the Horsens Aarhus FemoroAcetabular Impingement Syndrome Training Pilot Study

Femoroacetabular Impingement Clinical Trial

Official title:

the Horsens Aarhus FemoroAcetabular Impingement Syndrome Training Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05031390
• Other study ID #: 1-16-02-724-18
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: August 2021
• Source: Horsens Hospital
• Contact: Signe Kierkegaard, PhD
• Phone: 004578427882
• Email: signkier[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to investigate the feasibility of a training intervention in patients with femoroacetabular impingement syndrome (FAIS).

Description:

The aim of this study is to investigate the feasibility of a 12-weeks (progressive) exercise program in patients with FAIS. Feasibility is evaluated on the recruitment strategy, patient adherence to the exercises and their experiences with and motivation for performing exercises. Furthermore, the investigators wish to investigate the variation of data before and after the exercise program to help estimate a suitable sample size for a future randomized controlled trial.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Patients aged 18-50 years old

2. Diagnosed with FAIS according to the Warwick agreement

3. Patients having cam morphology should have an alpha angle of > 55 degrees on an anterior-posterior radiograph.

4. Patients having pincer should have a lateral centre edge angle of >39 degrees on an anterior-posterior radiograph.

5. Lateral joint space width should be >3 mm.

6. Body mass index is below 30.

7. Motivated for participation in a 12 week training program with 8 physical attendances.

Exclusion Criteria:

1. Received physiotherapist-led treatment in the past 3 months,

2. Previous hip surgery in included hip or other major hip injury,

3. Systemic conditions e.g. rheumatoid arthritis, cancer,

4. Chronical pain syndromes,

5. Unable to perform testing procedures,

6. Unable to attend a 12-week treatment program or baseline and follow-up assessments

7. Contraindications to radiographs (e.g. pregnancy)

8. Unable to read or understand questionnaires and/or instructions

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoroacetabular Impingement

Intervention

Procedure:
• Physiotherapist-led training
Patients will undergo a 12-week physiotherapist-led training program consisting of 8 supervised sessions and home-based training in between

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Horsens Hospital	La Trobe University, University of Aarhus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of completed exercise sessions	Number of completed exercise sessions. A high adherence is defined as attendance of > 75% of planned sessions	0-12 weeks
Primary	Completion of training program	The training program is considered completed if patients are not dropping out of the study before the end of the 12 weeks. Completion rate will be calculated as % patients who completed the study	0-12 weeks
Secondary	The Copenhagen Hip and Groin Outcome Score (HAGOS)	HAGOS is a questionnaire developed for young, active persons experiencing hip and/or groin pain. It consists of 6 subscales: Pain, Symptoms, Activities of Daily Living, Sport, Participation in Sport and Hip-related quality of life. The main subscales used in this study are HAGOS pain and sport.	Change from 0-12 weeks
Secondary	The International Hip Outcome Tool (iHOT-33)	iHOT-33 is a questionnaire focussing at patients' hip related quality of life in 33 questions. Both a total score and sub scales: "Symptoms and functional limitations", "Sports and recreational activities", "Job related concerns" and "Social, emotional and lifestyle concerns", are extracted from the questionnaire.	Change from 0-12 weeks
Secondary	The Hip Sports Activity Scale (HSAS)	Current physical activity measured from 0 to 8 points, 0 being no activity and 8 being an athlete	Change from 0-12 weeks
Secondary	Maximal hip muscle strength	Change (Nm/kg) in maximal hip flexion, extension, abduction and adduction from 0-12 weeks	Change from 0-12 weeks
Secondary	One-legged hop for distance	Change (cm) i hop distance from 0-12 weeks	0-12 weeks
Secondary	Y-balance board	Change (cm) in ability to perform on the y balance board from 0-12 weeks	0-12 weeks
Secondary	Patient Acceptable Symptom State	Patient Acceptable Symptom State (yes/no): Change in number of patients reporting yes vs. no from baseline to 12 weeks	0-12 weeks