Fulfillment of Expectations for Patients With FAI Syndrome

NCT03278353 | Terminated

• 1 other identifier: Pro00084795
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

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.

Conditions

Femoroacetabular Impingement

Keywords

Expectation; Conservative Intervention

Outcome Measures

Primary Outcomes (2)

• Fulfillment of expectations with conservative care

  fulfillment of expectations after conservative care implemented as by outcome questionnaire 'Fulfillment of expectations'

  6 weeks post study initiation

• Fulfillment of expectations with surgery

  fulfillment of expectations after surgical care implemented as measured by 'Fulfillment of expectations' questionnaire

  1 year post-surgery

Secondary Outcomes (12)

• Change in Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS)

  baseline, 6 weeks and 1 year post-surgery

• Expectations of conservative care

  baseline

• Change in Expectations of surgery as measured by expectation survey

  baseline and 6 weeks

• Change in Reasons for surgery

  baseline and 6 weeks

• Change in Patient Acceptable Symptom State (PASS)

  6 weeks and 1 year post-surgery

Study Arms (1)

Conservative care

EXPERIMENTAL

Exercise and manual therapy

Other: Exercise; Other: Manual Therapy

Interventions

Exercise OTHER

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.

Conservative care

Manual Therapy OTHER

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

Conservative care

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (3)

Duke Orthopaedic Clinic Page Road

Durham, North Carolina, 27703, United States

Location

Duke Sports Science Institute

Durham, North Carolina, 27705, United States

Location

Duke Orthopaedic Clinic

Durham, North Carolina, 27710, United States

Location

Related Publications (11)

• 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.

  PMID: 24067989 BACKGROUND

• 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.

  PMID: 15043095 BACKGROUND

• 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.

  PMID: 19261899 BACKGROUND

• 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.

  PMID: 26447703 BACKGROUND

• 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.

  PMID: 25246442 BACKGROUND

• 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.

  PMID: 25531451 BACKGROUND

• 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.

  PMID: 28097303 BACKGROUND

• 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.

  PMID: 24659505 BACKGROUND

• 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.

  PMID: 27245488 BACKGROUND

• 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.

  PMID: 21478502 BACKGROUND

• 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.

  PMID: 23419746 BACKGROUND

MeSH Terms

Conditions

Femoracetabular Impingement

Interventions

Exercise; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Michael Reiman, DPT

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cases series

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 11, 2017
• Study Start: November 7, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: June 20, 2019

Record last verified: 2019-06

Locations

US (3)