STUDY DESIGN: An economic evaluation alongside a randomized controlled trial comparing behavioral graded activity (BGA) with manual therapy (MT).
OBJECTIVE: To evaluate the cost-effectiveness of BGA in comparison with MT for patients with subacute neck pain from a societal perspective.
SUMMARY OF BACKGROUND DATA: Neck pain is common and poses an important socioeconomic burden to society. Data on the cost-effectiveness of treatments for neck pain are scarce.
METHODS: A randomized clinical trial was conducted, involving 146 patients with subacute nonspecific neck pain. The BGA program can be described as a time-contingent increase in activities from baseline toward predetermined goals. MT consists of specific spinal mobilization techniques and exercises. Clinical outcomes included recovery, pain, disability, and quality-adjusted life-years (QALYs). Costs were measured from a societal perspective using cost diaries. The follow-up period was 52 weeks. Multiple imputation was used for missing cost and effect data. Uncertainty surrounding cost differences and incremental cost-effectiveness ratios was estimated using bootstrapping. Cost-effectiveness planes and cost-effectiveness acceptability (CEA) curves were estimated.
RESULTS: BGA had no significant effect on recovery or QALYs gained in comparison with MT but pain and disability did improve significantly in the BGA group in comparison with the MT group. Total societal costs in the BGA group were nonsignificantly higher than in the MT group. Cost-effectiveness analyses showed that BGA is not cost-effective in comparison with MT for recovery and QALYs gained. Substantial investments are needed to reach a 0.95 probability that BGA is cost-effective in comparison with MT for pain and disability.
CONCLUSION: On the basis of the data presented, we consider BGA not cost-effective in comparison with MT.
<b>BACKGROUND: </b>Shoulder complaints are common in primary care and have unfavourable long term prognosis. Our objective was to evaluate the clinical effectiveness of manipulative therapy of the cervicothoracic spine and the adjacent ribs in addition to usual medical care (UMC) by the general practitioner in the treatment of shoulder complaints.<b>METHODS: </b>This economic evaluation was conducted alongside a randomized trial in primary care. Included were 150 patients with shoulder complaints and a dysfunction of the cervicothoracic spine and adjacent ribs. Patients were treated with UMC (NSAID's, corticosteroid injection or referral to physical therapy) and were allocated at random (yes/no) to manipulative therapy (manipulation and mobilization). Patient perceived recovery, severity of main complaint, shoulder pain, disability and general health were outcome measures. Data about direct and indirect costs were collected by means of a cost diary.<b>RESULTS: </b>Manipulative therapy as add-on to UMC accelerated recovery on all outcome measures included. At 26 weeks after randomization, both groups reported similar recovery rates (41% vs. 38%), but the difference between groups in improvement of severity of the main complaint, shoulder pain and disability sustained. Compared to the UMC group the total costs were higher in the manipulative group (€1167 vs. €555). This is explained mainly by the costs of the manipulative therapy itself and the higher costs due sick leave from work. The cost effectiveness ratio showed that additional manipulative treatment is more costly but also more effective than UMC alone. The cost-effectiveness acceptability curve shows that a 50%-probability of recovery with AMT within 6 months after initiation of treatment is achieved at €2876.<b>CONCLUSION: </b>Manipulative therapy in addition to UMC accelerates recovery and is more effective than UMC alone on the long term, but is associated with higher costs. INTERNATIONAL STANDARD RANDOMIZED CONTROLLED TRIAL NUMBER REGISTER: ISRCTN11216.
