for extra sessions in the other patients.
Bias due to non-response
Overall, 30% of patients failed to provide data for the main outcome at 12 months. Only minor differences were found in the characteristics of people completing or not completing the Oswestry disability index at all follow up points: responders were older (mean age 43 (SD 15) v 37 (13); P < 0.001), less likely to smoke (39 (22%) v 50 (47%); P < 0.001), and more likely to have a first episode of back pain or a history of chronic back pain (39 (23%) v 14 (15%) and 43 (25%) v 14 (15%), respectively; P=0.009).
Flow of patients through trial
Outcome measures and patient perceived treatment benefit
We found no differences between the groups in change in scores on the Oswestry disability index at 12 months (mean difference -1.04, 95% confidence interval -3.7 to 1.59). Tables 2 and 3 show the results derived from the last value carried forward analysis.
Table 2 Mean (SD) change in disease specific scores at 2, 6, and 12 months from baseline for patients receiving physiotherapy or advice only for low back pain, with missing data replaced using last value carried forward
Table 3 Mean (SD) change in SF-36 domain scores at 2, 6 and 12 months from baseline for patients receiving physiotherapy or advice only for low back pain, with missing data replaced using last value carried forward
At 12 months the mean difference in domain scores on the SF-36 were: physical function (2.76, 95% confidence interval -1.91 to 7.42), role physical (0.68, -9.54 to 10.9), bodily pain (6.16, 0.45 to 11.9), general health (-0.31, -4.15 to 3.53), vitality (1.45, -2.41 to 5.32), social functioning (3.26, -2.39 to 8.91), role emotional (8.65, -0.87 to 18.2), and mental health (2.19, -1.59 to 5.97). Patients in the therapy group reported greater improvements for mental health and physical functioning at two months than the advice only group. On the basis of non-significant repeated measures analysis of covariance, however, these results are likely to be attributable to multiple testing. Overall, the data are consistent with no benefit from additional physiotherapy. Results from both methods of analysis were similar.
Patients in the therapy group were more likely to report benefits from treatment at both two and six months and also more benefit on the 0-10 rating scale at all time points than patients in the advice only group (table 4).
Table 4 Patient perceived benefits of treatment at 2, 6, and 12 months after randomisation, with missing data replaced using last value carried forward
Discussion
Klaber Moffett J, Richardson G, Sheldon TA, Maynard A. Back pain. Its management and cost to society. University of York: Centre for Health Economics, NHS Centre for Reviews and dissemination, 1995. (Discussion paper No 129.)
Clinical Standards Advisory Group. Epidemiology review: the epidemiology and cost of back pain. London: HMSO, 1994.
Maniadakis N, Gray A. The economic burden of back pain in the UK. Pain 2000;84: 95-103.
Knight M, Stewart-Brown S, Fletcher L. Estimating health needs: the impact of a checklist of conditions and quality of life measurement on health information derived from community surveys. J Public Health Med 2001;23: 179-86.
Foster N, Thompson K, Baxter G, Allen JM. Management of non-specific low back pain by therapists in Britain and Ireland. Spine 1999;24: 1332-42.
Bekkering GE, Hendriks HJM, Koes BW, Oostendorp RAB, Ostelo RWJG, Thomassen JMC, et al. Dutch physiotherapy guidelines for low back pain. Physiotherapy 2003;89(2): 82-96.
Koes BW, van Tulder MW, Ostelo R, Burton KA, Waddell G. Clinical guidelines for the management of low back pain in primary care. An international comparison. Spine 2001;26: 2504-14.
Van Tulder M, Malmivaara A, Esmail R, Koes B. Exercise therapy for low back pan. A systematic review within the framework of the Cochrane collaboration back review group. Spine 2000;25: 2784-96.
Clinical Standards Advisory Group. Back pain. London: HMSO, 1994.
Fairbank J, Pynsent P. The Oswestry disability index. Spine 2000;25: 2940-53.
Roland M, Morris R. A study of the natural history of back pain. Part 1: development of a reliable and sensitive measure of disability in low back pain. Spine 1993;8: 141-4.
Brazier JE, Harper R, Jones NMB, Ocathain A, Thomas KJ, Usherwood T, et al. Validating the SF-36 health survey questionnaire; new outcome measure for primary care. BMJ 1992;305: 160-4.
The back book. London: Stationery Office, 1997.
Pocock SJ. Clinical trials. A practical approach. Chichester: Wiley, 1983.
Kirkwood BR. Essentials of medical statistics. Oxford: Blackwell, 1990.
McKenzie RA. The lumbar spine: mechanical diagnosis and therapy. Waikanae, New Zealand: Spine, 1981.
Little P, Roberts L, Blowers H, Garwood J, Cantrell T, Langridge J, et al. Should we give detailed advice and information booklets to patients with back pain? A randomised controlled factorial trial of self management booklet and doctor advice to take exercise for back pain. Spine 2001;26: 2065-72.
Burton AK, Waddell G, Tillotson KM, Summerton N, Information and advice to patients with back pain can have a positive effect: a randomised controlled trial of a novel educational booklet in primary care. Spine 1999;24: 2484-91.
Peterson T, Kryger P, Ekdahl C, Olsen S, Jacobsen S. The effect of McKenzie therapy as compared with that of intensive strengthening training for the treatment of patients with sub-acute or chronic low back pain. Spine 2002;27: 1702-9.
Prescott RJ, Counsell CE, Gillespie WJ, Grant AM, Russell IT, Kiauka S, et al. Factors that limit the quantity, number and progress of randomised controlled trials Health Technol Assess 1999;3: 71.
Ong C-K, Doll H, Bodeker G, Stewart-Brown S. Use of osteopathy or chiropractic services among people with back pain: a UK population survey. Health Soc Care Community 2004;12: 265-73.
Klaber Moffett J, Torgerson D, Bell-Syer S, Lackson D, Llewlyn-Phllips H, Farrin A, et al. Randomised controlled trial of exercise for low back pain: clinical outcomes, costs and preferences. BMJ 1999;319: 270-83.(Helen Frost, research fel)