Conservative Intervention of Femoroacetabular Impingement Syndrome

Study Overview
=================
Brief Summary
-----------------
Purpose: 1) compare three conservative treatment approaches for subjects with femoroacetabular impingement syndrome (FAI), and 2) analyze functional outcome comparatively across groups. Interventions will be provided based on randomized assignment. Group 1 will receive treatment based on identified impairments and treated twice weekly to address said impairments with hip manual therapy and exercise, as well as a prescriptive exercise for strengthening and mobility of the hip. Group 2 will receive only the prescriptive exercise program. Group 3 will be a control group (supervised neglect) Primary outcomes data analysis will involve a mixed design (repeated measures) ANOVA for assessment of the primary outcome measure of the HAGOS. Secondary analyses will include chi square analyses (PASS, surgery at 6 months, adverse events), ANCOVA (PPMs, and expectations measures), or other appropriate comparative measures. None of the proposed treatment is considered outside of 'standard of practice'.

Official Title
-----------------
Conservative Intervention of Femoroacetabular Impingement Syndrome: A Randomized Controlled Trial

Conditions
-----------------
Femoroacetabular Impingement

Intervention / Treatment
-----------------
* Other: Manual therapy
* Other: Exercise
* Other: Education and advice
* Other: Supervised neglect


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals age 18 to 60 years, diagnosed with FAI by an orthopedic surgeon and exhibiting hip/groin symptoms for at least 3 months (symptomatic); and signs, symptoms and imaging findings conducive to FAI will be recruited from a surgical practice of an orthopedic surgeon in Durham, North Carolina. Exclusion Criteria: subjects that have radiographic evidence of hip osteoarthritis that is more than mild in severity defined as Tonnis >grade 1 or Kellgren-Lawrence >2; have other concurrent injury/conditions that will affect their ability to participate in the rehabilitation program and/or assessment procedures; exhibit hip dysplasia (center edge angle <20 degrees on AP radiograph are unable to attend a study physiotherapist or participate in the rehabilitation program if randomized to the PT group; are unable to understand English.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education, exercise and manual therapy<br>One group will receive education and advice, manual therapy that is applied toward the impairments of the subject, a prescription of progressive rehabilitation exercises designed to strengthen weakened muscle groups and stretch joint movements that demonstrate range of motion limitations. Treatment is based on clinical presentation and identification of impairments by the treating clinician. Subjects will be seen twice weekly for 4 to 6 weeks, depending on the progression. All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care). All interventions will be provided by licensed physical therapists that are named as investigators in this study. | Other: Manual therapy<br>* Hip joint and spine manual therapy techniques applied toward the impairments of the subject.<br>Other: Education and advice<br>* All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care).<br>|
| Active Comparator: Education and exercise<br>Group will receive a prescriptive intervention designed to strengthen the hip and surrounding regions as well as improve flexibility of the lower extremity. This group will not receive additional physiotherapy management but will be schedule bi-weekly to review the home exercises and to receive appropriate educational support. All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care). All interventions will be provided by licensed physical therapists that are named as investigators in this study. | Other: Exercise<br>* Prescriptive exercise program of self-mobilization and/or strengthening program to address impairments of the subject.<br>Other: Education and advice<br>* All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care).<br>|
| Placebo Comparator: Supervised neglect<br>Group will receive supervised neglect. We will monitor this group for changes or emergent situations but no formal care will be provided. All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care). All interventions will be provided by licensed physical therapists that are named as investigators in this study. | Other: Education and advice<br>* All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care).<br>Other: Supervised neglect<br>* Monitoring of group without formal intervention.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Did subject elect to undergo surgery? | Determination of whether the subject had surgery for femoroacetabular impingement or not | up to 6 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Stanford Expectations of Treatment Scale (SETS) | subject expectation of treatment | initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit | 
| Change in Patient Acceptable Symptom State (PASS) | subject acceptance of what their current symptom state is | initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit | 
| Change in numeric pain rating scale |  | initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit | 
| Change in Hip and Groin Outcome Score |  | initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit | 
| Change in Single leg stance (SLS) | measure of single leg balance and stability | initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit | 
| Change in Lower Quarter Y Balance Test (YBT-LQ) | measure of single leg balance, strength and coordination | initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit | 
| Change in Single Leg Anteroposterior Hop | Measure of single leg balance, strength, power and coordination | initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit | 
| Change in Standing Hip Internal Rotation Range-of-Motion | Measure of single leg weight-bearing range of motion | initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit | 
| Change in Complications/Adverse Events of assigned treatment |  | initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit |