Randomised trial of a brief physiotherapy intervention compared with u
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《英国医生杂志》
1 Institute of Rehabilitation, University of Hull, Hull HU3 2PG, 2 Department of Public Health and Primary Care, University of Hull, Hull HU6 7RX, 3 Department of Health Sciences, University of York, York YO10 5DD, 4 Centre for Health Economics, University of York
Correspondence to: J K Moffett j.k.moffett@hull.ac.uk
Abstract
Neck pain accounts for 15% of all soft tissue problems seen in general practice1 and is a common reason for referral for physiotherapy treatment. In any one year, 30% of adults will report neck pain, and 5-10% will be disabled with it.2 3 Although neck pain has been regarded as self limiting and benign, it consumes a substantial proportion of healthcare resources.4 A recent survey of 10 community physiotherapy departments in the east Yorkshire area has shown that of 7899 subjects referred, 1060 (13.4%) had neck complaints. Most physiotherapists in the United Kingdom provide between four and 10 treatment sessions for spinal problems such as back pain,5 whereas in the United States they provide between nine and 12 treatment sessions.6 Little evidence is available, however, with respect to the effectiveness and cost effectiveness of routinely used physiotherapy interventions for neck pain.7 A criteria based appraisal of review articles reported finding 12 systematic reviews on the management of neck pain but found that conclusive evidence was lacking.8 A need therefore exists to assess the effectiveness of treatments for neck pain by physiotherapists.
Possible ways of dealing with neck pain
Psychosocial factors are known to be important predictors of outcome for neck pain,9 and interventions that deal with the patient's individual concerns, particularly their beliefs and worries, may therefore help to overcome the barriers to recovery. Brief interventions based on a problem solving approach for conditions such as depression have been developed for general practitioners.10 In physiotherapy, two studies have shown that for neck sprain, advice to return to previous activities is useful.11 12 One way to achieve this would be to apply principles of cognitive behaviour therapy to the physiotherapeutic management of neck pain.13 Physiotherapists often give advice about changing lifestyles with an emphasis on posture, in addition to teaching specific exercises.14 They may quite often do this as a one-off session, encouraging the patient to take responsibility for his or her problem. This may be the preferred approach with some patients.
Patients' preferences
Patients' expectations15 or preferences for treatment16 17 may influence outcomes of treatment, and this can be a confounding factor in a trial when it is not possible to blind participants to the treatment they receive. This problem, long recognised, is often dealt with by using a patient preference design.18 Where this is used, only participants who have no preference for treatment are randomised, whereas those who express a preference are allocated to their preferred treatment group. This design, however, does not take us very far.19 Since the design allows patients to select themselves into their treatment groups, any comparisons between the preference groups and the randomised arms could be confounded and therefore unreliable.20
A more robust alternative is to randomise all consenting participants but to elicit preferences before randomisation and use these in the subsequent analysis. This approach allows for a full, unbiased estimate of the effects of preferences on outcomes of treatment. This approach has previously been used successfully in an evaluation of a physiotherapy intervention for back pain.21 We report the results of a fully randomised preference trial of "usual" physiotherapy compared with a brief physiotherapy intervention based on cognitive behaviour principles.
Method
Study population
Recruitment of participants was much slower than expected, and we failed to achieve our original target sample size. We were able to include 268 participants in the trial, 139 were randomised to the brief intervention and 129 to usual physiotherapy. Figure 1 shows their progress through the trial. At 12 months, loss to follow up was similar for both groups (17% for the brief intervention group and 18% for the usual physiotherapy group).
Baseline characteristics and outcomes
Table 2 shows the clinical and demographic characteristics of the two groups. Both groups were evenly balanced in age and quality of life scores. Patients' preferences for usual physiotherapy or the brief intervention were similar in each group, with around 30% having a preference for usual physiotherapy (see table 4).
Table 2 Baseline characteristics of participants included in the study. Values are means (standard deviations) unless indicated otherwise
Table 4 Change in Northwick Park neck pain scores at 12 months by patients' baseline preference
Table 3 shows the mean changes in outcome measures over time, from randomisation to follow up at one year. For our main outcome, the NPQ score, both groups improved at three months; the group receiving usual physiotherapy tended to show greater improvement than the brief intervention group, although this difference did not reach significance. The eight SF-36 domains showed a similar trend favouring the usual physiotherapy group; two of the domains showed significant differences (table 3). At 12 months, although the brief intervention group's change scores (for NPQ) were significantly inferior to those of the group receiving usual physiotherapy, the confidence intervals imply that the effect could be still within the non-inferiority range for the brief intervention (below 1.2 points of the NPQ score). This small differential improvement was also reflected in most of the SF-36 domains, which again favoured usual physiotherapy at a significant level of probability. The small difference in change in the Tampa scores (fear of movement) was significantly in favour of the group receiving the brief intervention at three months (P < 0.004) but not at 12 months (see table 3).
Table 3 Changes in outcome measures at three and 12 months after randomisation
Although the participants were individually randomised, a clustering of outcomes is potentially possible since a single therapist was treating several patients. If these clustering effects were strong then this might alter the results. We therefore used multilevel modelling to check for any clustering effects by undertaking an analysis on the primary outcome. The point estimate remains the same as that in table 4, albeit with a slightly enlarged 95% confidence interval (0.452 to 3.518 v 0.184 to 3.767), which does not affect the conclusion.
None of the patients reported any adverse effects or side effects.
Participants' preference
Table 3 and figure 2 show that participants' preferences for treatment may influence outcome. Figure 3 shows an apparent interaction between participants' preferences and effect. Interestingly, the direction of treatment effect is reversed for those patients who wanted the brief intervention at baseline compared with the patients who were either indifferent or who wanted usual physiotherapy. Those who wanted the brief intervention and got it therefore reported the biggest improvement on the NPQ scores, albeit a small and non-statistically significant difference.
Fig 2 Influence of patients' preferences on outcomes of treatment shown as mean change in scores on the Northwick Park neck pain questionnaire with 95% confidence intervals (negative scores indicate improvement)
Fig 3 Interaction between pre-randomised preferences and treatment allocation (negative scores indicate improved scores on the Northwick Park neck pain questionnaire)
In the "indifferent" group, the effects of patients' preferences are not present, and this analysis shows an advantage of being assigned to usual physiotherapy. For patients with a preference for usual physiotherapy, the overall effect of that treatment did not seem to be enhanced. However, those preferring usual physiotherapy but allocated to the brief intervention reported more pain according to their NPQ scores at 12 months. A formal statistical test of these interactions did not reach significance (P = 0.19), but we note that the trial was not balanced to test interaction formally and the interaction tests have relatively low power.
To assess whether preference affected our main results, we included a preference term in a further analysis of the NPQ scores. Including only the preference main effect term hardly changed the original result. However, adding a preference interaction term in the analysis produced a smaller estimated difference of 1.58 (95% confidence interval -0.13 to 3.29) between the treatments at 12 months (P = 0.07), in contrast to the main analysis for 12 months shown in table 3.
Discussion
Hackett G, Bundred P, Hutton J, O'Brien J, Stanley I. Management of joint and soft tissue injuries in three general practices: value of on-site physiotherapy. Br J Gen Pract 1993;43: 61-4.
Bovim G, Schrader H, Sand T. Neck pain in the general population. Spine 1994;19: 1307-9.
Cote P, Cassidy J, Carroll L. The Saskatchewan health and back pain survey. The prevalence of neck pain and related disability in Saskatchewan adults. Spine 1998;23: 1689-98.
Borghouts J, Koes B, Vondeling H, Bouter L. Cost-of-illness of neck pain in the Netherlands. Pain 1999;80: 629-36.
Foster N, Thompson K, Baxter G, Allen J. Management of non-specific low back pain by physiotherapists in Britain and Ireland. Spine 1999;24: 1332-42.
Battie M, Cherkin D, Dunn D, Ciol M, Wheeler K. Managing low back pain: attitudes and treatment preferences of physical therapists. Phys Ther 1994;74: 219-226.
Gross A, Aker P, Goldsmith C, Peloso P. Physical medicine modalities for mechanical neck disorders: Cochrane Database Syst Rev 2000(2): CD000961.
Hoving J, Gross A, Gasner D, Kay T, Kennedy C, Hondras M, et al. A critical appraisal of review articles on the effectiveness of conservative treatment for neck pain. Spine 2001;26: 196-205.
Croft P, Lewis M, Papageorgiou A, Thomas E, Jayson M, Macfarlane G, et al. Risk factors for neck pain: a longitudinal study in the general population. Pain 2001;93: 317-25.
Mynors-Wallis L, Gath D, Lloyd-Thomas A, Tomlinson D. Randomised controlled trial comparing problem solving treatment with amitriptyline and placebo for major depression in primary care. BMJ 1995;310: 441-5.
