Clinical trial NCT04502043: Exercise Therapy for Femoroacetabular Impingement Syndrome
Official title: The Effect of Patients' Characteristics on the Responsiveness to Exercise Therapy for the Management of Femoroacetabular Impingement Syndrome: a Multi-center, Single-group, Intervention Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Femoroacetabular Impingement Syndrome
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
Collaborators: name: Kantonsspital Winterthur KSW
First posted: 2020-08-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the clinical trial is to investigate the characteristics of patients, who respond vs. not respond to exercise therapy for the nonsurgical management of femoroacetabular impingement syndrome (FAIS).

Detailed description: Patients with a diagnosis of FAIS will be recruited from 2 clinical centers and will receive exercise therapy (study intervention). Exercise therapy is a semi-standardized intervention and will last 12 weeks (3 months). Hip pain, function and quality of life will be assessed using a patient-reported questionnaire at baseline, 3, 6 and 12 months' follow-up. Hip joint contact pressure will be evaluated using motion analysis and modelling at baseline, 3 and 12 months' follow-up. Hip morphology will be evaluated using imaging at baseline and hip surgery rate will be evaluated at 6 and 12 months' follow-up.

Eligibility criteria: Inclusion Criteria:

* Age: 18 to 50 years;
* Diagnosis of FAIS;
* Availability of magnetic resonance arthrography and anteroposterior pelvic radiography of the involved hip;
* Signed informed consent form.

Exclusion Criteria:

* Previous hip surgery;
* Any surgery on the lower extremities in the last 6 months;
* Hip dysplasia: lateral center edge angle \<25°;
* Hip osteoarthritis: Tönnis grade \>1;
* BMI: \>35 kg/m2;
* Significant cardiopulmonary diseases.

Primary outcomes:
measure: Change in hip pain, function and quality of life
timeFrame: Baseline to 6 months' follow-up
Secondary outcomes:
measure: Change in hip pain, function and quality of life
timeFrame: Baseline to 12 months' follow-up
measure: Change in hip pain, function and quality of life
timeFrame: Baseline to 3 months' follow-up
measure: Change in hip joint contact stress
timeFrame: Baseline to 3 months' follow-up
measure: Change in hip joint contact stress
timeFrame: Baseline to 12 months' follow-up
measure: Hip morphology
timeFrame: Baseline
measure: Change in sport activity level
timeFrame: Baseline to 3 months' follow-up
measure: Change in sport activity level
timeFrame: Baseline to 6 months' follow-up
measure: Change in sport activity level
timeFrame: Baseline to 12 months' follow-up
measure: Hip surgery rate
timeFrame: 6 months' follow-up
measure: Hip surgery rate
timeFrame: 12 months' follow-up
measure: Dropout
timeFrame: 3 months' follow-up
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Schulthess Clinic
Study officials:
affiliation: Schulthess Klinik
name: Nicola C Casartelli, PhD
role: PRINCIPAL_INVESTIGATOR
References: