Comparing exercise and patient education with usual care in the treatment of hip dysplasia: a protocol for a randomised controlled trial with 6-month follow-up (MovetheHip trial)

TY - JOUR

T1 - Comparing exercise and patient education with usual care in the treatment of hip dysplasia

T2 - Fourth World Congress of Sports Physical Therapy

AU - Jacobsen, Julie Sandell

AU - Thorborg, Kristian

AU - Nielsen, Rasmus Østergaard

AU - Jakobsen, Stig Storgaard

AU - Foldager, Casper

AU - Sørensen, Dorthe

AU - Oestergaard, Lisa Gregersen

AU - van Tulder, Maurits W

AU - Mechlenburg, Inger

N1 - Conference code: 4

PY - 2022/9/20

Y1 - 2022/9/20

N2 - INTRODUCTION: Surgery is not a viable treatment for all patients with hip dysplasia. Currently, usual care for these patients is limited to a consultation on self-management. We have shown that an exercise and patient education intervention is a feasible and acceptable intervention for patients not receiving surgery. Therefore, we aim to investigate whether patients with hip dysplasia randomised to exercise and patient education have a different mean change in self-reported pain compared with those randomised to usual care over 6 months. Furthermore, we aim to evaluate the cost-effectiveness and perform a process evaluation.METHODS AND ANALYSIS: In a randomised controlled trial, 200 young and middle-aged patients will be randomised to either exercise and patient education or usual care at a 1:1 ratio through permuted block randomisation. The intervention group will receive exercise instruction and patient education over 6 months. The usual care group will receive one consultation on self-management of hip symptoms. The primary outcome is the self-reported mean change in the pain subscale of the Copenhagen Hip and Groin Outcome Score (HAGOS). Secondary outcomes include mean changes in the other HAGOS subscales, in the Short Version of the International Hip Outcome Tool, in performance, balance and maximal hip muscle strength. Between-group comparison from baseline to 6-month follow-up will be made with intention-to-treat analyses with a mixed-effects model. Cost-effectiveness will be evaluated by relating quality-adjusted life years and differences in HAGOS pain to differences in costs over 12 months. The functioning of the intervention will be evaluated as implementation, mechanisms of change and contextual factors.ETHICS AND DISSEMINATION: The study protocol was approved by the Committee on Health Research Ethics in the Central Denmark Region and registered at ClinicalTrials. Positive, negative and inconclusive findings will be disseminated through international peer-reviewed scientific journals and international conferences.TRIAL REGISTRATION NUMBER: NCT04795843.

AB - INTRODUCTION: Surgery is not a viable treatment for all patients with hip dysplasia. Currently, usual care for these patients is limited to a consultation on self-management. We have shown that an exercise and patient education intervention is a feasible and acceptable intervention for patients not receiving surgery. Therefore, we aim to investigate whether patients with hip dysplasia randomised to exercise and patient education have a different mean change in self-reported pain compared with those randomised to usual care over 6 months. Furthermore, we aim to evaluate the cost-effectiveness and perform a process evaluation.METHODS AND ANALYSIS: In a randomised controlled trial, 200 young and middle-aged patients will be randomised to either exercise and patient education or usual care at a 1:1 ratio through permuted block randomisation. The intervention group will receive exercise instruction and patient education over 6 months. The usual care group will receive one consultation on self-management of hip symptoms. The primary outcome is the self-reported mean change in the pain subscale of the Copenhagen Hip and Groin Outcome Score (HAGOS). Secondary outcomes include mean changes in the other HAGOS subscales, in the Short Version of the International Hip Outcome Tool, in performance, balance and maximal hip muscle strength. Between-group comparison from baseline to 6-month follow-up will be made with intention-to-treat analyses with a mixed-effects model. Cost-effectiveness will be evaluated by relating quality-adjusted life years and differences in HAGOS pain to differences in costs over 12 months. The functioning of the intervention will be evaluated as implementation, mechanisms of change and contextual factors.ETHICS AND DISSEMINATION: The study protocol was approved by the Committee on Health Research Ethics in the Central Denmark Region and registered at ClinicalTrials. Positive, negative and inconclusive findings will be disseminated through international peer-reviewed scientific journals and international conferences.TRIAL REGISTRATION NUMBER: NCT04795843.

KW - Hip

KW - Hip dysplasia

KW - Musculoskeletal conditions

KW - Physiotherapy

KW - Rehabilitation

UR - http://www.scopus.com/inward/record.url?scp=85138160294&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2022-064242

DO - 10.1136/bmjopen-2022-064242

M3 - Journal article

C2 - 36127096

SN - 2044-6055

VL - 12

JO - BMJ Open

JF - BMJ Open

IS - 9

M1 - e064242

Y2 - 26 August 2022 through 27 August 2022

ER -