Exercise Therapy for Femoroacetabular Impingement Syndrome

Femoroacetabular Impingement Syndrome Clinical Trial

— SWEaT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04502043
• Other study ID #: SchulthessKlinik
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: March 2024

Study information

• Verified date: December 2023
• Source: Schulthess Klinik
• Contact: Nicola C Casartelli, PhD
• Phone: 0443857971
• Email: nicola.casartelli[@]kws.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoroacetabular Impingement Syndrome
• Rotator Cuff Injuries
• Syndrome

Intervention

Other:
• Exercise therapy
Education Hip-specific strengthening exercises Functional lower limb strengthening exercises Core stability exercises Postural balance exercises

Locations

Country	Name	City	State
Switzerland	Schulthess Clinic	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Schulthess Klinik	Kantonsspital Winterthur KSW

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hip pain, function and quality of life	Hip pain, function and quality of life will be assessed using the International Hip Outcome Tool - 33 Items	Baseline to 6 months' follow-up
Secondary	Change in hip pain, function and quality of life	Hip pain, function and quality of life will be assessed using the International Hip Outcome Tool - 33 Items	Baseline to 12 months' follow-up
Secondary	Change in hip pain, function and quality of life	Hip pain, function and quality of life will be assessed using the International Hip Outcome Tool - 33 Items	Baseline to 3 months' follow-up
Secondary	Change in hip joint contact stress	Hip joint contact pressure will be assessed using modelling	Baseline to 3 months' follow-up
Secondary	Change in hip joint contact stress	Hip joint contact pressure will be assessed using modelling	Baseline to 12 months' follow-up
Secondary	Hip morphology	Hip morphology will be assessed using imaging	Baseline
Secondary	Change in sport activity level	Sport activity level will be assessed using the Hip Sports Activity Scale	Baseline to 3 months' follow-up
Secondary	Change in sport activity level	Sport activity level will be assessed using the Hip Sports Activity Scale	Baseline to 6 months' follow-up
Secondary	Change in sport activity level	Sport activity level will be assessed using the Hip Sports Activity Scale	Baseline to 12 months' follow-up
Secondary	Hip surgery rate	Number of patients who will decide to undergo hip surgery	6 months' follow-up
Secondary	Hip surgery rate	Number of patients who will decide to undergo hip surgery	12 months' follow-up
Secondary	Dropout	Number of patients who will not complete the non-surgical intervention protocol	3 months' follow-up