Helen Frost

Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial

Abstract Objectives To assess the clinical effectiveness of surgical stabilisation (spinal fusion) compared with intensive rehabilitation for patients with chronic low back pain. Design Multicentre randomised controlled trial. Setting 15 secondary care orthopaedic and rehabilitation centres across the United Kingdom. Participants 349 participants aged 18-55 with chronic low back pain of at least one years duration who were considered candidates for spinal fusion. Intervention Lumbar spine fusion or an intensive rehabilitation programme based on principles of cognitive behaviour therapy. Main outcome measure The primary outcomes were the Oswestry disability index and the shuttle walking test measured at baseline and two years after randomisation. The SF-36 instrument was used as a secondary outcome measure. Results 176 participants were assigned to surgery and 173 to rehabilitation. 284 (81%) provided follow-up data at 24 months. The mean Oswestry disability index changed favourably from 46.5 (SD 14.6) to 34.0 (SD 21.1) in the surgery group and from 44.8 (SD14.8) to 36.1 (SD 20.6) in the rehabilitation group. The estimated mean difference between the groups was –4.1 (95% confidence interval –8.1 to –0.1, P = 0.045) in favour of surgery. No significant differences between the treatment groups were observed in the shuttle walking test or any of the other outcome measures. Conclusions Both groups reported reductions in disability during two years of follow-up, possibly unrelated to the interventions. The statistical difference between treatment groups in one of the two primary outcome measures was marginal and only just reached the predefined minimal clinical difference, and the potential risk and additional cost of surgery also need to be considered. No clear evidence emerged that primary spinal fusion surgery was any more beneficial than intensive rehabilitation.

A fitness programme for patients with chronic low back pain: 2-year follow-up of a randomised controlled trial.

&NA; The aim of this study was to assess the long‐term effect of a supervised fitness programme on patients with chronic low back pain. The design of the study was a single blind randomised controlled trial with follow‐up, by postal questionnaire, 2 years after intervention. The Oswestry Low Back Pain Disability Index was used as the outcome measure to assess daily activity affected by back pain. Eighty‐one patients with chronic low back pain, who were referred to the physiotherapy department of a National Health Service orthopaedic hospital, were randomised to either a supervised fitness programme or a control group. Patients in the intervention group and control group were taught specific exercises to be continued at home and referred to a backschool for back care education. In addition, the intervention group attended eight sessions of a supervised fitness programme. Sixty‐two patients (76%) with a mean age of 37 years, returned the Oswestry Low Back Pain Disability Index questionnaire. Of these, 29 were in the intervention group and 31 in the control group. Patients in the intervention group demonstrated a mean reduction of 7.7% in the Oswestry Low Back Pain Disability Index score (95% confidence interval of mean paired difference 3.9, 11.6 P<0.001), compared with only 2.4% in the control group (95% confidence interval of mean paired difference −2.0, 6.9 P>0.05). Between group comparisons demonstrated a statistically significant difference in disability scores between the treatment and control group (mean difference 5.8, 95% confidence interval 0.3, 11.4 P<0.04). This study supports the current trend towards a more active treatment approach to low back pain. We have demonstrated clinical effectiveness of a fitness programme 2 years after treatment but this needs to be replicated in a larger study which should include a cost effectiveness analysis, further analysis of objective functional status and a placebo intervention group.

Surgical stabilisation of the spine compared with a programme of intensive rehabilitation for the management of patients with chronic low back pain: cost utility analysis based on a randomised controlled trial.

Abstract Objective To determine whether, from a health provider and patient perspective, surgical stabilisation of the spine is cost effective when compared with an intensive programme of rehabilitation in patients with chronic low back pain. Design Economic evaluation alongside a pragmatic randomised controlled trial. Setting Secondary care. Participants 349 patients randomised to surgery (n = 176) or to an intensive rehabilitation programme (n = 173) from 15 centres across the United Kingdom between June 1996 and February 2002. Main outcome measures Costs related to back pain and incurred by the NHS and patients up to 24 months after randomisation. Return to paid employment and total hours worked. Patient utility as estimated by using the EuroQol EQ-5D questionnaire at several time points and used to calculate quality adjusted life years (QALYs). Cost effectiveness was expressed as an incremental cost per QALY. Results At two years, 38 patients randomised to rehabilitation had received rehabilitation and surgery whereas just seven surgery patients had received both treatments. The mean total cost per patient was estimated to be £7830 (SD £5202) in the surgery group and £4526 (SD £4155) in the intensive rehabilitation arm, a significant difference of £3304 (95% confidence interval £2317 to £4291). Mean QALYs over the trial period were 1.004 (SD 0.405) in the surgery group and 0.936 (SD 0.431) in the intensive rehabilitation group, giving a non-significant difference of 0.068 (–0.020 to 0.156). The incremental cost effectiveness ratio was estimated to be £48 588 per QALY gained (–£279 883 to £372 406). Conclusion Two year follow-up data show that surgical stabilisation of the spine may not be a cost effective use of scarce healthcare resources. However, sensitivity analyses show that this could change—for example, if the proportion of rehabilitation patients requiring subsequent surgery continues to increase.

