Clinical trial NCT04795843: Exercise and Patient Education Compared With Usual Care in Patients With Hip Dysplasia
Official title: MovetheHip-trial: The Effectiveness of Exercise and Patient Education Compared With Usual Care on Self-reported Pain in Patients With Hip Dysplasia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Dysplasia
Keywords: Hip Dislocation, Congenital
Exercise
Patient education
Usual care
Effectiveness
Cost-effectiveness
Process evaluation
Periacetabular osteotomy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Research Unit for General Practice, Aarhus University
name: VIA University College
name: Copenhagen University Hospital, Hvidovre
name: Defactum, Central Denmark Region
First posted: 2021-03-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This effectiveness trial will investigate if patients with hip dysplasia randomised to exercise and patient education have a different mean change in self-reported pain measured by the Copenhagen Hip and Groin Outcome Score (HAGOS) compared with those randomised to usual care over a six-month follow-up period.

Participating patients will be allocated to either exercise and patient education or usual care. Alongside this, a health-economic study and a process-evaluation study will be conducted.

Detailed description: This study is a parallel-group superiority randomised controlled trial. Alongside this, a health-economic study and a process-evaluation study will be conducted. Participating patients will be allocated to either exercise and patient education or usual care at a 1:1 ratio. The primary outcome is change in self-reported pain measured with Copenhagen Hip and Groin Outcome Score (HAGOS) from baseline to 6-month follow-up.

The effectiveness of exercise and patient education compared with usual care will be reported in the primary trial paper, including the primary outcome and the following secondary outcomes: HAGOS symptoms, HAGOS function in daily living (ADL), HAGOS function in sport and recreation (sport/recreation), HAGOS participation in physical activity (participation), HAGOS quality of life (QOL), the impact of hip disease with the Short Version of the International Hip Outcome Tool (iHOT-12), lower limb reach length (anterior, posteromedial, posterolateral), single-leg hip for distance (SLHD) test and hip muscle strength (flexion, extension and abduction).

The primary aim of this effectiveness trial is to investigate if patients with hip dysplasia randomised to exercise and patient education have a different mean change in self-reported pain measured by the Copenhagen Hip and Groin Outcome Score (HAGOS) compared with those randomised to usual care over a six-month follow-up period.

The primary hypothesis: Patients randomised to exercise and patient education will have a between-group mean change score on the HAGOS pain that is at least 10 points higher than those randomised to usual care over a 6-month follow-up period.

The secondary aims are to compare mean changes between the two groups on the other HAGOS subscales over a 6-month follow-up period. Similar comparisons will be made on self-reported mean changes in the Short Version of the International Hip Outcome Tool (iHOT-12) and mean changes in performance, balance and hip muscle strength.

A full trial protocol will be published and made publicly available. All primary and secondary outcomes will be analysed with the intention-to-treat principle. Between-group differences from baseline to 3-month and 6-month follow-up of continuous outcomes will be estimated using repeated measurement analysis in a mixed-effects model, including patient as a random effect, with a fixed factor for group and time and the corresponding interaction (Group × Time), adjusted for baseline values. Between-group differences of continuous outcomes from baseline to 6-month follow-up will be analysed with an unpaired t-test, where between-group differences of categorical data from baseline to 6-month follow-up will be analysed with a binominal regression model using risk difference as a measure of association. In this paper, all collected outcomes will be listed, and it will be described that the below listed will be reported in other papers (i.e. health-economic study and process-evaluation study) and secondary papers.

In the health-economic study, the investigators will investigate the cost-utility and cost-effectiveness of exercise and patient education compared with usual care over 12 months. Outcomes for this paper will be measured at baseline, 3-, 6-, 9- and 12-month follow-up. Incremental cost-effectiveness ratios (ICER) will be calculated by dividing the difference in costs by the difference in effects (quality-adjusted life years and HAGOS pain). The uncertainty around the ICER and 95% confidence intervals (CIs) surrounding the cost differences will be estimated with 95% bootstrapped CIs based on non-parametric bootstrapping and will be graphically presented on cost-effectiveness planes and cost-effectiveness acceptability curves.

In the process-evaluation study, the investigators will explore the functioning of the intervention by evaluating the implementation, mechanisms of change and the contribution of contextual factors over 6 months.

