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Fulfillment of Expectations for Patients With FAI Syndrome

Primary Purpose

Femoroacetabular Impingement

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Manual Therapy
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Femoroacetabular Impingement focused on measuring Expectation, Conservative Intervention

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

  • Duke Orthopaedic Clinic Page Road
  • Duke Sports Science Institute
  • Duke Orthopaedic Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Conservative care

Arm Description

Exercise and manual therapy

Outcomes

Primary Outcome Measures

Fulfillment of expectations with conservative care
fulfillment of expectations after conservative care implemented as by outcome questionnaire 'Fulfillment of expectations'
Fulfillment of expectations with surgery
fulfillment of expectations after surgical care implemented as measured by 'Fulfillment of expectations' questionnaire

Secondary Outcome Measures

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

Full Information

First Posted
September 5, 2017
Last Updated
June 18, 2019
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03278353
Brief Title
Fulfillment of Expectations for Patients With FAI Syndrome
Official Title
The Mediating Effect of Baseline Expectations of Conservative Care and Surgery Outcomes on Fulfillment of Expectations for Patients With Femoroacetabular Impingement Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
November 7, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoroacetabular Impingement
Keywords
Expectation, Conservative Intervention

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective cases series
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conservative care
Arm Type
Experimental
Arm Description
Exercise and manual therapy
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
Hip joint and spine manual therapy techniques applied toward the impairments of the subject.
Primary Outcome Measure Information:
Title
Fulfillment of expectations with conservative care
Description
fulfillment of expectations after conservative care implemented as by outcome questionnaire 'Fulfillment of expectations'
Time Frame
6 weeks post study initiation
Title
Fulfillment of expectations with surgery
Description
fulfillment of expectations after surgical care implemented as measured by 'Fulfillment of expectations' questionnaire
Time Frame
1 year post-surgery
Secondary Outcome Measure Information:
Title
Change in Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS)
Description
patient expectations of care
Time Frame
baseline, 6 weeks and 1 year post-surgery
Title
Expectations of conservative care
Description
Expectations of conservative care as measured by expectation survey
Time Frame
baseline
Title
Change in Expectations of surgery as measured by expectation survey
Time Frame
baseline and 6 weeks
Title
Change in Reasons for surgery
Description
patient reasons on why choosing surgery
Time Frame
baseline and 6 weeks
Title
Change in Patient Acceptable Symptom State (PASS)
Description
PASS
Time Frame
6 weeks and 1 year post-surgery
Title
Change in Numeric pain rating scale (NPRS)
Time Frame
baseline, 2 weeks, 6 weeks and 1 year
Title
Change in Global Rating of Change Score (GRoC)
Description
GRoC
Time Frame
2 weeks, 6 weeks and 1 year post-surgery
Title
Change in Hip and Groin Outcome Score (HAGOS)
Description
Patient reported outcome measure relative to hip and groin pain
Time Frame
baseline, 6 weeks and 1 year post-surgery
Title
Change in Single Leg Squat (Maximum ROM until onset of pain)
Description
single leg squat performance
Time Frame
baseline, 6 weeks and 1 year post-surgery
Title
Change in Bilateral Squat (Maximum ROM until onset of pain)
Description
bilateral leg squat performance
Time Frame
baseline, 6 weeks and 1 year post-surgery
Title
Change in Tegner Activity Scale
Description
Tegner Activity Scale
Time Frame
baseline, 6 weeks and 1 year post-surgery
Title
Change in Adverse events
Description
any adverse events encountered
Time Frame
baseline, 2 weeks, 6 weeks and 1 year post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Reiman, DPT
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Orthopaedic Clinic Page Road
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27703
Country
United States
Facility Name
Duke Sports Science Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke Orthopaedic Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24067989
Citation
Ayeni O, Chu R, Hetaimish B, Nur L, Simunovic N, Farrokhyar F, Bedi A, Bhandari M. A painful squat test provides limited diagnostic utility in CAM-type femoroacetabular impingement. Knee Surg Sports Traumatol Arthrosc. 2014 Apr;22(4):806-11. doi: 10.1007/s00167-013-2668-8. Epub 2013 Sep 26.
Results Reference
background
PubMed Identifier
15043095
Citation
Beck M, Leunig M, Parvizi J, Boutier V, Wyss D, Ganz R. Anterior femoroacetabular impingement: part II. Midterm results of surgical treatment. Clin Orthop Relat Res. 2004 Jan;(418):67-73.
Results Reference
background
PubMed Identifier
19261899
Citation
Briggs KK, Lysholm J, Tegner Y, Rodkey WG, Kocher MS, Steadman JR. The reliability, validity, and responsiveness of the Lysholm score and Tegner activity scale for anterior cruciate ligament injuries of the knee: 25 years later. Am J Sports Med. 2009 May;37(5):890-7. doi: 10.1177/0363546508330143. Epub 2009 Mar 4.
Results Reference
background
PubMed Identifier
26447703
Citation
Cormier S, Lavigne GL, Choiniere M, Rainville P. Expectations predict chronic pain treatment outcomes. Pain. 2016 Feb;157(2):329-338. doi: 10.1097/j.pain.0000000000000379.
Results Reference
background
PubMed Identifier
25246442
Citation
Diamond LE, Dobson FL, Bennell KL, Wrigley TV, Hodges PW, Hinman RS. Physical impairments and activity limitations in people with femoroacetabular impingement: a systematic review. Br J Sports Med. 2015 Feb;49(4):230-42. doi: 10.1136/bjsports-2013-093340. Epub 2014 Sep 22.
Results Reference
background
PubMed Identifier
25531451
Citation
Hoffmann TC, Del Mar C. Patients' expectations of the benefits and harms of treatments, screening, and tests: a systematic review. JAMA Intern Med. 2015 Feb;175(2):274-86. doi: 10.1001/jamainternmed.2014.6016.
Results Reference
background
PubMed Identifier
28097303
Citation
Hoffmann TC, Del Mar C. Clinicians' Expectations of the Benefits and Harms of Treatments, Screening, and Tests: A Systematic Review. JAMA Intern Med. 2017 Mar 1;177(3):407-419. doi: 10.1001/jamainternmed.2016.8254.
Results Reference
background
PubMed Identifier
24659505
Citation
Kemp JL, Makdissi M, Schache AG, Pritchard MG, Pollard TC, Crossley KM. Hip chondropathy at arthroscopy: prevalence and relationship to labral pathology, femoroacetabular impingement and patient-reported outcomes. Br J Sports Med. 2014 Jul;48(14):1102-7. doi: 10.1136/bjsports-2013-093312. Epub 2014 Mar 21.
Results Reference
background
PubMed Identifier
27245488
Citation
Reiman MP, Thorborg K, Holmich P. Femoroacetabular Impingement Surgery Is on the Rise-But What Is the Next Step? J Orthop Sports Phys Ther. 2016 Jun;46(6):406-8. doi: 10.2519/jospt.2016.0605.
Results Reference
background
PubMed Identifier
21478502
Citation
Thorborg K, Holmich P, Christensen R, Petersen J, Roos EM. The Copenhagen Hip and Groin Outcome Score (HAGOS): development and validation according to the COSMIN checklist. Br J Sports Med. 2011 May;45(6):478-91. doi: 10.1136/bjsm.2010.080937. Erratum In: Br J Sports Med. 2011 Jul;45(9):742.
Results Reference
background
PubMed Identifier
23419746
Citation
Wall PD, Fernandez M, Griffin DR, Foster NE. Nonoperative treatment for femoroacetabular impingement: a systematic review of the literature. PM R. 2013 May;5(5):418-26. doi: 10.1016/j.pmrj.2013.02.005. Epub 2013 Feb 16.
Results Reference
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Fulfillment of Expectations for Patients With FAI Syndrome

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