Conservative Intervention of Femoroacetabular Impingement Syndrome

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Primary Purpose

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Manual therapy

Exercise

Education and advice

Supervised neglect

About this trial

This is an interventional treatment trial for Femoroacetabular Impingement

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Education, exercise and manual therapy

Education and exercise

Supervised neglect

Arm Description

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 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 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.

Outcomes

Primary Outcome Measures

Did subject elect to undergo surgery?

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

Secondary Outcome Measures

Change in Stanford Expectations of Treatment Scale (SETS)

subject expectation of treatment

Change in Patient Acceptable Symptom State (PASS)

subject acceptance of what their current symptom state is

Change in numeric pain rating scale

Change in Hip and Groin Outcome Score

Change in Single leg stance (SLS)

measure of single leg balance and stability

Change in Lower Quarter Y Balance Test (YBT-LQ)

measure of single leg balance, strength and coordination

Change in Single Leg Anteroposterior Hop

Measure of single leg balance, strength, power and coordination

Change in Standing Hip Internal Rotation Range-of-Motion

Measure of single leg weight-bearing range of motion

Change in Complications/Adverse Events of assigned treatment

Full Information

NCT ID

NCT02706756

First Posted

March 8, 2016

Last Updated

February 3, 2017

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT02706756

Brief Title

Conservative Intervention of Femoroacetabular Impingement Syndrome

Official Title

Conservative Intervention of Femoroacetabular Impingement Syndrome: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Withdrawn

Why Stopped

Similar studies already published by other researchers

Study Start Date

March 2016 (undefined)

Primary Completion Date

March 2018 (Anticipated)

Study Completion Date

March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Femoroacetabular Impingement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Education, exercise and manual therapy

Arm Type

Experimental

Arm Description

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.

Arm Title

Education and exercise

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Supervised neglect

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Manual therapy

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Exercise

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Education and advice

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Supervised neglect

Intervention Description

Monitoring of group without formal intervention.

Primary Outcome Measure Information:

Title

Did subject elect to undergo surgery?

Description

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

Time Frame

up to 6 months after intervention

Secondary Outcome Measure Information:

Title

Change in Stanford Expectations of Treatment Scale (SETS)

Description

subject expectation of treatment

Time Frame