Implementation includes the implementation process, fidelity, dose and reach. The implementation process will evaluate the structures and resources through which delivery is achieved. Fidelity aspects will evaluate the extent to deliver each component as planned and registered during the intervention period using self-report questionnaires. The dose will evaluate how much intervention is delivered and registered during the intervention period using routine monitoring forms, and reach will be evaluated as patterns in uptake and adherence by baseline patient characteristics registered before and during the intervention period. Mechanisms of change include interactions between the intervention, the intervention providers and the patients. Interactions will be evaluated through four semi-structured focus group interviews with the intervention providers and the expert team (study coordinator, Kristian Thorborg and Julie S. Jacobsen) and quantitative data on reasons for not receiving surgery. Contextual factors will include events, personal understandings and interactions and their possible influence on the implementation. Contextual factors will be evaluated through one-to-one semi-structured interviews during and after the intervention period with 15-20 patients in the intervention group. Findings from quantitative and quantitative analyses will be merged, interpreted and reported jointly.

The below listed will be reported in secondary papers with a clear reference to the primary trial paper and trial registration, and it will hold "secondary analyses from a randomised controlled trial" in the title.

By using subgroup stratification, we will explore if muscle-tendon pain and pain sensitisation modify between-group changes of the primary and secondary outcomes over 6 months. Furthermore, we plan to conduct an instrumental variable analysis on primary and secondary outcomes in an attempt to investigate the efficacy of the intervention. These analyses will be reported in secondary papers with clear reference to the primary trial paper.

In addition, the investigators plan to evaluate the psychometric properties of HAGOS and iHOT-12 in patients with hip dysplasia, and finally, the investigators plan to describe if hip osteoarthritis progresses over 5 and 10 years using the Tönnis osteoarthritis classification.

Eligibility criteria: Inclusion Criteria:

* Radiographically verified hip dysplasia by a Wiberg's centre edge (CE) angle of 10-25 degrees and an acetabular Index (AI) angle \>10 degrees
* Hip and/or groin pain as primary pain for at least three months
* Candidate for periacetabular osteotomy (PAO) but unwilling to undergo PAO, or on a waiting list for surgery (PAO) for 12 months or longer
* Not candidate for PAO (negative impingement test, BMI \>25, hip osteoarthritis, age \>45 years or reduced hip range of motion)

Exclusion Criteria:

* Self-reported pain score \>80 points measured with Copenhagen Hip and Groin outcome score
* Any major planned surgery (i.e. arthroplastic surgery or discectomy surgery)
* BMI \>35
* Acetabular retroversion defined by crossover sign and posterior wall sign
* Calvé Legg Perthes or epiphysiolysis
* Previous pelvic/hip surgery in index limb
* Previous pelvic/hip surgery within the last 2 years in contralateral limb
* Previous surgery due to herniated disc or spondylodesis
* Previous arthroplastic surgery in the hip, knee or ankle
* Physical (pregnancy/trauma), neurological, medical or rheumatic conditions severely affecting the hip function
* Inadequacy in written and spoken Danish, mental illness or other conditions affecting the ability to follow mandatory procedures for participation