STUDY DESIGN: A randomized clinical trial. OBJECTIVE: To compare the effectiveness of a behavioral graded activity program with manual therapy in patients with subacute (4-12 weeks) nonspecific neck pain. SUMMARY OF BACKGROUND DATA: Neck pain is a common complaint, for which many conservative therapies are available in primary care. There is strong evidence for manual therapy in combination with exercises. Psychosocial factors are also believed to play a role in chronic pain. The evidence of the effectiveness of a program focused on these factors is still unknown. METHODS: A randomized clinical trial was conducted, involving 146 patients with subacute nonspecific neck pain. The BGA program can be described as a time-contingent increase in activities from baseline toward predetermined goals. Manual therapy consists of specific spinal mobilization techniques and exercises. Primary outcomes were global perceived effect, the Numerical Rating Scale for pain and the Neck Disability Index. Secondary outcomes were the Tampa Scale for Kinesiophobia, the 4 Dimensional Symptom Questionnaire, and the Pain Coping and Cognition List. Measurements were carried out at baseline and 6, 13, 26, and 52 weeks after randomization. Data are analyzed according to the intention-to-treat principle, using multilevel analysis. RESULTS: The success rates at 52 weeks, based on the GPE were 89.4% for the BGA program and 86.5% for MT. This difference was not statistically significant. For pain and disability, a difference was found in favor of the BGA program; mean difference for pain = 0.99 (95% CI 0.15-1.83) and mean difference for NDI = 2.42 (95% CI 0.52-4.32). All other differences between the interventions in the primary and secondary outcomes were not statistically significant. CONCLUSION: Based on this trial it can be concluded that there are only marginal, but not clinically relevant, differences between a BGA program and MT.
Objective The purpose of this study was to examine the effect of manipulative therapy on the shoulder girdle, in addition to usual care provided by the general practitioner, on the outcomes of physical examination tests for the treatment of shoulder complaints. Methods This was a randomized controlled trial in a primary care setting in the Netherlands. A total of 150 participants were recruited from December 2000 until December 2002. All patients received usual care by the general practitioner. Usual care included one or more of the following depending on the needs of the patient: information/advice, oral analgesics or nonsteroidal antiinflammatory drugs, corticosteroid injections, exercises, and massage. In addition to usual care, the intervention group received manipulative therapy, up to 6 treatment sessions in a 12-week period. Twenty-four physical examination tests were done at baseline and after 6, 12, and 26 weeks. Factor analysis was done to reduce the number of outcome measures. Results The factor analysis resulted in 4 factors: 'shoulder pain,' 'neck pain,' 'shoulder mobility,' and 'neck mobility.' At 6 weeks, no significant differences between groups were found. At 12 weeks, the mean changes of all 4 factors favored the intervention group; the factors 'shoulder pain' and 'neck pain' reached statistical significance (95% confidence interval [CI], 0.1-2.1). At 26 weeks, differences in the factors 'shoulder pain' (95% CI, 0.0-2.6), 'shoulder mobility' (95% CI, 0.2-1.7), and 'mobility neck' (95% CI, 0.2-1.3) statistically favored the intervention group. Conclusion In this pragmatic study, manipulative therapy, in addition to usual care by the general practitioner, diminished severity of shoulder pain and neck pain and improved shoulder and neck mobility.
OBJECTIVE: The primary aim of this study was to determine the effectiveness and cost-effectiveness of adding manual therapy to a physiotherapy programme for ankle fracture.
DESIGN: Assessor-blinded randomized controlled trial.
PARTICIPANTS: Ninety-four adults were recruited within one week of cast removal for isolated ankle fracture. Inclusion criteria were: they were able to weight-bear as tolerated or partial weight-bear, were referred for physiotherapy, and experienced pain. Ninety-one participants completed the study.
METHODS: Participants were randomly allocated to receive manual therapy (anterior-posterior joint mobilization over the talus) plus a standard physiotherapy programme (experimental), or the standard physiotherapy programme only (control). They were assessed by a blinded assessor at baseline, and at 4, 12 and 24 weeks. The main outcomes were activity limitation and quality of life. Information on costs and healthcare utilization was collected every 4 weeks up to 24 weeks.
RESULTS: There were no clinically worthwhile differences in activity limitation or quality of life between groups at any time-point. There was also no between-group difference in quality-adjusted life-years, but the experimental group incurred higher out-of-pocket costs (mean between-group difference = AU$200, 95% confidence interval 26-432).
CONCLUSION: When provided in addition to a physiotherapy programme, manual therapy did not enhance outcome in adults after ankle fracture.
OBJECTIVES: Cost-effectiveness and cost-utility analyses were conducted to compare advice and exercise plus manual therapy (MT) and advice and exercise plus pulsed shortwave diathermy (PSWD) with advice and exercise alone (A&E) in the treatment of non-specific neck disorders by experienced physiotherapists.
