Femoroacetabular Impingement Syndrome
Conditions
Keywords
Femoroacetabular Impingement Syndrome, FAI, Hip, Usual care, Exercise Therapy, Health economic evaluation, Effectiveness
Brief 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.
Detailed description
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)
Interventions
OTHERSupervised 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.
OTHERMinimal 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
University of Aarhus
Horsens Hospital
Aalborg University Hospital
Aarhus University Hospital
Odense University Hospital
La Trobe University
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Masking is single-blinded to the outcome assessor, whom is unaware of the participant's treatment group. The outcome assessor is blinded to the allocation of the participant´s and participant's are asked not to disclose their allocation during test.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hip-related quality of life measured by the International Hip and Outcome Tool 33 (iHOT-33) at end of intervention. | Measured at baseline, 3, 6 and 12 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in muscle strength measured by the unilateral one-repetition-maximum (1 RM) leg press test at end of intervention. | Measured at baseline and 6 months. | Maximal lower extremity strength is measured by a 1 RM test in a leg press resistance training machine. |
| Change in functional performance measured by the One-Leg Rise Test (number of repetitions) at end of intervention. | Measured at baseline and 6 months. | The One-Leg Rise Test is a reliable global measure of lower limb strength and endurance. |
| Change in functional performance measured by the Single leg hop for distance test at end of intervention. | Measured at baseline and 6 months. | The single-leg hop for distance test is a reliable functional performance test evaluating power generation and absorption. |
| Exercise level | Registered throughout the 6 month intervention in the supervised strength exercise intervention. | Exercise level (1-3), higher level indicating higher level of difficulty in exercises. |
| Number of sets | Registered throughout the 6 month intervention in the supervised strength exercise intervention. | 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. |
| Number of repetitions | Registered throughout the 6 month intervention in the supervised strength exercise intervention. | Number of repetitions, higher indication completion of more repetitions in each exercise session. Number of repetitions will be used to calculate exercise dosage. |
| External load | Registered throughout the 6 month intervention in the supervised strength exercise intervention. | External load will be used to calculate exercise dosage. |
| Rate of perceived exertion | Registered throughout the 6 month intervention in the supervised strength exercise intervention. | Rate of perceived exertion (0-10), higher scores indicating larger perceived effort. |
| The highest level of symptoms beyond which patients considers themselves well measured by the Patient Acceptable Symptom State (PASS) | Measured at baseline, 6 and 12 months. | 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). |
| Global Perceived Effect (GPE) | Measured at 6 and 12 months. | 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) |
| Hip surgery | Measured at baseline, 3, 6 and 12 months. | Number of hip surgeries within the follow-up period. |
| AE (Adverse Events) & Serious Adverse Events (SAE) | Registered throughout the 12-month study period. | 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. |
| Drop-outs | Registered throughout the 12-month study period. | Number of drop-out from the intervention groups. |
Countries
Australia, Denmark
Contacts
PRINCIPAL_INVESTIGATORFrederik Foldager, MSc
Aarhus University Hospital and Aarhus University
STUDY_DIRECTORInger Mechlenburg, Prof.
Aarhus University Hospital and Aarhus University
STUDY_DIRECTORSigne Kierkegaard-Brøchner, Postdoc
Horsens Regional Hospital and Aarhus University
STUDY_DIRECTORJoanne Kemp, Ass. Prof.
Latrobe Sports Exercise Medicine Research Centre, School of Allied Health, La Trobe University
Outcome results
None listed