McKinney L. Early mobilisation and outcome in acute sprains of the neck. BMJ 1989;299: 1006-8.
Borchgrevink G, Kaasa A, McDonagh D, Stiles T, Haraldseth O, Lereim I. Acute treatment of whiplash neck sprain injuries: a randomised trial of treatment during the first 14 days after a car accident. Spine 1998;23: 25-31.
Foster N, Pincus T, Underwood M, Vogel S, Breen A, Harding G. Understanding the process of care for musculoskeletal conditions—why a biomedical approach is inadequate. Rheumatology 2003;42: 401-3.
Sluijs E, Knibbe J. Patient compliance with exercise: different theoretical approaches to short-term and long-term compliance. Patient Educ Counseling 1991;17: 191-204.
Metcalfe C. An investigation of patients' expectations of outpatient physiotherapy for peripheral musculoskeletal conditions and their effect on treatment outcome . Hull: University of Hull, 2003.
Torgerson D, Klaber-Moffett J, Russell I. Patient preferences in randomised trials: threat or opportunity? J Health Serv Res Pol 1996;1: 194-7.
Torgerson D, Sibbald B. Understanding controlled trials. What is a patient preference trial? BMJ 1998;316: 360.
Brewin C, Bradley C. Patient preferences and randomised clinical trials. BMJ 1989;299: 313-315.
McPherson K, Chalmers I. Incorporating patient preferences into clinical trials. BMJ 1998;317: 78.
Dunn G. The challenge of patient choice and non-adherence to treatment in randomized controlled trials of counseling or psychotherapy. Understand Stat 2002;1: 19-29.
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.
Walker L. Communication skills: when not if to teach. Eur J Cancer 1996;32A: 1457-9.
Leake A, Cooper J, Dyer S, Williams K, Turner-Stokes L, Frank A. The Northwick Park neck pain questionnaire, devised to measure neck pain and disability. Br J Rheumatol 1994;33: 469-474.
Ruta A, Ruta D, Abdalla M, Russell I. SF36 health survey questionnaire: II Responsiveness to changes in health status in four common clinical conditions. Qual Health Care 1994;3: 186-92.
Kori S, Miller R, Todd D. Kinesophobia: a new view of chronic pain behaviour. Pain Manage 1990;January: 35-43.(Jennifer A Klaber Moffett, deputy direct)
Correspondence to: J K Moffett j.k.moffett@hull.ac.uk
Abstract
Neck pain accounts for 15% of all soft tissue problems seen in general practice1 and is a common reason for referral for physiotherapy treatment. In any one year, 30% of adults will report neck pain, and 5-10% will be disabled with it.2 3 Although neck pain has been regarded as self limiting and benign, it consumes a substantial proportion of healthcare resources.4 A recent survey of 10 community physiotherapy departments in the east Yorkshire area has shown that of 7899 subjects referred, 1060 (13.4%) had neck complaints. Most physiotherapists in the United Kingdom provide between four and 10 treatment sessions for spinal problems such as back pain,5 whereas in the United States they provide between nine and 12 treatment sessions.6 Little evidence is available, however, with respect to the effectiveness and cost effectiveness of routinely used physiotherapy interventions for neck pain.7 A criteria based appraisal of review articles reported finding 12 systematic reviews on the management of neck pain but found that conclusive evidence was lacking.8 A need therefore exists to assess the effectiveness of treatments for neck pain by physiotherapists.
Possible ways of dealing with neck pain
Psychosocial factors are known to be important predictors of outcome for neck pain,9 and interventions that deal with the patient's individual concerns, particularly their beliefs and worries, may therefore help to overcome the barriers to recovery. Brief interventions based on a problem solving approach for conditions such as depression have been developed for general practitioners.10 In physiotherapy, two studies have shown that for neck sprain, advice to return to previous activities is useful.11 12 One way to achieve this would be to apply principles of cognitive behaviour therapy to the physiotherapeutic management of neck pain.13 Physiotherapists often give advice about changing lifestyles with an emphasis on posture, in addition to teaching specific exercises.14 They may quite often do this as a one-off session, encouraging the patient to take responsibility for his or her problem. This may be the preferred approach with some patients.
Patients' preferences
Patients' expectations15 or preferences for treatment16 17 may influence outcomes of treatment, and this can be a confounding factor in a trial when it is not possible to blind participants to the treatment they receive. This problem, long recognised, is often dealt with by using a patient preference design.18 Where this is used, only participants who have no preference for treatment are randomised, whereas those who express a preference are allocated to their preferred treatment group. This design, however, does not take us very far.19 Since the design allows patients to select themselves into their treatment groups, any comparisons between the preference groups and the randomised arms could be confounded and therefore unreliable.20
A more robust alternative is to randomise all consenting participants but to elicit preferences before randomisation and use these in the subsequent analysis. This approach allows for a full, unbiased estimate of the effects of preferences on outcomes of treatment. This approach has previously been used successfully in an evaluation of a physiotherapy intervention for back pain.21 We report the results of a fully randomised preference trial of "usual" physiotherapy compared with a brief physiotherapy intervention based on cognitive behaviour principles.
Method
Study population
Recruitment of participants was much slower than expected, and we failed to achieve our original target sample size. We were able to include 268 participants in the trial, 139 were randomised to the brief intervention and 129 to usual physiotherapy. Figure 1 shows their progress through the trial. At 12 months, loss to follow up was similar for both groups (17% for the brief intervention group and 18% for the usual physiotherapy group).
Baseline characteristics and outcomes
Table 2 shows the clinical and demographic characteristics of the two groups. Both groups were evenly balanced in age and quality of life scores. Patients' preferences for usual physiotherapy or the brief intervention were similar in each group, with around 30% having a preference for usual physiotherapy (see table 4).
Table 2 Baseline characteristics of participants included in the study. Values are means (standard deviations) unless indicated otherwise
Table 4 Change in Northwick Park neck pain scores at 12 months by patients' baseline preference
Table 3 shows the mean changes in outcome measures over time, from randomisation to follow up at one year. For our main outcome, the NPQ score, both groups improved at three months; the group receiving usual physiotherapy tended to show greater improvement than the brief intervention group, although this difference did not reach significance. The eight SF-36 domains showed a similar trend favouring the usual physiotherapy group; two of the domains showed significant differences (table 3). At 12 months, although the brief intervention group's change scores (for NPQ) were significantly inferior to those of the group receiving usual physiotherapy, the confidence intervals imply that the effect could be still within the non-inferiority range for the brief intervention (below 1.2 points of the NPQ score). This small differential improvement was also reflected in most of the SF-36 domains, which again favoured usual physiotherapy at a significant level of probability. The small difference in change in the Tampa scores (fear of movement) was significantly in favour of the group receiving the brief intervention at three months (P < 0.004) but not at 12 months (see table 3).
Table 3 Changes in outcome measures at three and 12 months after randomisation
Although the participants were individually randomised, a clustering of outcomes is potentially possible since a single therapist was treating several patients. If these clustering effects were strong then this might alter the results. We therefore used multilevel modelling to check for any clustering effects by undertaking an analysis on the primary outcome. The point estimate remains the same as that in table 4, albeit with a slightly enlarged 95% confidence interval (0.452 to 3.518 v 0.184 to 3.767), which does not affect the conclusion.
None of the patients reported any adverse effects or side effects.
Participants' preference
Table 3 and figure 2 show that participants' preferences for treatment may influence outcome. Figure 3 shows an apparent interaction between participants' preferences and effect. Interestingly, the direction of treatment effect is reversed for those patients who wanted the brief intervention at baseline compared with the patients who were either indifferent or who wanted usual physiotherapy. Those who wanted the brief intervention and got it therefore reported the biggest improvement on the NPQ scores, albeit a small and non-statistically significant difference.
Fig 2 Influence of patients' preferences on outcomes of treatment shown as mean change in scores on the Northwick Park neck pain questionnaire with 95% confidence intervals (negative scores indicate improvement)
Fig 3 Interaction between pre-randomised preferences and treatment allocation (negative scores indicate improved scores on the Northwick Park neck pain questionnaire)
In the "indifferent" group, the effects of patients' preferences are not present, and this analysis shows an advantage of being assigned to usual physiotherapy. For patients with a preference for usual physiotherapy, the overall effect of that treatment did not seem to be enhanced. However, those preferring usual physiotherapy but allocated to the brief intervention reported more pain according to their NPQ scores at 12 months. A formal statistical test of these interactions did not reach significance (P = 0.19), but we note that the trial was not balanced to test interaction formally and the interaction tests have relatively low power.
To assess whether preference affected our main results, we included a preference term in a further analysis of the NPQ scores. Including only the preference main effect term hardly changed the original result. However, adding a preference interaction term in the analysis produced a smaller estimated difference of 1.58 (95% confidence interval -0.13 to 3.29) between the treatments at 12 months (P = 0.07), in contrast to the main analysis for 12 months shown in table 3.
Discussion
Hackett G, Bundred P, Hutton J, O'Brien J, Stanley I. Management of joint and soft tissue injuries in three general practices: value of on-site physiotherapy. Br J Gen Pract 1993;43: 61-4.
Bovim G, Schrader H, Sand T. Neck pain in the general population. Spine 1994;19: 1307-9.
Cote P, Cassidy J, Carroll L. The Saskatchewan health and back pain survey. The prevalence of neck pain and related disability in Saskatchewan adults. Spine 1998;23: 1689-98.
Borghouts J, Koes B, Vondeling H, Bouter L. Cost-of-illness of neck pain in the Netherlands. Pain 1999;80: 629-36.
Foster N, Thompson K, Baxter G, Allen J. Management of non-specific low back pain by physiotherapists in Britain and Ireland. Spine 1999;24: 1332-42.
Battie M, Cherkin D, Dunn D, Ciol M, Wheeler K. Managing low back pain: attitudes and treatment preferences of physical therapists. Phys Ther 1994;74: 219-226.
Gross A, Aker P, Goldsmith C, Peloso P. Physical medicine modalities for mechanical neck disorders: Cochrane Database Syst Rev 2000(2): CD000961.
Hoving J, Gross A, Gasner D, Kay T, Kennedy C, Hondras M, et al. A critical appraisal of review articles on the effectiveness of conservative treatment for neck pain. Spine 2001;26: 196-205.
Croft P, Lewis M, Papageorgiou A, Thomas E, Jayson M, Macfarlane G, et al. Risk factors for neck pain: a longitudinal study in the general population. Pain 2001;93: 317-25.
Mynors-Wallis L, Gath D, Lloyd-Thomas A, Tomlinson D. Randomised controlled trial comparing problem solving treatment with amitriptyline and placebo for major depression in primary care. BMJ 1995;310: 441-5.
McKinney L. Early mobilisation and outcome in acute sprains of the neck. BMJ 1989;299: 1006-8.
Borchgrevink G, Kaasa A, McDonagh D, Stiles T, Haraldseth O, Lereim I. Acute treatment of whiplash neck sprain injuries: a randomised trial of treatment during the first 14 days after a car accident. Spine 1998;23: 25-31.
Foster N, Pincus T, Underwood M, Vogel S, Breen A, Harding G. Understanding the process of care for musculoskeletal conditions—why a biomedical approach is inadequate. Rheumatology 2003;42: 401-3.
Sluijs E, Knibbe J. Patient compliance with exercise: different theoretical approaches to short-term and long-term compliance. Patient Educ Counseling 1991;17: 191-204.
Metcalfe C. An investigation of patients' expectations of outpatient physiotherapy for peripheral musculoskeletal conditions and their effect on treatment outcome . Hull: University of Hull, 2003.
Torgerson D, Klaber-Moffett J, Russell I. Patient preferences in randomised trials: threat or opportunity? J Health Serv Res Pol 1996;1: 194-7.
Torgerson D, Sibbald B. Understanding controlled trials. What is a patient preference trial? BMJ 1998;316: 360.
Brewin C, Bradley C. Patient preferences and randomised clinical trials. BMJ 1989;299: 313-315.
McPherson K, Chalmers I. Incorporating patient preferences into clinical trials. BMJ 1998;317: 78.
Dunn G. The challenge of patient choice and non-adherence to treatment in randomized controlled trials of counseling or psychotherapy. Understand Stat 2002;1: 19-29.
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.
Walker L. Communication skills: when not if to teach. Eur J Cancer 1996;32A: 1457-9.
Leake A, Cooper J, Dyer S, Williams K, Turner-Stokes L, Frank A. The Northwick Park neck pain questionnaire, devised to measure neck pain and disability. Br J Rheumatol 1994;33: 469-474.
Ruta A, Ruta D, Abdalla M, Russell I. SF36 health survey questionnaire: II Responsiveness to changes in health status in four common clinical conditions. Qual Health Care 1994;3: 186-92.
Kori S, Miller R, Todd D. Kinesophobia: a new view of chronic pain behaviour. Pain Manage 1990;January: 35-43.(Jennifer A Klaber Moffett, deputy direct)