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Open Access 01-12-2009 | Study protocol

Exercise and manual physiotherapy arthritis research trial (EMPART): a multicentre randomised controlled trial

Authors: Helen P French, Tara Cusack, Aisling Brennan, Breon White, Clare Gilsenan, Martina Fitzpatrick, Paul O'Connell, David Kane, Oliver FitzGerald, Geraldine M McCarthy

Published in: BMC Musculoskeletal Disorders | Issue 1/2009

Abstract

Background

Osteoarthritis (OA) of the hip is a major cause of functional disability and reduced quality of life. Management options aim to reduce pain and improve or maintain physical functioning. Current evidence indicates that therapeutic exercise has a beneficial but short-term effect on pain and disability, with poor long-term benefit. The optimal content, duration and type of exercise are yet to be ascertained. There has been little scientific investigation into the effectiveness of manual therapy in hip OA. Only one randomized controlled trial (RCT) found greater improvements in patient-perceived improvement and physical function with manual therapy, compared to exercise therapy.

Methods and design

An assessor-blind multicentre RCT will be undertaken to compare the effect of a combination of manual therapy and exercise therapy, exercise therapy only, and a waiting-list control on physical function in hip OA. One hundred and fifty people with a diagnosis of hip OA will be recruited and randomly allocated to one of 3 groups: exercise therapy, exercise therapy with manual therapy and a waiting-list control. Subjects in the intervention groups will attend physiotherapy for 6–8 sessions over 8 weeks. Those in the control group will remain on the waiting list until after this time and will then be re-randomised to one of the two intervention groups. Outcome measures will include physical function (WOMAC), pain severity (numerical rating scale), patient perceived change (7-point Likert scale), quality of life (SF-36), mood (hospital anxiety and depression scale), patient satisfaction, physical activity (IPAQ) and physical measures of range of motion, 50-foot walk and repeated sit-to stand tests.

Discussion

This RCT will compare the effectiveness of the addition of manual therapy to exercise therapy to exercise therapy only and a waiting-list control in hip OA. A high quality methodology will be used in keeping with CONSORT guidelines. The results will contribute to the evidence base regarding the clinical efficacy for physiotherapy interventions in hip OA.

Trial Registration

Number: NCT00709566

Available only for authorised users

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The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2474/10/9/prepub

Title: Exercise and manual physiotherapy arthritis research trial (EMPART): a multicentre randomised controlled trial
Authors: Helen P French
Tara Cusack
Aisling Brennan
Breon White
Clare Gilsenan
Martina Fitzpatrick
Paul O'Connell
David Kane
Oliver FitzGerald
Geraldine M McCarthy
Publication date: 01-12-2009
Publisher: BioMed Central
Published in: BMC Musculoskeletal Disorders / Issue 1/2009
Electronic ISSN: 1471-2474
DOI: https://doi.org/10.1186/1471-2474-10-9

At a glance: The STEP trials

Springer Medicine

Exercise and manual physiotherapy arthritis research trial (EMPART): a multicentre randomised controlled trial

Abstract

Background

Methods and design

Discussion

Trial Registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods and design

Discussion

Trial Registration

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