Efficacy of an Exercise Program for Patients With Femoro-acetabular Impingement

January 2, 2024 updated by: Ottawa Hospital Research Institute

Efficacy of a Non-surgical Treatment Protocol for Patients With Symptomatic Femoro-acetabular Impingement: a Randomized Controlled Trial

The purpose of this study is to examine whether using an exercise regime on people with femoroacetabular impingement (FAI) can help reduce pain and improve function. Also, it examines whether the exercise regime will help prevent the worsening of hip cartilage deterioration.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A significant proportion of adults from ages 18 to 50 have a deformity in the neck of their femur. This can be painful and is called a femoroacetabular impingement (FAI), and could lead to ones cartilage being destroyed and possibly lead to osteoarthritis of the hip. People with this deformity in their femur have been found to move their hips differently when doing tasks such as walking, squatting or climbing stairs compared to those without this problem. The investigators are testing whether exercise that targets this difference in movement can help reduce pain, improve function and prevent cartilage damage. There will recruit 84 patients with divided into 2 groups. 42 patients will do a 8 week exercise program on strengthening muscles responsible for extending the hip and stretching muscles that are associated with flexing the hip. The intensity of the program will change with visits to the physiotherapist through the course of their exercise program. This research hopes to develop an innovative, non-surgical, low-cost, highly feasible and accessible intervention for patients with FAI.

Study Type

Interventional

Enrollment (Estimated)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with symptomatic FAI
  • at least 3 months of groin pain
  • increased pain with hip rotation
  • an alpha angle greater than 60 degrees on multiplane imaging
  • labral tear on MRI
  • Tonnis grade of 0 or 1

Exclusion Criteria:

  • diagnosed health problems other than FAI interfering with capacity to accomplish the exercise program
  • previous hip surgery on the affected side
  • surgery will happen within 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Group
The group who will exercise to manage pain.
Other: Exercise Group
The group who will meet a physiotherapist who will show them strengthening and stretching muscles associated with pelvic tilt.
No Intervention: Control Group
The group who will not take part in any exercises and only have to do assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
iHOT-33
Time Frame: Change in Baseline before exercise program and 6 months
International Hip Outcome Tool-33, disease-specific function. Each answer will be measured on a scale of 100mm and the mean of the 33 questions will be taken as a final score. A higher score indicates a better quality of life.
Change in Baseline before exercise program and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants that receive hip surgery
Time Frame: Change in Baseline before exercise program and 1 year afterwards
If the participant has hip surgery in the time frame
Change in Baseline before exercise program and 1 year afterwards
EQ-5D-5L
Time Frame: Change in Baseline before exercise program and 6 months afterward
Generic quality of life, the scores for each question are summed up for a total with a higher score being a better quality of life.
Change in Baseline before exercise program and 6 months afterward
Patient-reported hip pain
Time Frame: Change in Baseline before exercise program and 6 months
Patient perceived pain on a VAS scale
Change in Baseline before exercise program and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Collaborators

Canadian Orthopaedic Foundation

Investigators

  • Principal Investigator: Paul Beaule, MD, FRCSC, Ottawa Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2019

Primary Completion (Actual)

July 4, 2023

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

April 14, 2019

First Submitted That Met QC Criteria

May 10, 2019

First Posted (Actual)

May 14, 2019

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20190091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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