First-line Treatment for Femoroacetabular Impingement Syndrome

Summary

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.

Conditions

• Femoroacetabular Impingement Syndrome

Interventions

OTHER

Supervised strength exercise intervention

A 6 months exercise intervention of training 2 times a week. Patients will be instructed by a physiotherapist during the first session, in order to be able to perform the exercises at home or in a local gymnasium based on personal preference. Subsequently, there are supervised sessions once every second week (12 sessions in total). The intervention will consist of 6 exercises. 4 targeting planes of hip movement (i.e., flexion, extension, abduction and adduction), a general lower extremity- and a trunk exercise. Progression is made when an exercise is performed with the designated number of sets and repetitions, with good performance quality and tolerable pain. Progression is provided by 3 levels of difficulty and secondly by the number of repetitions or where possible by increasing the external load. In addition, patient information and education is identical to what is delivered in the usual care group.

OTHER

Minimal educational intervention (usual care)

Usual care varies slightly across regions in Denmark and between Denmark and Australia. The consensus is that the patient should be advised to remain physically active and reduce symptom provoking activities. Therefore, patients will receive a referral for physiotherapy and supplementary a minimal educational intervention is provided as usual care. Patients allocated to the usual care group will receive written information on self-management of hip symptoms including advice about staying physically active in accordance with the World Health Organization guidelines on physical activity and sedentary behavior. Moreover, self-management of hip symptoms will include advice to reduce symptoms by focusing on symptom-lowering activities and sports. The content of the information provided as usual care will be identical to the information provided to the patients in the intervention group. Patients in the usual care group can continue to seek any additional treatment they would like.

Sponsors & Collaborators

• Aarhus University Hospital

  collaborator OTHER

• Horsens Hospital

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• La Trobe University

  collaborator OTHER

• Hvidovre University Hospital

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Frederik Foldager, MSc · Aarhus University Hospital and Aarhus University

• Inger Mechlenburg, Prof. · Aarhus University Hospital and Aarhus University

• Signe Kierkegaard-Brøchner, Postdoc · Horsens Regional Hospital and Aarhus University

• Joanne Kemp, Ass. Prof. · Latrobe Sports Exercise Medicine Research Centre, School of Allied Health, La Trobe University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-01

Primary Completion

2026-07-01

Completion

2027-07-01

Countries

• Australia
• Denmark

Study Locations