Clinical trial NCT03949127: Efficacy of an Exercise Program for Patients With Femoro-acetabular Impingement
Official title: Efficacy of a Non-surgical Treatment Protocol for Patients With Symptomatic Femoro-acetabular Impingement: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Femoracetabular Impingement
Keywords: non-surgical treatment
exercise
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Orthopaedic Foundation
First posted: 2019-05-14
Enrollment: 95
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two groups, one will be the exercise group and one will be used as a control group.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: iHOT-33
timeFrame: Change in Baseline before exercise program and 6 months
Secondary outcomes:
measure: EQ-5D-5L
timeFrame: Change in Baseline before exercise program and 6 months afterward
measure: Number of participants that receive hip surgery
timeFrame: Change in Baseline before exercise program and 1 year afterwards
measure: Patient-reported hip pain
timeFrame: Change in Baseline before exercise program and 6 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Paul Beaule, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
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