Clinical Trial: Conservative Intervention of Femoroacetabular Impingement Syndrome
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Conservative Intervention of Femoroacetabular Impingement Syndrome: A Randomized Controlled Trial
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'.
Detailed Summary:
Sponsor: Duke University
Current Primary Outcome: Did subject elect to undergo surgery? [ Time Frame: up to 6 months after intervention ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in Stanford Expectations of Treatment Scale (SETS) [ Time Frame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit ]subject expectation of treatment
- Change in Patient Acceptable Symptom State (PASS) [ Time Frame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit ]subject acceptance of what their current symptom state is
- Change in numeric pain rating scale [ Time Frame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit ]
- Change in Hip and Groin Outcome Score [ Time Frame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit ]
- Change in Single leg stance (SLS) [ Time Frame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit ]measure of single leg balance and stability
- Change in Lower Quarter Y Balance Test (YBT-LQ) [ Time Frame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit ]measure of single leg balance, strength and coordination
- Change in Single Leg Anteroposterior Hop [ Time Frame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit ]Measure of single leg balance, strength, power and coordination
- Change in Standing Hip Internal Rotation Range-of-Motion [ Time Frame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit ]Measure of single leg weight-bearing range of motion
- Change in Complications/Adverse Events of assigned treatment [ Time Frame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit ]
Original Secondary Outcome: Same as current
Information By: Duke University
Dates:
Date Received: March 8, 2016
Date Started: March 2016
Date Completion: March 2018
Last Updated: February 3, 2017
Last Verified: February 2016