<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03278353</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00084795</org_study_id>
    <nct_id>NCT03278353</nct_id>
  </id_info>
  <brief_title>Fulfillment of Expectations for Patients With FAI Syndrome</brief_title>
  <official_title>The Mediating Effect of Baseline Expectations of Conservative Care and Surgery Outcomes on Fulfillment of Expectations for Patients With Femoroacetabular Impingement Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A total of 63 participants will be recruited through 3 local surgeons in Durham, North&#xD;
      Carolina after distinctive differential diagnostic methods, all with extensive expertise in&#xD;
      intra-articular hip pathology and arthroscopy. The surgeons will offer the opportunity to&#xD;
      participate in the trial by providing information to the recipient. Potential participants&#xD;
      that do not contact project team members will be contacted by phone if they do not respond to&#xD;
      the initial invitation. Potential participants will be initially screened by telephone&#xD;
      interview, followed by a clinical examination to confirm study eligibility. The blinded&#xD;
      researchers will obtain informed consent and will perform outcome assessments&#xD;
&#xD;
      Purpose of the Study: 1) measure the mediating effect of baseline patient expectations on&#xD;
      fulfillment of expectations (for both conservative care and surgery, measured at 6 weeks and&#xD;
      at 1 year respectively) in a cohort of patients with a diagnosis of FAI Syndrome who receive&#xD;
      six weeks of conservative physical therapy intervention and 2) measure the effect of baseline&#xD;
      expectations on patient reported outcomes (e.g., HAGOS, pain, global rating of change) at six&#xD;
      weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      FAI Syndrome is a morphological hip condition that can cause hip/groin pain and impaired&#xD;
      performance.1 FAI Syndrome is caused by abnormal morphology of the femoral head (referred to&#xD;
      as cam FAI Syndrome), excessive acetabular coverage of the femoral head (referred to as&#xD;
      pincer FAI Syndrome) or a combination of the two (mixed FAI Syndrome).2 Not only can FAI&#xD;
      Syndrome give rise to symptoms and impair function, the repetitive bony contact can also lead&#xD;
      to a cascade of structural damage including tearing at the chondrolabral junction, full&#xD;
      thickness cartilage delamination, and potentially hip osteoarthritis.&#xD;
&#xD;
      Presently, there is uncertainty involving the best treatment approach for symptomatic FAI&#xD;
      Syndrome.2 The principal two management options are 1) physical therapy management of&#xD;
      impairments and function and/or 2) surgery. Although presently, both modalities have been&#xD;
      shown to improve symptoms in the short term,2 surgery is by far the most commonly&#xD;
      incorporated approach.1, The incidence of the surgery has notably increased in recent years.&#xD;
      There has been an 18-fold increase in surgical procedures for FAI Syndrome between 1999 and&#xD;
      2009, varying by geographic region in the USA.3&#xD;
&#xD;
      As an elective procedure, surgery for correction of FAI Syndrome is likely influenced by&#xD;
      patients' perspectives and expectations of outcome.4 The extent to which these expectations&#xD;
      influence specific treatment choices, as well as subsequent outcomes is currently unclear,&#xD;
      although recent findings suggest that across various pathologies both patients5 and&#xD;
      clinicians6 rarely have accurate expectations of treatment benefits or harms.&#xD;
&#xD;
      Non-operative, conservative treatments may have a role in managing FAI Syndrome to alleviate&#xD;
      symptoms, potentially resulting in postponement or avoidance of surgery. Bony morphological&#xD;
      changes can be present without symptoms, and nearly all participants with symptomatic FAI&#xD;
      Syndrome undergo a variable asymptomatic period in the presence of structural FAI Syndrome.&#xD;
      Recent studies have been hampered by retrospective and case cohort design, very small sample&#xD;
      sizes, short-term follow up, and self-report measures only.4 A recent systematic review&#xD;
      stated &quot;although the available literature with experimental data is limited, there is a&#xD;
      suggestion that physical therapy and activity modification confer some benefit to patients.&#xD;
      Non-operative treatment regimens, particularly physical therapy, need to be evaluated more&#xD;
      extensively and rigorously&quot;.6 Further, it is well known that patient expectations can mediate&#xD;
      outcomes. Those who have high expectations about the potential benefit of the conservative&#xD;
      approach are more likely to experience improvements. Conversely, those who have low&#xD;
      expectations are more likely to fail to see improvement.&#xD;
&#xD;
      4. Design &amp; Procedures: Reporting of the study will conform to STROBE guidelines for&#xD;
      observational studies. The proposed study is a prospective case series:&#xD;
&#xD;
      1) Patients will receive:&#xD;
&#xD;
        1. A prescription of progressive rehabilitation exercises designed to strengthen weakened&#xD;
           muscle groups and stretch joint movements that demonstrate range of motion limitations.&#xD;
           Treatment is based on clinical presentation and identification of impairments by the&#xD;
           treating clinician.&#xD;
&#xD;
        2. Education on progression of exercise based on scientific exercise progression principle.&#xD;
           Participants will be seen for 3 visits over 6 weeks (with weekly contact with the&#xD;
           patient via email or phone call) and a final visit 1 year post-surgery for those&#xD;
           electing to undergo surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">November 7, 2017</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Prospective cases series</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fulfillment of expectations with conservative care</measure>
    <time_frame>6 weeks post study initiation</time_frame>
    <description>fulfillment of expectations after conservative care implemented as by outcome questionnaire 'Fulfillment of expectations'</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fulfillment of expectations with surgery</measure>
    <time_frame>1 year post-surgery</time_frame>
    <description>fulfillment of expectations after surgical care implemented as measured by 'Fulfillment of expectations' questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS)</measure>
    <time_frame>baseline, 6 weeks and 1 year post-surgery</time_frame>
    <description>patient expectations of care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expectations of conservative care</measure>
    <time_frame>baseline</time_frame>
    <description>Expectations of conservative care as measured by expectation survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Expectations of surgery as measured by expectation survey</measure>
    <time_frame>baseline and 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Reasons for surgery</measure>
    <time_frame>baseline and 6 weeks</time_frame>
    <description>patient reasons on why choosing surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Acceptable Symptom State (PASS)</measure>
    <time_frame>6 weeks and 1 year post-surgery</time_frame>
    <description>PASS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Numeric pain rating scale (NPRS)</measure>
    <time_frame>baseline, 2 weeks, 6 weeks and 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Global Rating of Change Score (GRoC)</measure>
    <time_frame>2 weeks, 6 weeks and 1 year post-surgery</time_frame>
    <description>GRoC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hip and Groin Outcome Score (HAGOS)</measure>
    <time_frame>baseline, 6 weeks and 1 year post-surgery</time_frame>
    <description>Patient reported outcome measure relative to hip and groin pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Single Leg Squat (Maximum ROM until onset of pain)</measure>
    <time_frame>baseline, 6 weeks and 1 year post-surgery</time_frame>
    <description>single leg squat performance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Bilateral Squat (Maximum ROM until onset of pain)</measure>
    <time_frame>baseline, 6 weeks and 1 year post-surgery</time_frame>
    <description>bilateral leg squat performance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Tegner Activity Scale</measure>
    <time_frame>baseline, 6 weeks and 1 year post-surgery</time_frame>
    <description>Tegner Activity Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Adverse events</measure>
    <time_frame>baseline, 2 weeks, 6 weeks and 1 year post-surgery</time_frame>
    <description>any adverse events encountered</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Femoroacetabular Impingement</condition>
  <arm_group>
    <arm_group_label>Conservative care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise and manual therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <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.&#xD;
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.</description>
    <arm_group_label>Conservative care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual Therapy</intervention_name>
    <description>Hip joint and spine manual therapy techniques applied toward the impairments of the subject.</description>
    <arm_group_label>Conservative care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals age 18 to 60 years,&#xD;
&#xD;
          -  diagnosed with FAI by an orthopedic surgeon and exhibiting&#xD;
&#xD;
          -  hip/groin symptoms for at least 3 months (symptomatic); and&#xD;
&#xD;
          -  signs, symptoms and imaging findings conducive to FAI will be recruited from a&#xD;
             surgical practice of an orthopedic surgeon in Durham, North Carolina.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects that have radiographic evidence of hip osteoarthritis that is more than mild&#xD;
