Fulfillment of Expectations for Patients With FAI Syndrome
NCT ID: NCT03278353
Last Updated: 2019-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
6 participants
INTERVENTIONAL
2017-11-07
2018-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Conservative Intervention of Femoroacetabular Impingement Syndrome
NCT02706756
Arthroscopic Treatment of Patients in Horsens and Aarhus With FemoroAcetabular Impingement: the HAFAI-cohort
NCT02306525
Diagnosis and Treatment of Patients With Femoroacetabular Impingement Syndrome
NCT03846817
Conservative Management of Femoroacetabular Impingement
NCT01814124
First-line Treatment for Femoroacetabular Impingement Syndrome
NCT05927935
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Conservative care
Exercise and manual therapy
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.
Manual Therapy
Hip joint and spine manual therapy techniques applied toward the impairments of the subject.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Manual Therapy
Hip joint and spine manual therapy techniques applied toward the impairments of the subject.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Duke University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Reiman, DPT
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Duke Orthopaedic Clinic Page Road
Durham, North Carolina, United States
Duke Sports Science Institute
Durham, North Carolina, United States
Duke Orthopaedic Clinic
Durham, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00084795
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.