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)

Julie Sandell Jacobsen, Kristian Thorborg, Rasmus Østergaard Nielsen, Stig Storgaard Jakobsen, Casper Foldager, Dorthe Sørensen, Lisa Gregersen Oestergaard, Maurits W van Tulder, Inger Mechlenburg, Julie Sandell Jacobsen, Kristian Thorborg, Rasmus Østergaard Nielsen, Stig Storgaard Jakobsen, Casper Foldager, Dorthe Sørensen, Lisa Gregersen Oestergaard, Maurits W van Tulder, Inger Mechlenburg

Abstract

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.

Keywords: Hip; Musculoskeletal disorders; REHABILITATION MEDICINE; SPORTS MEDICINE.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flow of participants through the trial. BMI, body mass index; HAGOS, Copenhagen Hip and Groin Outcome Score; PAO, periacetabular osteotomy.
Figure 2
Figure 2
Illustration of anticipated changes in the Copenhagen Hip and Groin Outcome Score (HAGOS) over a 6-month follow-up period. Values are mean (95% CIs). The mean score of the intervention group (exercise and patient education) is anticipated to change from 60 to 80 points, corresponding to an improvement of 20 points over 6 months. In contrast, the mean score of the control group (usual care) is anticipated to change from 60 to 65 points, corresponding to an improvement of 5 points over 6 months. These group-based improvements lead to a hypothesised between-group change difference of 15 points (95% CI 10 to 20). The lower limit of the 95% CI between-group change difference of 10 points represents the minimal clinically important difference (MCIC), which is described in our hypothesis and included in our power calculation.

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