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Open Access Highly Accessed Study protocol

Effectiveness of joint mobilisation after cast immobilisation for ankle fracture: a protocol for a randomised controlled trial [ACTRN012605000143628]

C Christine Lin1*, Anne M Moseley1, Kathryn M Refshauge1, Marion Haas2 and Robert D Herbert1

Author Affiliations

1 School of Physiotherapy, the University of Sydney, PO Box 170, Lidcombe, New South Wales 1825, Australia

2 Centre for Health Economics Research and Evaluation (CHERE), University of Technology, Sydney, PO Box 123, Broadway, New South Wales 2007, Australia

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BMC Musculoskeletal Disorders 2006, 7:46  doi:10.1186/1471-2474-7-46

Published: 26 May 2006

Abstract

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.