A randomized controlled trial of exercise to improve mobility and function after elective knee arthroplasty. Feasibility, results and methodological difficulties

Objective: To assess the feasibility of comparing two types of exercise regime aiming to improve mobility and function following knee arthroplasty. Design: A single-blind randomized controlled trial. Subjects: Patients with primary, unilateral knee osteoarthritis undergoing elective knee joint replacement. Intervention: Home-based traditional exercise group (TEG) or home-based functional exercise group (FEG) following discharge from hospital. Outcome measures: These included goniometry; a knee-specific pain score, leg extensor power and a walking test. Patients were followed up at three, six and 12 months after surgery. Results: Forty-seven patients met the study criteria, 24 were randomized to the TEG and 23 to the FEG. There were marked improvements in mobility, leg extensor power and pain in the year after surgery (MANOVA p < 0.001). There were no statistically significant differences between the two exercise groups. Knee flexion decreased during the follow-up period and had not recovered by 12 months. Retention of patients was a problem, with nearly 50% lost to follow-up at 12 months. These patients were assessed as having low motivation during inpatient rehabilitation (p < 0.05). Conclusions: There were trends in favour of the FEG that were of clinical relevance. A definitive study would need a sample size of at least 100 patients in each arm. It is essential to develop strategies to combat loss to follow-up.

Responsiveness of a Patient Specific Outcome Measure Compared With the Oswestry Disability Index v2.1 and Roland and Morris Disability Questionnaire for Patients With Subacute and Chronic Low Back Pain

Study Design. A prospective cohort. Objective. The aim of this study was to compare the responsiveness of a patient specific outcome measure with the Oswestry Disability Index v2.1 (ODI) and the Roland and Morris Disability Questionnaire (RMDQ) for patients with mild to moderate subacute and chronic low back pain. Summary of Background Data. Patient specific outcome measures allow individuals to select and rate the relative importance of activities they consider of greatest relevance. However, there is a paucity of research reporting the responsiveness of these measures for patient with back pain. Methods. Two hundred and one patients were assessed at baseline and 12 months using the patient specific activity questionnaire (PSAQ), the ODI, the RMDQ, and a transition rating scale. The latter was used to categorize patients into 3 groups (better, same or worse). Effect size statistics, receiver operating characteristic curves and 1-way between groups analysis of variance were used in the analysis. Results. All instruments were able to detect improvements in back pain as measured by the transition rating scale. In this improved group effect sizes were large for the PSAQ (1.08 to 1.31) and ODI (−0.88 to −1.00) but only moderate for the RMDQ (−0.70 to −0.74). In the deteriorated group effect sizes were moderate to large for the ODI (0.61 to 1.16) and RMDQ (0.69 to 1.25), but small for the PSAQ (−0.16 to −0.26). The areas under receiver operator characteristic curves for the ODI, PSAQ, and RMDQ, respectively were: 0.75 (95% CI 0.68 to 0.82), 0.75 (95% CI 0.68 to 0.82) and 0.69 (95% CI 0.61 to 0.76). Conclusion. The PSAQ was highly responsive to change in patients who report improvement in back symptoms but unlike the ODI and RMDQ was unable to detect deterioration. Overall, the ODI was more responsive than either the PSAQ or the RMDQ.

A placebo controlled double blind trial to evaluate the effectiveness of pulsed short wave therapy for osteoarthritic hip and knee pain

&NA; The aim of this study was to investigate the effectiveness of pulsed short wave (PSW) in the relief of pain in osteoarthritis of the hip and knee. Ninety‐two patients, mean age 63 years, (34 men and 58 women) were randomly allocated to one of three groups: (1) Active PSW, using the dosage found in a pilot study to be non‐significantly most effective, (2) Placebo PSW, (3) No treatment control group. Nine sessions of treatment were provided over a 3‐week period, each application lasting for 15 min. The machine was modified by the manufacturers so that the therapist was able to administer the treatment and carry out assessments without being aware of the treatment allocation. Outcome measures included sensory and affective pain diary reports averaged over days and weeks, self‐reported benefit and the General Health Questionnaire. Analysis of variance with repeated measures over time was used to find out if the active treatment had a specific effect, incremental to the placebo effect. There were no significant differences between the active and placebo groups over time. According to the pain diary reports, both active and placebo groups tended to improve slightly during treatment, but worsened after its withdrawal. Patients who were given the placebo application tended to report more benefit than those who had the active treatment, although this did not quite reach statistical significance (P < 0.06). Patients who were not on a waiting list for surgery did significantly better over time than those who were (P < 0.03). There were no significant differences between the groups over time for the other outcome variables. Any treatment effect on this patient population appears to have been largely placebo‐mediated. No evidence was found therefore for the specific effectiveness of PSW for treatment of osteoarthritic hip or knee pain.

Cost-utility analysis of physiotherapy treatment compared with physiotherapy advice in low back pain.

