Femoroacetabular ImpingementNCT03278353
Fulfillment of Expectations for Patients With FAI Syndrome
A study testing Exercise and Manual Therapy in people with Femoroacetabular Impingement, run by Duke University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Femoroacetabular Impingement
- What is being tested?
- Exercise and Manual Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Nov 2017to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Duke Orthopaedic Clinic Page Road
Durham, North Carolina, 27703
Duke Sports Science Institute
Durham, North Carolina, 27705
Duke Orthopaedic Clinic
Durham, North Carolina, 27710
About this study
Official title: 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.
Read the 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.
- Design \& Procedures: Reporting of the study will conform to STROBE guidelines for observational studies. The proposed study is a prospective case series:
- 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.
- Conditions
- Femoroacetabular Impingement
- Being tested
- Exercise, Manual Therapy
- Keywords
- Expectation, Conservative Intervention
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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 TherapyOther
Hip joint and spine manual therapy techniques applied toward the impairments of the subject.
| Study group | Role | What they receive |
|---|---|---|
| Conservative care | Experimental | Exercise and manual therapy Receives: Other: Exercise; Other: Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fulfillment of expectations with conservative care
fulfillment of expectations after conservative care implemented as by outcome questionnaire 'Fulfillment of expectations'
Measured: 6 weeks post study initiation
Fulfillment of expectations with surgery
fulfillment of expectations after surgical care implemented as measured by 'Fulfillment of expectations' questionnaire
Measured: 1 year post-surgery
Secondary outcomes (12)
Change in Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS)
patient expectations of care
Measured: baseline, 6 weeks and 1 year post-surgery
Expectations of conservative care
Expectations of conservative care as measured by expectation survey
Measured: baseline
Change in Expectations of surgery as measured by expectation survey
Measured: baseline and 6 weeks
Change in Reasons for surgery
patient reasons on why choosing surgery
Measured: baseline and 6 weeks
Change in Patient Acceptable Symptom State (PASS)
PASS
Measured: 6 weeks and 1 year post-surgery
Change in Numeric pain rating scale (NPRS)
Measured: baseline, 2 weeks, 6 weeks and 1 year
Change in Global Rating of Change Score (GRoC)
GRoC
Measured: 2 weeks, 6 weeks and 1 year post-surgery
Change in Hip and Groin Outcome Score (HAGOS)
Patient reported outcome measure relative to hip and groin pain
Measured: baseline, 6 weeks and 1 year post-surgery
Change in Single Leg Squat (Maximum ROM until onset of pain)
single leg squat performance
Measured: baseline, 6 weeks and 1 year post-surgery
Change in Bilateral Squat (Maximum ROM until onset of pain)
bilateral leg squat performance
Measured: baseline, 6 weeks and 1 year post-surgery
Change in Tegner Activity Scale
Tegner Activity Scale
Measured: baseline, 6 weeks and 1 year post-surgery
Change in Adverse events
any adverse events encountered
Measured: baseline, 2 weeks, 6 weeks and 1 year post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start7 Nov 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cases series
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Reiman, DPT, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278353
- Sponsor's protocol ID
- Pro00084795
- Status last verified
- Jun 2019
- First submitted
- 5 Sep 2017
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24067989Beck 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.
PubMed 15043095Briggs 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.
PubMed 19261899Cormier 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.
PubMed 26447703Diamond 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.
PubMed 25246442Hoffmann 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.
PubMed 25531451Hoffmann 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.
PubMed 28097303Kemp 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.
PubMed 24659505Reiman 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.
PubMed 27245488Thorborg 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.
PubMed 21478502Wall 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.
PubMed 23419746
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mediating Effect of Baseline Expectations of Conservative Care and Surgery Outcomes on Fulfillment of Expectations for Patients With Femoroacetabular Impingement Syndrome
- ClinicalTrials.gov ID
- NCT03278353
- Acronym / sponsor ID
- Pro00084795
- Conditions
- Femoroacetabular Impingement
- Keywords
- Expectation, Conservative Intervention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 11 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Design \& Procedures: Reporting of the study will conform to STROBE guidelines for observational studies. The proposed study is a prospective case series:
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cases series
| Arm | Type | Receives |
|---|---|---|
| Conservative care | Experimental | Other: Exercise, Other: Manual TherapyExercise and manual therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseA 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 | Conservative care |
| Manual TherapyHip joint and spine manual therapy techniques applied toward the impairments of the subject. | Other | Conservative care |
Primary outcome
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
12 secondary outcomes
Change in Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS)
Time frame: baseline, 6 weeks and 1 year post-surgery
Expectations of conservative care
Time frame: baseline
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
Change in Patient Acceptable Symptom State (PASS)
Time frame: 6 weeks and 1 year post-surgery
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
Change in Hip and Groin Outcome Score (HAGOS)
Time frame: 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
Change in Bilateral Squat (Maximum ROM until onset of pain)
Time frame: baseline, 6 weeks and 1 year post-surgery
Change in Tegner Activity Scale
Time frame: baseline, 6 weeks and 1 year post-surgery
Change in Adverse events
Time frame: baseline, 2 weeks, 6 weeks and 1 year post-surgery
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Background: PubMed 24067989Ayeni 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.
- Background: PubMed 15043095Beck 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.
- Background: PubMed 19261899Briggs 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.
- Background: PubMed 26447703Cormier 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.
- Background: PubMed 25246442Diamond 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.
- Background: PubMed 25531451Hoffmann 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.
- Background: PubMed 28097303Hoffmann 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.
- Background: PubMed 24659505Kemp 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.
- Background: PubMed 27245488Reiman 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.
- Background: PubMed 21478502Thorborg 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.
- Background: PubMed 23419746Wall 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Reiman, DPT principal investigator
Duke University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Manual Therapy in people with Femoroacetabular Impingement, run by Duke University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fulfillment of expectations with conservative care (time frame: 6 weeks post study initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03278353, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.