Conservative Intervention of Femoroacetabular Impingement Syndrome

NCT ID: NCT02706756

Last Updated: 2017-02-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-03-31

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'.

Conditions

Femoroacetabular Impingement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Manual therapy

Intervention Type: OTHER

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

Education and advice

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: OTHER

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

Education and advice

Intervention Type: OTHER

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

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.

Group Type: PLACEBO_COMPARATOR

Education and advice

Intervention Type: OTHER

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

Supervised neglect

Intervention Type: OTHER

Monitoring of group without formal intervention.

Interventions

Manual therapy

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

Intervention Type: OTHER

Exercise

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

Intervention Type: OTHER

Education and advice

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

Intervention Type: OTHER

Supervised neglect

Monitoring of group without formal intervention.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Pro00069234

Identifier Type: -

Identifier Source: org_study_id