Study Design. Economic evaluation alongside a pragmatic multicenter randomized controlled trial from the National Health Service (NHS) and societal perspective. Objective. To perform a cost-utility analysis of routine physiotherapy treatment compared with an assessment session and advice from a physiotherapist for patients with subacute and chronic low back pain. Summary of Background Data. Lack of evidence for some types of physiotherapy intervention and a paucity of cost-effectiveness data for treatment of low back pain has led to controversy and uncertainty within the medical and allied professions. Patients and Methods. A total of 286 patients with low back pain of more than a 6-week duration were randomized to physiotherapy treatment or advice on remaining active from a physiotherapist. Data were collected on back pain-related NHS and patients’ costs over a 12-month post randomization period. The primary outcome measure was the Oswestry Disability Index at 12 months, with additional Oswestry Disability Index measures at 2 and 6 months. The EuroQol EQ-5D was used to calculate quality adjusted life years. Cost-effectiveness was expressed as the incremental cost per quality adjusted life year gained. Uncertainty was handled using confidence ellipses for the ratio and cost-effectiveness acceptability curves. Results. The total NHS costs were not significantly different at £179 (£221) for physiotherapy and £159 (£260) for the advice group. However, patients in the physiotherapy group had significantly higher out-of-pocket health care expenditure (£40, 95% confidence interval £9 to £71). Utility levels improved in both groups from baseline to 12 months, with no significant differences between groups. Conclusions. The results indicate no significant differences in either NHS costs or effects. However, the significantly higher out-of-pocket expenses incurred by patients receiving routine physiotherapy suggests that advice given by a physiotherapist should be considered as the first-line treatment for patients with this level of back pain disability.

Recovery of Mobility After Knee Arthroplasty Expected Rates and Influencing Factors

Mobility was measured in 79 people 6 months after knee arthroplasty using timed tests of stair climbing and walking speed. Recovery rates were calculated in comparison with a preoperative assessment. Changes in leg extensor power, knee flexion range, and pain were tracked simultaneously. Stair climbing speed improved on average by 53% during the first 6 months, and walking speed by 45%. In multivariate models, 2 preoperative factors emerged as being influential on recovery of mobility: leg extensor power and body mass index. A marked loss of flexion in the postoperative period was not a significant determinant of mobility speed. At 6 months, body mass index was the most significant determinant of stair speed, and leg extensor power was the most significant determinant of walking speed.

Responsiveness of objective, disease-specific, and generic outcome measures in patients with chronic low back pain: an assessment for improving, stable, and deteriorating patients.

Study Design. Analysis of outcome data collected prospectively from 250 patients recruited to the UK Spine Stabilization Trial. Objectives. To compare the responsiveness of the Shuttle Walking Test (SWT), which is an objective outcome measure, with that of a disease-specific (the Oswestry Disability Index) and 2 generic (the EQ-5D and SF-36) instruments in patients with chronic low back pain (LBP). Summary of Background Data. Studies assessing the performance of subjective disease-specific and generic measures have increased in recent years, although there is a paucity of research reporting the responsiveness of objective measures in patients with LBP. The focus of investigation has been on responsiveness to improvements in LBP symptoms. For patients with deteriorating health, it remains largely unclear how outcome instruments perform. Methods. Baseline and 12-month outcome data collected on 250 patients with chronic LBP recruited to the Spine Stabilization Trial were analyzed using traditional measures of responsiveness. Analyses were performed for 3 groups of patients: those who rated their health status as improved, deteriorated, and stable at 12 months. Results. The SWT was shown by all measures to be responsive to health improvement, although less so than other instruments. All instruments were able to detect small-to-moderate reductions in health. Instrument floor effects may be responsible for small SF-36 change scores recorded for deteriorating patients. Conclusions. Although shown to be responsive, including the SWT alongside disease-specific and generic instruments is unlikely to add additional information. All instruments appear responsive to patient deterioration, however, further research for the SF-36 is required.

A Functional Restoration Programme for Chronic Low Back Pain

Summary The purpose of this longitudinal prospective study was to assess the clinical benefits of a newly established functional restoration programme for patients with chronic low back pain. The overall aim of the programme was to improve function and encourage patients to take a more active role in their own management. One hundred and twenty-nine patients with chronic low back pain attended an outpatient functional restoration programme between February 1994 and March 1997. They were assessed using a battery of functional and psychological outcome measures before treatment, immediately after treatment, and at 7, 15, 27 and 55 weeks after inclusion. There was a high prevalence of psychological distress prior to treatment. At 55 weeks after treatment, effect size scores for measures of disability, psychological distress and depression were small to moderate (Oswestry Low Back Pain Disability index 0.23, General Health Questionnaire 0.46, Zung depression 0.47, pain self-efficacy 0.6); and scores for walking distance were large (1.2). To date, the effectiveness of functional restoration programmes has not been properly assessed in the United Kingdom, and although the results of this study seem positive enough to justify the programme, randomised controlled trials are necessary to assess clinical and cost effectiveness.