Clinical trial NCT02706756: Conservative Intervention of Femoroacetabular Impingement Syndrome
Official title: Conservative Intervention of Femoroacetabular Impingement Syndrome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Femoroacetabular Impingement
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-03-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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'.


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.

Primary outcomes:
measure: Did subject elect to undergo surgery?
timeFrame: up to 6 months after intervention
Secondary outcomes:
measure: Change in Stanford Expectations of Treatment Scale (SETS)
timeFrame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
measure: Change in Patient Acceptable Symptom State (PASS)
timeFrame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
measure: Change in numeric pain rating scale
timeFrame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
measure: Change in Hip and Groin Outcome Score
timeFrame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
measure: Change in Single leg stance (SLS)
timeFrame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
measure: Change in Lower Quarter Y Balance Test (YBT-LQ)
timeFrame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
measure: Change in Single Leg Anteroposterior Hop
timeFrame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
measure: Change in Standing Hip Internal Rotation Range-of-Motion
timeFrame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
measure: Change in Complications/Adverse Events of assigned treatment
timeFrame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Other outcomes:
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