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Conservative Intervention of Femoroacetabular Impingement Syndrome

Conservative Intervention of Femoroacetabular Impingement Syndrome: A Randomized Controlled Trial

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02706756
Enrollment
0
Registered
2016-03-11
Start date
2016-03-31
Completion date
2018-03-31
Last updated
2017-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoroacetabular Impingement

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'.

Interventions

OTHERExercise

Prescriptive exercise program of self-mobilization and/or strengthening program to address impairments of the subject.

OTHERManual therapy

Hip joint and spine manual therapy techniques applied toward the impairments of the subject.

All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care).

OTHERSupervised neglect

Monitoring of group without formal intervention.

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Did subject elect to undergo surgery?up to 6 months after interventionDetermination of whether the subject had surgery for femoroacetabular impingement or not

Secondary

MeasureTime frameDescription
Change in Patient Acceptable Symptom State (PASS)initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visitsubject acceptance of what their current symptom state is
Change in numeric pain rating scaleinitial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Change in Hip and Groin Outcome Scoreinitial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Change in Single leg stance (SLS)initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visitmeasure of single leg balance and stability
Change in Stanford Expectations of Treatment Scale (SETS)initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visitsubject expectation of treatment
Change in Single Leg Anteroposterior Hopinitial visit, 4 to 6 weeks after initial visit, and 6 months after initial visitMeasure of single leg balance, strength, power and coordination
Change in Standing Hip Internal Rotation Range-of-Motioninitial visit, 4 to 6 weeks after initial visit, and 6 months after initial visitMeasure of single leg weight-bearing range of motion
Change in Complications/Adverse Events of assigned treatmentinitial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Change in Lower Quarter Y Balance Test (YBT-LQ)initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visitmeasure of single leg balance, strength and coordination

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026