Conservative Intervention of Femoroacetabular Impingement Syndrome

Conservative Intervention of Femoroacetabular Impingement Syndrome: A Randomized Controlled Trial

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'.

Study Overview

• Status: Withdrawn
• Conditions: Femoroacetabular Impingement
• Intervention / Treatment: Other: Manual therapy; Other: Education and advice; Other: Exercise; Other: Supervised neglect

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Education, exercise and manual therapy; 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; Hip joint and spine manual therapy techniques applied toward the impairments of the subject.; Other: Education and advice; All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care).
ACTIVE_COMPARATOR: Education and exercise; 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: Education and advice; All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care).; Other: Exercise; Prescriptive exercise program of self-mobilization and/or strengthening program to address impairments of the subject.
PLACEBO_COMPARATOR: Supervised neglect; 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; All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care).; Other: Supervised neglect; Monitoring of group without formal intervention.

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

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (ANTICIPATED): March 1, 2018
• Study Completion (ANTICIPATED): March 1, 2018

Study Registration Dates

• First Submitted: March 8, 2016
• First Submitted That Met QC Criteria: March 8, 2016
• First Posted (ESTIMATE): March 11, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): February 6, 2017
• Last Update Submitted That Met QC Criteria: February 3, 2017
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Femoracetabular Impingement
• Other Study ID Numbers: Pro00069234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO