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Study Status: Withdrawn
Recruit Status: Withdrawn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:

  1. Purpose: 1) compare three conservative treatment approaches for subjects with femoroacetabular impingement syndrome (FAI), and 2) analyze functional outcome comparatively across groups.
  2. 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)
  3. 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 ]

Determination of whether the subject had surgery for femoroacetabular impingement or not


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