             in severity defined as Tonnis &gt;grade 1 or Kellgren-Lawrence &gt;2;&#xD;
&#xD;
          -  have other concurrent injury/conditions that will affect their ability to participate&#xD;
             in the rehabilitation program and/or assessment procedures;&#xD;
&#xD;
          -  exhibit hip dysplasia (center edge angle &lt;20 degrees on AP radiograph&#xD;
&#xD;
          -  are unable to attend a study physiotherapist or participate in the rehabilitation&#xD;
             program if randomized to the PT group;&#xD;
&#xD;
          -  are unable to understand English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Reiman, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke Orthopaedic Clinic Page Road</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Sports Science Institute</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Orthopaedic Clinic</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>24067989</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>15043095</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19261899</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26447703</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25246442</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25531451</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>28097303</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24659505</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>27245488</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21478502</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23419746</PMID>
  </reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>June 18, 2019</last_update_submitted>
  <last_update_submitted_qc>June 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Expectation</keyword>
  <keyword>Conservative Intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Femoracetabular Impingement</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03278353
org study id: Pro00084795
nct id: NCT03278353
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective cases series
primary purpose: Other
masking: None (Open Label)
measure: Fulfillment of expectations with conservative care
time frame: 6 weeks post study initiation
description: fulfillment of expectations after conservative care implemented as by outcome questionnaire 'Fulfillment of expectations'
measure: Fulfillment of expectations with surgery
time frame: 1 year post-surgery
description: fulfillment of expectations after surgical care implemented as measured by 'Fulfillment of expectations' questionnaire
measure: Change in Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS)
time frame: baseline, 6 weeks and 1 year post-surgery
description: patient expectations of care
measure: Expectations of conservative care
time frame: baseline
description: Expectations of conservative care as measured by expectation survey
measure: Change in Expectations of surgery as measured by expectation survey
time frame: baseline and 6 weeks
measure: Change in Reasons for surgery
time frame: baseline and 6 weeks
description: patient reasons on why choosing surgery
measure: Change in Patient Acceptable Symptom State (PASS)
time frame: 6 weeks and 1 year post-surgery
description: PASS
measure: Change in Numeric pain rating scale (NPRS)
time frame: baseline, 2 weeks, 6 weeks and 1 year
measure: Change in Global Rating of Change Score (GRoC)
time frame: 2 weeks, 6 weeks and 1 year post-surgery
description: GRoC
measure: Change in Hip and Groin Outcome Score (HAGOS)
time frame: baseline, 6 weeks and 1 year post-surgery
description: Patient reported outcome measure relative to hip and groin pain
measure: Change in Single Leg Squat (Maximum ROM until onset of pain)
time frame: baseline, 6 weeks and 1 year post-surgery
description: single leg squat performance
measure: Change in Bilateral Squat (Maximum ROM until onset of pain)
time frame: baseline, 6 weeks and 1 year post-surgery
description: bilateral leg squat performance
measure: Change in Tegner Activity Scale
time frame: baseline, 6 weeks and 1 year post-surgery
description: Tegner Activity Scale
measure: Change in Adverse events
time frame: baseline, 2 weeks, 6 weeks and 1 year post-surgery
description: any adverse events encountered
arm group label: Conservative care
arm group type: Experimental
description: Exercise and manual therapy
intervention type: Other
intervention name: Exercise
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.
arm group label: Conservative care
intervention type: Other
intervention name: Manual Therapy
description: Hip joint and spine manual therapy techniques applied toward the impairments of the subject.
arm group label: Conservative care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Michael Reiman, DPT
role: Principal Investigator
affiliation: Duke University
facility: 
facility: 
facility: 
country: United States
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.
PMID: 24067989
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.
PMID: 15043095
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responsible party type: Sponsor
mesh term: Femoracetabular Impingement
sharing ipd: Undecided