Primary outcomes:
measure: Change in self-reported pain measured with The Copenhagen Hip and Groin Outcome Score (HAGOS) (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up (health economic study) and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
Secondary outcomes:
measure: Change in self-reported symptoms measured with HAGOS (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
measure: Change in self-reported physical function, daily living (ADL) measured with HAGOS (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
measure: Change in self-reported physical function in sports and recreational activities (sport/recreation) measured with HAGOS (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
measure: Change in self-reported participation in physical activities (participation) measured with HAGOS (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
measure: Change in self-reported quality of life (QOL) measured with HAGOS (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
measure: Change in impact of hip disease using the Short Version of the International Hip Outcome Tool (iHOT- 12) (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up. In addition at 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
measure: Change in anterior lower limb reach distance measured with the Y-balance test (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
measure: Change in posteromedial lower limb reach distance measured with the Y-balance test (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
measure: Change in posterolateral lower limb reach distance measured with the Y-balance test (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
measure: Change in single-leg jump distance measured with single-leg hop for distance test (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
measure: Change in isometric hip flexion strength using a dynamometer with external belt-fixation (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
measure: Change in isometric hip extension strength using a dynamometer with external belt-fixation (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
measure: Change in isometric hip abduction strength using a dynamometer with external belt-fixation (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
Other outcomes:
measure: Self-reported acceptable symptom state using the Patient Acceptable Symptom State (PASS) (dichotome data)
timeFrame: Measured at 6- and 12-month follow-up
measure: Change in self-reported hip and/or groin pain intensity measured with a 100 mm Visual Analogue Scale (VAS) for pain in rest (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline, 6- and 12-month follow-up
measure: Change in self-reported hip and/or groin pain intensity measured with a 100 mm Visual Analogue Scale (VAS) for pain during physical activity (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline, 6- and 12-month follow-up
measure: Change in self-reported back pain intensity measured with a 100 mm Visual Analogue Scale (VAS) for pain in rest (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline, 6- and 12-month follow-up
measure: Change in self-reported back pain intensity measured with a 100 mm Visual Analogue Scale (VAS) for pain in activity (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline, 6- and 12-month follow-up
measure: Trust in the capability of the hip with a 100 mm Visual Analog Scale (0-100, 100 best) for trust during the single-leg hop for distance test (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
measure: Change in self-reported hip and/or groin pain during hip flexion strength test measured on a numerical rating scale (NRS) for pain (categorical data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
measure: Change in self-reported hip and/or groin pain during hip extension strength test measured on a numerical rating scale (NRS) for pain (categorical data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
measure: Change in self-reported hip and/or groin pain during hip abduction strength test measured on a numerical rating scale (NRS) for pain (categorical data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
measure: Change in self-reported usage of analgesics (y/n/type/dose)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
measure: Number of serious adverse events (SAE) and adverse events (AE) related to the interventions, clinical assessments or conduct of the trial within the intervention period (continuous data)
timeFrame: From baseline to 6-month follow-up.
measure: Adherence measured by the 6-item Exercise Adherence Rating Scale (EARS) (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at 3- and 6-month follow-up
measure: Adherence measured at number of completed training sessions (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured every week.
measure: Change in quality-adjusted life years (QALYs) measured with EuroQoL 5-dimension (EQ-5D-5L) and valued using preference weights (continuous data)
timeFrame: From baseline to 12-month follow-up. Outcome measured at baseline, 3-, 6-, 9- and 12-month follow-up
measure: Productivity loss measured with Productivity Costs Questionnaire (IPCQ) (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline, 3-, 6-, 9- and 12-month follow-up
measure: Change in muscle-tendon pain in the iliopsoas measured with a pain-provocation test (dichotomous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
measure: Change in muscle-tendon pain in the abductors measured with a pain-provocation test (dichotomous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
measure: Change in temporal summation of pain (TS) at the hip (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
measure: Change in temporal summation of pain (TS) at the forearm (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
measure: Change in pressure pain threshold (PPT) at the hip (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
measure: Change in pressure pain threshold (PPT) at the forearm (continuous data)
timeFrame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
measure: Change in osteoarthritis grade measured by the Tönnis osteoarthritis classification (categorical data)
timeFrame: From baseline to 5- and 10-years follow-up. Outcome measured at baseline and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
measure: Number of other treatments received by the patients (number and text)
timeFrame: From baseline to 12-month follow-up (Health economic study). Outcome measured at 3- 6-, 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
city: Silkeborg
country: Denmark
facility: Silkeborg Regional Hospital.
Study officials:
affiliation: VIA University College
name: Julie S Jacobsen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital
name: Inger Mechlenburg, DMSc
role: STUDY_DIRECTOR
affiliation: Copenhagen University Hospital, Hvidovre
name: Kristian Thorborg, PhD
role: STUDY_CHAIR
affiliation: University of Aarhus
name: Rasmus Ø Nielsen, PhD
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Stig S Jakobsen, PhD
role: STUDY_CHAIR
affiliation: Defactum, Central Denmark Region
name: Lisa G Oestergaard, PhD
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Kjeld Søballe, PhD
role: STUDY_CHAIR
References:
citation: Jacobsen JS, Thorborg K, Nielsen RO, Jakobsen SS, Foldager C, Sorensen D, Oestergaard LG, van Tulder MW, Mechlenburg I. 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). BMJ Open. 2022 Sep 20;12(9):e064242. doi: 10.1136/bmjopen-2022-064242.