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Fulfillment of Expectations for Patients With FAI Syndrome

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ClinicalTrials.gov Identifier: NCT03278353
Recruitment Status : Terminated (Lack of enrollment)
First Posted : September 11, 2017
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE September 5, 2017
First Posted Date  ICMJE September 11, 2017
Last Update Posted Date June 20, 2019
Actual Study Start Date  ICMJE November 7, 2017
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2017)
  • 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'
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2017)
  • Change in Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS) [ Time Frame: baseline, 6 weeks and 1 year post-surgery ]
    patient expectations of care
  • Expectations of conservative care [ Time Frame: baseline ]
    Expectations of conservative care as measured by expectation survey
  • Change in Expectations of surgery as measured by expectation survey [ Time Frame: baseline and 6 weeks ]
  • Change in Reasons for surgery [ Time Frame: baseline and 6 weeks ]
    patient reasons on why choosing surgery
  • Change in Patient Acceptable Symptom State (PASS) [ Time Frame: 6 weeks and 1 year post-surgery ]
    PASS
  • Change in Numeric pain rating scale (NPRS) [ Time Frame: 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
  • 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
  • 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
  • Change in Bilateral Squat (Maximum ROM until onset of pain) [ Time Frame: baseline, 6 weeks and 1 year post-surgery ]
    bilateral leg squat performance
  • Change in Tegner Activity Scale [ Time Frame: baseline, 6 weeks and 1 year post-surgery ]
    Tegner Activity Scale
  • Change in Adverse events [ Time Frame: baseline, 2 weeks, 6 weeks and 1 year post-surgery ]
    any adverse events encountered
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2017)
  • Change in Stanford Expectations of Treatment Scale (SETS) [ Time Frame: baseline, 6 weeks and 1 year post-surgery ]
    patient expectations of care
  • Expectations of conservative care [ Time Frame: baseline ]
    Expectations of conservative care as measured by expectation survey
  • Change in Expectations of surgery as measured by expectation survey [ Time Frame: baseline and 6 weeks ]
  • Change in Reasons for surgery [ Time Frame: baseline and 6 weeks ]
    patient reasons on why choosing surgery
  • Change in Patient Acceptable Symptom State (PASS) [ Time Frame: 6 weeks and 1 year post-surgery ]
    PASS
  • Change in Numeric pain rating scale (NPRS) [ Time Frame: baseline, 6 weeks and 1 year ]
  • Change in Global Rating of Change Score (GRoC) [ Time Frame: 6 weeks and 1 year post-surgery ]
    GRoC
  • 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
  • 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
  • Change in Bilateral Squat (Maximum ROM until onset of pain) [ Time Frame: baseline, 6 weeks and 1 year post-surgery ]
    bilateral leg squat performance
  • Change in Tegner Activity Scale [ Time Frame: baseline, 6 weeks and 1 year post-surgery ]
    Tegner Activity Scale
  • Change in Adverse events [ Time Frame: baseline, 6 weeks and 1 year post-surgery ]
    any adverse events encountered
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fulfillment of Expectations for Patients With FAI Syndrome
Official Title  ICMJE The Mediating Effect of Baseline Expectations of Conservative Care and Surgery Outcomes on Fulfillment of Expectations for Patients With Femoroacetabular Impingement Syndrome
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective cases series
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Femoroacetabular Impingement
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: Conservative care
Exercise and manual therapy
Interventions:
  • Other: Exercise
  • Other: Manual Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 18, 2019)
6
Original Estimated Enrollment  ICMJE
 (submitted: September 7, 2017)
63
Actual Study Completion Date  ICMJE July 31, 2018
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03278353
Other Study ID Numbers  ICMJE Pro00084795
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Reiman, DPT Duke University
PRS Account Duke University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP