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Management of Frozen Shoulder: A Systematic Review and Cost-Effectiveness Analysis
Health Technology Assessment, No. 16.11
E Maund, D Craig, S Suekarran, AR Neilson, K Wright, S Brealey, L Dennis, L Goodchild, N Hanchard, A Rangan, G Richardson, J Robertson, and C McDaid.
Author Information and AffiliationsSouthampton (UK): NIHR Journals Library; 2012 Mar.
Abstract
Background:
Frozen shoulder is condition in which movement of the shoulder becomes restricted. It can be described as either primary (idiopathic) whereby the aetiology is unknown, or secondary, when it can be attributed to another cause. It is commonly a self-limiting condition, of approximately 1 to 3 years' duration, though incomplete resolution can occur.
Objectives:
To evaluate the clinical effectiveness and cost-effectiveness of treatments for primary frozen shoulder, identify the most appropriate intervention by stage of condition and highlight any gaps in the evidence.
Data sources:
A systematic review was conducted. Nineteen databases and other sources including the Cumulative Index to Nursing and Allied Health (CINAHL), Science Citation Index, BIOSIS Previews and Database of Abstracts of Reviews of Effects (DARE) were searched up to March 2010 and EMBASE and MEDLINE up to January 2011, without language restrictions. MEDLINE, CINAHL and PsycINFO were searched in June 2010 for studies of patients' views about treatment.
Review methods:
Randomised controlled trials (RCTs) evaluating physical therapies, arthrographic distension, steroid injection, sodium hyaluronate injection, manipulation under anaesthesia, capsular release or watchful waiting, alone or in combination were eligible for inclusion. Patients with primary frozen shoulder (with or without diabetes) were included. Quasi-experimental studies were included in the absence of RCTs and case series for manipulation under anaesthesia (MUA) and capsular release only. Full economic evaluations meeting the intervention and population inclusion criteria of the clinical review were included. Two researchers independently screened studies for relevance based on the inclusion criteria. One reviewer extracted data and assessed study quality; this was checked by a second reviewer. The main outcomes of interest were pain, range of movement, function and disability, quality of life and adverse events. The analysis comprised a narrative synthesis and pair-wise meta-analysis. A mixed-treatment comparison (MTC) was also undertaken. An economic decision model was intended, but was found to be implausible because of a lack of available evidence. Resource use was estimated from clinical advisors and combined with quality-adjusted life-years obtained through mapping to present tentative cost-effectiveness results.
Results:
Thirty-one clinical effectiveness studies and one economic evaluation were included. The clinical effectiveness studies evaluated steroid injection, sodium hyaluronate, supervised neglect, physical therapy (mainly physiotherapy), acupuncture, MUA, distension and capsular release. Many of the studies identified were at high risk of bias. Because of variation in the interventions and comparators few studies could be pooled in a metaanalysis. Based on single RCTs, and for some outcomes only, short-wave diathermy may be more effective than home exercise. High-grade mobilisation may be more effective than low-grade mobilisation in a population in which most patients have already had treatment. Data from two RCTs showed that there may be benefit from adding a single intra-articular steroid injection to home exercise in patients with frozen shoulder of < 6 months' duration. The same two trials showed that there may be benefit from adding physiotherapy (including mobilisation) to a single steroid injection. Based on a network of nine studies the MTC found that steroid combined with physiotherapy was the only treatment showing a statistically and clinically significant beneficial treatment effect compared with placebo for short-term pain (standardised mean difference −1.58, 95% credible interval −2.96 to −0.42). This analysis was based on only a subset of the evidence, which may explain why the findings are only partly supportive of the main analysis. No studies of patients' views about the treatments were identified. Average costs ranged from £36.16 for unguided steroid injections to £2204 for capsular release. The findings of the mapping suggest a positive relationship between outcome and European Quality of Life-5 Dimensions (EQ-5D) score: a decreasing visual analogue scale score (less pain) was accompanied by an increasing (better) EQ-5D score. The one published economic evaluation suggested that low-grade mobilisation may be more cost-effective than high-grade mobilisation. Our tentative costeffectiveness analysis suggested that steroid alone may be more cost-effective than steroid plus physiotherapy or physiotherapy alone. These results are very uncertain.
Limitations:
The key limitation was the lack of data available. It was not possible to undertake the planned synthesis exploring the influence of stage of frozen shoulder or the presence of diabetes on treatment effect. As a result of study diversity and poor reporting of outcome data there were few instances where the planned quantitative synthesis was possible or appropriate. Most of the included studies had a small number of participants and may have been underpowered. The lack of available data made the development of a decision-analytic model implausible. We found little evidence on treatment related to stage of condition, treatment pathways, the impact on quality of life, associated resource use and no information on utilities. Without making a number of questionable assumptions modelling was not possible.
Conclusions:
There was limited clinical evidence on the effectiveness of treatments for primary frozen shoulder. The economic evidence was so limited that no conclusions can be made about the cost-effectiveness of the different treatments. High-quality primary research is required.
Funding:
The National Institute for Health Research Health Technology Assessment programme.
Contents
- NIHR Health Technology Assessment programme
- Glossary
- List of abbreviations
- Executive summary
- 1. Background
- 2. Methods
- 3. Results
- 4. Discussion
- 5. Conclusions
- Acknowledgements
- References
- Appendix 1 Search strategies for effectiveness review
- Appendix 2 Search strategy for review of views of people with frozen shoulder
- Appendix 3 R code for standard deviation
- Health Technology Assessment programme
- Appendix 4 Quality assessment checklist
- Appendix 5 List of excluded studies
- Appendix 6 Study details
- Appendix 7 Data extraction tables
- Appendix 8 Study quality
- Appendix 9 WinBUGS code
- Appendix 10 Mixed-treatment comparison
- Appendix 11 Economic evaluation study quality checklist
- Appendix 12 Economic evaluation data extraction/summary
- Appendix 13 Resource-use table
- Appendix 14 Exploratory mapping analysis
- Appendix 15 Protocol
Suggested citation:
Maund E, Craig D, Suekarran S, Neilson AR, Wright K, Brealey S, et al. Management of frozen shoulder: a systematic review and cost-effectiveness analysis. Health Technol Assess 2012;16(11).
Declared competing interests of authors: Amar Rangan has received consultancy fees from DePuy International relating to shoulder replacement prostheses. A division of DePuy is involved in marketing products for surgical treatment of the frozen shoulder. The other authors report no conflicts of interest.
The research reported in this issue of the journal was commissioned by the HTA programme as project number 09/13/02. The contractual start date was in March 2010. The draft report began editorial review in March 2011 and was accepted for publication in September 2011. As the funder, by devising a commissioning brief, the HTA programme specified the research question and study design. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors' report and would like to thank the referees for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.
The views expressed in this publication are those of the authors and not necessarily those of the HTA programme or the Department of Health.
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