METHODS: Between July 2000 and June 2002, 350 participants with neck disorders from 15 physiotherapy departments were randomized to: A&E (n = 115); MT (n = 114) and PSWD (n = 121). Outcome and resource-use data were collected using physiotherapist case report forms and participant self-complete questionnaires. Outcome measures were the Northwick Park Neck Pain Questionnaire (NPQ) and EuroQoL EQ-5D [used to derive quality-adjusted-life-year (QALY) utility scores]. Two economic viewpoints were considered (health care and societal). Cost-effectiveness acceptability curves were used to assess the probabilities of the interventions being cost-effective at different willingness-to-pay threshold values.
RESULTS: Mean improvement in NPQ at 6 months was 11.5 in the A&E group, 10.2 in the MT group and 10.3 in the PSWD group; mean QALY scores were 0.362, 0.342 and 0.360, respectively. Mean health care costs were pound sterling105, pound sterling119 and pound sterling123 in the A&E, MT and PSWD groups, respectively. Mean societal costs were pound sterling373, pound sterling303 and pound sterling 338 in each group, respectively. Depending on the viewpoint and the outcome measure, A&E or MT were most likely to be the cost-effective interventions. PSWD was consistently the least cost-effective intervention.
CONCLUSIONS: The cost-effective intervention is likely to be A&E or MT, depending on the economic perspective and preferred outcome, but not PSWD.
STUDY DESIGN: Pragmatic, randomized, assessor blinded, clinical trial with economic analysis.
OBJECTIVE: To compare the effectiveness and cost-effectiveness of three kinds of physiotherapy commonly used to reduce disability in chronic low back pain.
SUMMARY OF BACKGROUND DATA: Physiotherapy reduces disability in chronic back pain, but there are several forms of physiotherapy and it is unclear which is most effective or cost effective.
METHODS: A total of 212 patients referred to physiotherapy with chronic low back pain were randomized to receive usual outpatient physiotherapy, spinal stabilization classes, or physiotherapist-led pain management classes. Primary outcome was Roland Disability Questionnaire score 18 months from baseline; secondary measures were pain, health-related quality of life, and time off work. Healthcare costs associated with low back pain and quality-adjusted life years (QALYs) were also measured. RESULTS.: A total of 71 participants were assigned to usual outpatient physiotherapy, 72 to spinal stabilization, and 69 to physiotherapist-led pain management. A total of 160 (75%) provided follow-up data at 18 months, showing similar improvements with all interventions: mean (95% confidence intervals) Roland Disability Questionnaire score improved from 11.1 (9.6-12.6) to 6.9 (5.3-8.4) with usual outpatient physiotherapy, 12.8 (11.4-14.2) to 6.8 (4.9-8.6) with spinal stabilization, and 11.5 (9.8-13.1) to 6.5 (4.5-8.6) following pain management classes. Pain, quality of life, and time off work also improved within all groups with no between-group differences. Mean (SD) healthcare costs and QALY gain were pound474 (840) and 0.99 (0.27) for individual physiotherapy, pound379 (1040) and 0.90 (0.37) for spinal stabilization, and pound165 (202) and 1.00 (0.28) for pain management.
CONCLUSIONS: For chronic low back pain, all three physiotherapy regimens improved disability and other relevant health outcomes, regardless of their content. Physiotherapist-led pain management classes offer a cost-effective alternative to usual outpatient physiotherapy and are associated with less healthcare use. A more widespread adoption of physiotherapist-led pain management could result in considerable cost savings for healthcare providers.
OBJECTIVE: Guidelines for the management of acute low back pain in primary care recommend early intervention to address psychosocial risk factors associated with long-term disability. We assessed the cost utility and cost effectiveness of a brief pain management program (BPM) targeting psychosocial factors compared with physical therapy (PT) for primary care patients with low back pain of <12 weeks' duration.
METHODS: A total of 402 patients were randomly assigned to BPM or PT. We adopted a health care perspective, examining the direct health care costs of low back pain. Outcome measures were quality-adjusted life years (QALYs) and 12-month change scores on the Roland and Morris disability questionnaire. Resource use data related to back pain were collected at 12-month followup. Cost effectiveness was expressed as incremental ratios, with uncertainty assessed using cost-effectiveness planes and acceptability curves.
RESULTS: There were no statistically significant differences in mean health care costs or outcomes between treatments. PT had marginally greater effectiveness at 12 months, albeit with greater health care costs (BPM 142 pounds, PT 195 pounds). The incremental cost-per-QALY ratio was 2,362 pounds. If the UK National Health Service were willing to pay 10,000 pound per additional QALY, there is only a 17% chance that BPM provides the best value for money.
CONCLUSION: PT is a cost-effective primary care management strategy for low back pain. However, the absence of a clinically superior treatment program raises the possibility that BPM could provide an additional primary care approach, administered in fewer sessions, allowing patient and doctor preferences to be considered.
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 pounds sterling (221 pounds sterling) for physiotherapy and 159 pounds sterling (260 pounds sterling) for the advice group. However, patients in the physiotherapy group had significantly higher out-of-pocket health care expenditure (40 pounds sterling, 95% confidence interval 9 pounds sterling to 71 pounds sterling). 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.
BACKGROUND: Passive joint mobilisation is a technique frequently used by physiotherapists to reduce pain, improve joint movement and facilitate a return to activities after injury, but its use after ankle fracture is currently based on limited evidence. The primary aim of this trial is to determine if adding joint mobilisation to a standard exercise programme is effective and cost-effective after cast immobilisation for ankle fracture in adults.
METHODS/DESIGN: Ninety participants will be recruited from the physiotherapy departments of three teaching hospitals and randomly allocated to treatment or control groups using a concealed procedure. All participants will perform an exercise programme. Participants in the treatment group will also receive joint mobilisation twice a week for four weeks. Blinded follow-up assessments will be conducted four, 12 and 24 weeks after randomisation. The primary outcome measures will be the Lower Extremity Functional Scale and the Assessment of Quality of Life. Secondary outcomes will include measures of impairments, activity limitation and participation. Data on the use of physiotherapy services and participants' out-of-pocket costs will be collected for the cost-effective and cost-utility analyses. To test the effects of treatment, between-group differences will be examined with analysis of covariance using a regression approach. The primary conclusions will be based on the four-week follow-up data.
DISCUSSION: This trial incorporates features known to minimise bias. It uses a pragmatic design to reflect clinical practice and maximise generalisability. Results from this trial will contribute to an evidence-based approach for rehabilitation after ankle fracture.
An economic evaluation alongside a randomized controlled trial comparing behavioral graded activity (BGA) with manual therapy (MT).
OBJECTIVE:
To evaluate the cost-effectiveness of BGA in comparison with MT for patients with subacute neck pain from a societal perspective.
SUMMARY OF BACKGROUND DATA:
Neck pain is common and poses an important socioeconomic burden to society. Data on the cost-effectiveness of treatments for neck pain are scarce.
METHODS:
A randomized clinical trial was conducted, involving 146 patients with subacute nonspecific neck pain. The BGA program can be described as a time-contingent increase in activities from baseline toward predetermined goals. MT consists of specific spinal mobilization techniques and exercises. Clinical outcomes included recovery, pain, disability, and quality-adjusted life-years (QALYs). Costs were measured from a societal perspective using cost diaries. The follow-up period was 52 weeks. Multiple imputation was used for missing cost and effect data. Uncertainty surrounding cost differences and incremental cost-effectiveness ratios was estimated using bootstrapping. Cost-effectiveness planes and cost-effectiveness acceptability (CEA) curves were estimated.
RESULTS:
BGA had no significant effect on recovery or QALYs gained in comparison with MT but pain and disability did improve significantly in the BGA group in comparison with the MT group. Total societal costs in the BGA group were nonsignificantly higher than in the MT group. Cost-effectiveness analyses showed that BGA is not cost-effective in comparison with MT for recovery and QALYs gained. Substantial investments are needed to reach a 0.95 probability that BGA is cost-effective in comparison with MT for pain and disability.
CONCLUSION:
On the basis of the data presented, we consider BGA not cost-effective in comparison with MT.
