First-line Treatment for Femoroacetabular Impingement Syndrome
There is sparse evidence on the effectiveness of first-line treatment in patients with femoroacetabular impingement syndrome (FAIS) regarding clinical- and cost-effectiveness. The goal of this randomized controlled trial is to compare the clinical effectiveness and cost-effectiveness of a supervised strength exercise intervention to usual first-line care in patients with FAIS. The main hypothesis it aims to investigate are: 1.
6-months of supervised strength exercise intervention is superior (i. e. , at least 6 points, on a scale from 0-100) to usual care in improving hip related quality of life in patients with FAIS at the end of intervention.
2. 6-months of supervised strength exercise intervention is cost-effective compared to usual first-line care at 12-month follow-up in patients with FAIS. 3.
High exercise adherence and dosage will be superior to low exercise adherence and dosage in mediating clinical effectiveness in patients with FAIS.
Study details:
There is sparse evidence on the effectiveness of first-line treatment in patients with femoroacetabular impingement syndrome (FAIS) regarding clinical- and cost-effectiveness. The Better Hip trial is a multicenter, stratified (by hospital site), randomized (allocation 1:1), controlled, assessor blinded, superiority trial conducted in Denmark (Aarhus, Horsens, Aalborg, and Odense) and Australia (Melbourne). Eligible patients will either be randomized to a supervised strength exercise intervention or to usual care.
The primary outcome will be hip-related quality of life measured at end of intervention (6 months) with the iHOT-33. A health economic evaluation will assess the difference in cost-effectiveness between groups from baseline to 12 months. Secondary outcomes will be measured at baseline, 3-, 6- and 12- months after initiating the intervention for patient reported outcome measures (PROMs), and at baseline and 6-months for objective outcome measures obtained at clinical assessments.
This trial aims to investigate the clinical and cost-effectiveness of a supervised strength exercise intervention compared to usual care as first-line treatment in patients with FAIS. A secondary aim is to explore how exercise adherence and dosage of a supervised strength exercise intervention mediates outcomes. The investigators hypothesis that;.
1. 6-months of supervised strength exercise intervention is superior (i. e.
, at least 6 points, on a scale from 0-100) to usual care in improving hip related quality of life in patients with FAIS at the end of intervention. 2. 6-months of supervised strength exercise intervention is cost-effective compared to usual first-line care at 12-month follow-up in patients with FAIS.
3. High exercise adherence and dosage will be superior to low exercise adherence and dosage in mediating clinical effectiveness in patients with FAIS. A full trial protocol will be published and made publicly available prior to analysis for the primary paper.
All primary and secondary outcomes will be analysed with the intention-to-treat principle. Supplementary to the intention-to-treat analysis a per protocol analysis will be conducted. Between-group differences will be analyzed using a linear mixed effect model for continuous outcomes and a logistical mixed effect model for binary outcome variables.
Intervention group, recruitment site and time will be included as fixed effects and patients will be included as a random effect. Incremental cost-effectiveness ratios (ICER) will be calculated by dividing the difference in costs by the difference in effects (quality-adjusted life years for cost-utility and iHOT-33 for cost-effectiveness).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Activity- or position-related pain lasting ≥ 3 months
- Positive Flexion-Adduction-Internal rotation (FADIR) test
- Cam-type FAIS; x-ray alpha angle => 60 degrees
- Pincer-type FAIS; lateral center edge angle > 39 degrees or crossover-sign
- Mixed-type FAIS; a combination of cam- and pincer-type impingement
- Motivated to exercise 2 times a week for 6 months
- 18-50 years old
- Body Mass Index (BMI) score < 35
Exclusion criteria
- Physiotherapist-led strengthening exercises targeting the hip for at least 3 months for ≥ 6 sessions prior to inclusion
- Previous hip surgery or other major hip injury in index hip (i.e., hip arthroscopy, fracture, calves perthes, necrosis or luxation)
- Evidence of pre-existing osteoarthritis, defined as Tönnis grade ≥ 2 or Kellgreen-Lawrence ≥ 2
- Evidence of pre-existing osteoarthritis, defined as lateral joint space width ≥ 3 mm (measured at the lateral sourcil)
- Hip dysplasia, defined as a Center-Edge-angle (CE-angle) ≤ 25° and an acetabular index > 10°
- Comorbidities or other problems considered to affect hip function and participation in exercise
- Unable to communicate in the respective languages of the participating countries
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- NA
Study ID
NCT05927935
Intervention or treatment
OTHER: Supervised strength exercise intervention
OTHER: Minimal educational intervention (usual care)
Conditions
- Femoroacetabular Impingement Syndrome
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Research sites nearby
Closest Location:
La Trobe University
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La Trobe University
Melbourne, Australia
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Who is running the clinical trial?
