Comparing exercise therapy to usual care for hip impingement

First-line Treatment for Femoroacetabular Impingement Syndrome: a Multicenter Randomized Controlled Trial Comparing a Supervised Strength Exercise Intervention to Usual Care on Hip-related Quality of Life. (Better Hip Trial)

This study is testing whether a supervised exercise program can help people with hip impingement feel better compared to regular care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: University of Aarhus (Academic / other)
• Locations: 6 sites (Melbourne and 5 other locations)
• Trial ID: NCT05927935 on ClinicalTrials.gov

What this trial studies

This trial aims to evaluate the effectiveness and cost-effectiveness of a supervised strength exercise intervention compared to usual first-line care for patients with femoroacetabular impingement syndrome (FAIS). It is a multicenter, randomized controlled trial conducted in Denmark and Australia, where eligible participants will be assigned to either the exercise intervention or usual care. The primary outcome will be assessed using the iHOT-33 scale to measure hip-related quality of life after 6 months, while a health economic evaluation will analyze cost-effectiveness at 12 months. Secondary outcomes will include various patient-reported and objective measures collected at multiple time points throughout the study.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 18-50 with activity-related hip pain lasting at least 3 months and specific radiographic findings indicative of femoroacetabular impingement.

Not a fit: Patients with a history of significant hip surgery, pre-existing osteoarthritis, or those who have undergone prior physiotherapy targeting the hip may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and cost-efficient treatment option for patients suffering from femoroacetabular impingement syndrome.

How similar studies have performed: While there is limited evidence on the effectiveness of first-line treatments for FAIS, similar approaches in exercise therapy have shown promise in other musculoskeletal conditions.

Eligibility criteria

Inclusion Criteria:

1. Activity- or position-related pain lasting ≥ 3 months
2. Positive Flexion-Adduction-Internal rotation (FADIR) test
3. Cam-type FAIS; x-ray alpha angle =\> 60 degrees
4. Pincer-type FAIS; lateral center edge angle \> 39 degrees or crossover-sign
5. Mixed-type FAIS; a combination of cam- and pincer-type impingement
6. Motivated to exercise 2 times a week for 6 months
7. 18-50 years old
8. Body Mass Index (BMI) score \< 35

Exclusion Criteria:

1. Physiotherapist-led strengthening exercises targeting the hip for at least 3 months for ≥ 6 sessions prior to inclusion
2. Previous hip surgery or other major hip injury in index hip (i.e., hip arthroscopy, fracture, calves perthes, necrosis or luxation).
3. Evidence of pre-existing osteoarthritis, defined as Tönnis grade ≥ 2 or Kellgreen-Lawrence ≥ 2
4. Evidence of pre-existing osteoarthritis, defined as lateral joint space width ≥ 3 mm (measured at the lateral sourcil).
5. Hip dysplasia, defined as a Center-Edge-angle (CE-angle) ≤ 25° and an acetabular index \> 10°
6. Comorbidities or other problems considered to affect hip function and participation in exercise
7. Unable to communicate in the respective languages of the participating countries

Where this trial is running

Melbourne and 5 other locations

• La Trobe University — Melbourne, Australia (Not_yet_recruiting)
• Odense University Hospital — Odense, Region of Southern Denmark, Denmark (Recruiting)
• Orthopaedic Center, Alborg sygehus, Aalborg University Hospital — Aalborg, Denmark (Recruiting)
• Aarhus University Hospital — Aarhus, Denmark (Recruiting)
• Horsens Regional Hospital — Horsens, Denmark (Recruiting)
• Hvidovre Hospital — Hvidovre, Denmark (Recruiting)

Study contacts

• Principal investigator: Frederik Foldager, MSc — Aarhus University Hospital and Aarhus University
• Study coordinator: Frederik Foldager, MSc

Conditions Femoroacetabular Impingement Syndrome; FAI; Hip; Usual care; Exercise Therapy; Health economic evaluation; Effectiveness