Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2026-03-03 @ 6:29 AM
Study NCT ID:
NCT02706756
Status:
WITHDRAWN
Last Update Posted:
2017-02-06
First Post:
2016-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conservative Intervention of Femoroacetabular Impingement Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057925', 'term': 'Femoracetabular Impingement'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Similar studies already published by other researchers', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-03', 'studyFirstSubmitDate': '2016-03-08', 'studyFirstSubmitQcDate': '2016-03-08', 'lastUpdatePostDateStruct': {'date': '2017-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Did subject elect to undergo surgery?', 'timeFrame': 'up to 6 months after intervention', 'description': 'Determination of whether the subject had surgery for femoroacetabular impingement or not'}], 'secondaryOutcomes': [{'measure': 'Change in Stanford Expectations of Treatment Scale (SETS)', 'timeFrame': 'initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit', 'description': 'subject expectation of treatment'}, {'measure': 'Change in Patient Acceptable Symptom State (PASS)', 'timeFrame': 'initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit', 'description': 'subject acceptance of what their current symptom state is'}, {'measure': 'Change in numeric pain rating scale', 'timeFrame': 'initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit'}, {'measure': 'Change in Hip and Groin Outcome Score', 'timeFrame': 'initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit'}, {'measure': 'Change in Single leg stance (SLS)', 'timeFrame': 'initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit', 'description': 'measure of single leg balance and stability'}, {'measure': 'Change in Lower Quarter Y Balance Test (YBT-LQ)', 'timeFrame': 'initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit', 'description': 'measure of single leg balance, strength and coordination'}, {'measure': 'Change in Single Leg Anteroposterior Hop', 'timeFrame': 'initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit', 'description': 'Measure of single leg balance, strength, power and coordination'}, {'measure': 'Change in Standing Hip Internal Rotation Range-of-Motion', 'timeFrame': 'initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit', 'description': 'Measure of single leg weight-bearing range of motion'}, {'measure': 'Change in Complications/Adverse Events of assigned treatment', 'timeFrame': 'initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Femoroacetabular Impingement']}, 'descriptionModule': {'briefSummary': "1. Purpose: 1) compare three conservative treatment approaches for subjects with femoroacetabular impingement syndrome (FAI), and 2) analyze functional outcome comparatively across groups.\n2. Interventions will be provided based on randomized assignment. Group 1 will receive treatment based on identified impairments and treated twice weekly to address said impairments with hip manual therapy and exercise, as well as a prescriptive exercise for strengthening and mobility of the hip. Group 2 will receive only the prescriptive exercise program. Group 3 will be a control group (supervised neglect)\n3. Primary outcomes data analysis will involve a mixed design (repeated measures) ANOVA for assessment of the primary outcome measure of the HAGOS. Secondary analyses will include chi square analyses (PASS, surgery at 6 months, adverse events), ANCOVA (PPMs, and expectations measures), or other appropriate comparative measures. None of the proposed treatment is considered outside of 'standard of practice'."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals age 18 to 60 years,\n* diagnosed with FAI by an orthopedic surgeon and exhibiting\n* hip/groin symptoms for at least 3 months (symptomatic); and\n* signs, symptoms and imaging findings conducive to FAI will be recruited from a surgical practice of an orthopedic surgeon in Durham, North Carolina.\n\nExclusion Criteria:\n\n* subjects that have radiographic evidence of hip osteoarthritis that is more than mild in severity defined as Tonnis \\>grade 1 or Kellgren-Lawrence \\>2;\n* have other concurrent injury/conditions that will affect their ability to participate in the rehabilitation program and/or assessment procedures;\n* exhibit hip dysplasia (center edge angle \\<20 degrees on AP radiograph\n* are unable to attend a study physiotherapist or participate in the rehabilitation program if randomized to the PT group;\n* are unable to understand English.'}, 'identificationModule': {'nctId': 'NCT02706756', 'briefTitle': 'Conservative Intervention of Femoroacetabular Impingement Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Conservative Intervention of Femoroacetabular Impingement Syndrome: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Pro00069234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Education, exercise and manual therapy', 'description': 'One group will receive education and advice, manual therapy that is applied toward the impairments of the subject, 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. Subjects will be seen twice weekly for 4 to 6 weeks, depending on the progression.\n\nAll three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care). All interventions will be provided by licensed physical therapists that are named as investigators in this study.', 'interventionNames': ['Other: Manual therapy', 'Other: Education and advice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Education and exercise', 'description': 'Group will receive a prescriptive intervention designed to strengthen the hip and surrounding regions as well as improve flexibility of the lower extremity. This group will not receive additional physiotherapy management but will be schedule bi-weekly to review the home exercises and to receive appropriate educational support.\n\nAll three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care). All interventions will be provided by licensed physical therapists that are named as investigators in this study.', 'interventionNames': ['Other: Exercise', 'Other: Education and advice']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Supervised neglect', 'description': 'Group will receive supervised neglect. We will monitor this group for changes or emergent situations but no formal care will be provided.\n\nAll three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care). All interventions will be provided by licensed physical therapists that are named as investigators in this study.', 'interventionNames': ['Other: Education and advice', 'Other: Supervised neglect']}], 'interventions': [{'name': 'Manual therapy', 'type': 'OTHER', 'description': 'Hip joint and spine manual therapy techniques applied toward the impairments of the subject.', 'armGroupLabels': ['Education, exercise and manual therapy']}, {'name': 'Exercise', 'type': 'OTHER', 'description': 'Prescriptive exercise program of self-mobilization and/or strengthening program to address impairments of the subject.', 'armGroupLabels': ['Education and exercise']}, {'name': 'Education and advice', 'type': 'OTHER', 'description': 'All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care).', 'armGroupLabels': ['Education and exercise', 'Education, exercise and manual therapy', 'Supervised neglect']}, {'name': 'Supervised neglect', 'type': 'OTHER', 'description': 'Monitoring of group without formal intervention.', 'armGroupLabels': ['Supervised neglect']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}