University of Aarhus
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Supervised strength exercise intervention
| Other: Supervised strength exercise intervention |
ACTIVE_COMPARATOR: Usual care
| Other: Minimal educational intervention (usual care) |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Change in hip-related quality of life measured by the International Hip and Outcome Tool 33 (iHOT-33) at end of intervention. | The iHOT-33 is a 33-item self-administered valid and reliable outcome measure based on a Visual Analogue Scale response format designed for young and active population with hip pathology. The total score ranges from 0 to 100, with higher scores indicating better hip-related quality of life. | Measured at baseline, 3, 6 and 12 months. |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Change in muscle strength measured by the unilateral one-repetition-maximum (1 RM) leg press test at end of intervention. | Maximal lower extremity strength is measured by a 1 RM test in a leg press resistance training machine. | Measured at baseline and 6 months. |
| Change in functional performance measured by the One-Leg Rise Test (number of repetitions) at end of intervention. | The One-Leg Rise Test is a reliable global measure of lower limb strength and endurance. | Measured at baseline and 6 months. |
| Change in functional performance measured by the Single leg hop for distance test at end of intervention. | The single-leg hop for distance test is a reliable functional performance test evaluating power generation and absorption. | Measured at baseline and 6 months. |
| Exercise level | Exercise level (1-3), higher level indicating higher level of difficulty in exercises. | Registered throughout the 6 month intervention in the supervised strength exercise intervention. |
| Number of sets | Number of sets (0-3), higher indicating completion of more sets in each exercise sessions. Number of sets will be used to calculate exercise dosage. | Registered throughout the 6 month intervention in the supervised strength exercise intervention. |
| Number of repetitions | Number of repetitions, higher indication completion of more repetitions in each exercise session. Number of repetitions will be used to calculate exercise dosage. | Registered throughout the 6 month intervention in the supervised strength exercise intervention. |
| External load | External load will be used to calculate exercise dosage. | Registered throughout the 6 month intervention in the supervised strength exercise intervention. |
| Rate of perceived exertion | Rate of perceived exertion (0-10), higher scores indicating larger perceived effort. | Registered throughout the 6 month intervention in the supervised strength exercise intervention. |
| The highest level of symptoms beyond which patients considers themselves well measured by the Patient Acceptable Symptom State (PASS) | Patient Acceptable Symptom State (PASS), defined as the value beyond which patients consider themselves well is evaluated using a single question. The scale is binary (yes/no). | Measured at baseline, 6 and 12 months. |
| Global Perceived Effect (GPE) | The GPE will be used as a measure of patient-rated recovery and will be assessed for three domains; pain, activities of daily living, and quality of life rated on a 7-point Likert scale ranging from 'Worse, an important worsening' (worst) to 'Better, an important improvement' (best) | Measured at 6 and 12 months. |
| Hip surgery | Number of hip surgeries within the follow-up period. | Measured at baseline, 3, 6 and 12 months. |
| AE (Adverse Events) & Serious Adverse Events (SAE) | Continuous registration of health issues and injuries. The events will be monitored by the physiotherapists supervising the exercise sessions. Further, patients will be asked at 6- and 12-month follow-ups about potential AE and SAE using open-probe questions. | Registered throughout the 12-month study period. |
| Drop-outs | Number of drop-out from the intervention groups. | Registered throughout the 12-month study period. |
References
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