Fulfillment of Expectations for Patients With FAI Syndrome

June 18, 2019 updated by: Duke University

The Mediating Effect of Baseline Expectations of Conservative Care and Surgery Outcomes on Fulfillment of Expectations for Patients With Femoroacetabular Impingement Syndrome

A total of 63 participants will be recruited through 3 local surgeons in Durham, North Carolina after distinctive differential diagnostic methods, all with extensive expertise in intra-articular hip pathology and arthroscopy. The surgeons will offer the opportunity to participate in the trial by providing information to the recipient. Potential participants that do not contact project team members will be contacted by phone if they do not respond to the initial invitation. Potential participants will be initially screened by telephone interview, followed by a clinical examination to confirm study eligibility. The blinded researchers will obtain informed consent and will perform outcome assessments

Purpose of the Study: 1) measure the mediating effect of baseline patient expectations on fulfillment of expectations (for both conservative care and surgery, measured at 6 weeks and at 1 year respectively) in a cohort of patients with a diagnosis of FAI Syndrome who receive six weeks of conservative physical therapy intervention and 2) measure the effect of baseline expectations on patient reported outcomes (e.g., HAGOS, pain, global rating of change) at six weeks.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

FAI Syndrome is a morphological hip condition that can cause hip/groin pain and impaired performance.1 FAI Syndrome is caused by abnormal morphology of the femoral head (referred to as cam FAI Syndrome), excessive acetabular coverage of the femoral head (referred to as pincer FAI Syndrome) or a combination of the two (mixed FAI Syndrome).2 Not only can FAI Syndrome give rise to symptoms and impair function, the repetitive bony contact can also lead to a cascade of structural damage including tearing at the chondrolabral junction, full thickness cartilage delamination, and potentially hip osteoarthritis.

Presently, there is uncertainty involving the best treatment approach for symptomatic FAI Syndrome.2 The principal two management options are 1) physical therapy management of impairments and function and/or 2) surgery. Although presently, both modalities have been shown to improve symptoms in the short term,2 surgery is by far the most commonly incorporated approach.1, The incidence of the surgery has notably increased in recent years. There has been an 18-fold increase in surgical procedures for FAI Syndrome between 1999 and 2009, varying by geographic region in the USA.3

As an elective procedure, surgery for correction of FAI Syndrome is likely influenced by patients' perspectives and expectations of outcome.4 The extent to which these expectations influence specific treatment choices, as well as subsequent outcomes is currently unclear, although recent findings suggest that across various pathologies both patients5 and clinicians6 rarely have accurate expectations of treatment benefits or harms.

Non-operative, conservative treatments may have a role in managing FAI Syndrome to alleviate symptoms, potentially resulting in postponement or avoidance of surgery. Bony morphological changes can be present without symptoms, and nearly all participants with symptomatic FAI Syndrome undergo a variable asymptomatic period in the presence of structural FAI Syndrome. Recent studies have been hampered by retrospective and case cohort design, very small sample sizes, short-term follow up, and self-report measures only.4 A recent systematic review stated "although the available literature with experimental data is limited, there is a suggestion that physical therapy and activity modification confer some benefit to patients. Non-operative treatment regimens, particularly physical therapy, need to be evaluated more extensively and rigorously".6 Further, it is well known that patient expectations can mediate outcomes. Those who have high expectations about the potential benefit of the conservative approach are more likely to experience improvements. Conversely, those who have low expectations are more likely to fail to see improvement.

4. Design & Procedures: Reporting of the study will conform to STROBE guidelines for observational studies. The proposed study is a prospective case series:

1) Patients will receive:

  1. 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.
  2. Education on progression of exercise based on scientific exercise progression principle. Participants will be seen for 3 visits over 6 weeks (with weekly contact with the patient via email or phone call) and a final visit 1 year post-surgery for those electing to undergo surgery.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke Sports Science Institute
      • Durham, North Carolina, United States, 27703
        • Duke Orthopaedic Clinic Page Road
      • Durham, North Carolina, United States, 27710
        • Duke Orthopaedic Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Conservative care
Exercise and manual therapy
Other: Exercise

A prescription of progressive rehabilitation exercises designed to strengthen weakened muscle groups and stretch joint movements that demonstrate range of motion limitations will be provided as a home program. Treatment is based on clinical presentation and identification of impairments by the treating clinician. Participants will be seen for 3 visits over 6 weeks and a final visit 1 year post-surgery for those electing to undergo surgery.

The interventions will consist of progressive exercise (PE) in two phases with general instruction guidelines. The assigned program will be tailored per each participant's clinical presentation and progressed based on response to exercise load. The researcher will instruct, review and supervise each program initially and, at follow-up visits; as well as monitor progress, re-enforce treatment strategies and modify the respective program accordingly. Each participant will receive a home program manual as well as a program log.

Other: Manual Therapy
Hip joint and spine manual therapy techniques applied toward the impairments of the subject.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fulfillment of expectations with conservative care
Time Frame: 6 weeks post study initiation
fulfillment of expectations after conservative care implemented as by outcome questionnaire 'Fulfillment of expectations'
6 weeks post study initiation
Fulfillment of expectations with surgery
Time Frame: 1 year post-surgery
fulfillment of expectations after surgical care implemented as measured by 'Fulfillment of expectations' questionnaire
1 year post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS)
Time Frame: baseline, 6 weeks and 1 year post-surgery
patient expectations of care
baseline, 6 weeks and 1 year post-surgery
Expectations of conservative care
Time Frame: baseline
Expectations of conservative care as measured by expectation survey
baseline
Change in Expectations of surgery as measured by expectation survey
Time Frame: baseline and 6 weeks
baseline and 6 weeks
Change in Reasons for surgery
Time Frame: baseline and 6 weeks
patient reasons on why choosing surgery
baseline and 6 weeks
Change in Patient Acceptable Symptom State (PASS)
Time Frame: 6 weeks and 1 year post-surgery
PASS
6 weeks and 1 year post-surgery
Change in Numeric pain rating scale (NPRS)
Time Frame: baseline, 2 weeks, 6 weeks and 1 year
baseline, 2 weeks, 6 weeks and 1 year
Change in Global Rating of Change Score (GRoC)
Time Frame: 2 weeks, 6 weeks and 1 year post-surgery
GRoC
2 weeks, 6 weeks and 1 year post-surgery
Change in Hip and Groin Outcome Score (HAGOS)
Time Frame: baseline, 6 weeks and 1 year post-surgery
Patient reported outcome measure relative to hip and groin pain
baseline, 6 weeks and 1 year post-surgery
Change in Single Leg Squat (Maximum ROM until onset of pain)
Time Frame: baseline, 6 weeks and 1 year post-surgery
single leg squat performance
baseline, 6 weeks and 1 year post-surgery
Change in Bilateral Squat (Maximum ROM until onset of pain)
Time Frame: baseline, 6 weeks and 1 year post-surgery
bilateral leg squat performance
baseline, 6 weeks and 1 year post-surgery
Change in Tegner Activity Scale
Time Frame: baseline, 6 weeks and 1 year post-surgery
Tegner Activity Scale
baseline, 6 weeks and 1 year post-surgery
Change in Adverse events
Time Frame: baseline, 2 weeks, 6 weeks and 1 year post-surgery
any adverse events encountered
baseline, 2 weeks, 6 weeks and 1 year post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Michael Reiman, DPT, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 7, 2017

Primary Completion (ACTUAL)

July 31, 2018

Study Completion (ACTUAL)

July 31, 2018

Study Registration Dates

First Submitted

September 5, 2017

First Submitted That Met QC Criteria

September 7, 2017

First Posted (ACTUAL)

September 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 20, 2019

Last Update Submitted That Met QC Criteria

June 18, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00084795

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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