Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:17 PM
Study NCT ID:
NCT01390103
Status:
COMPLETED
Last Update Posted:
2013-04-22
First Post:
2011-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Do Hip Injections Improve Short-Term Biomechanical Outcomes In Patients With Hip Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-18', 'studyFirstSubmitDate': '2011-07-05', 'studyFirstSubmitQcDate': '2011-07-06', 'lastUpdatePostDateStruct': {'date': '2013-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the immediate biomechanical effect in patients that receive a hip injection.', 'timeFrame': 'The short-term biomechanical effects of the hip will be evaluated within 1 hour of the patient receiving the injection.', 'description': 'The biomechanical assessment of gait will consist of walking on a gait mat. The mat is a specialized pressure sensor system. Prior to data collection, each participant will walk across the mat three times for acclimation. The first assessment will include a walk at a self-selected, comfortable pace across the mat, repeated three times. The second assessment will include walking as quickly as possible, also repeated three times.'}], 'secondaryOutcomes': [{'measure': 'Oswestry Hip Pain Disability Questionnaire', 'timeFrame': 'Baseline, Within 1 hour of hip injection, 2 weeks post-injection', 'description': 'Oswestry Hip Pain Disability Questionnaire. This a standard, well validated questionnaire to assess disability caused by hip pain. The questionnaire is a 10-item scale, ranging from 0 to 100%, to obtain a score for functional disability caused by hip pain.'}, {'measure': 'Medical Outcomes Study (MOS) Short-Form Health Survey (SF-12)', 'timeFrame': 'Baseline, Within 1 hour of injection, 2 weeks post-injection', 'description': 'The SF-12 is a global health assessment questionnaire ranging from 0 to 100%, to score self-experienced health related to quality of life. Items are grouped into two domains from which an overall summary score, a physical component score and a mental component score can be derived. A high score on each of the scales reflects a high level of self-experienced health'}, {'measure': '10 centimeter Visual Analog Scale (VAS)', 'timeFrame': 'Baseline, Within 1 hour of injection, 2 weeks post-injection', 'description': 'Hip pain is a symptom that affects the overall Quality Of Life. Hip pain intensity will be self-assessed by a 10 cm visual analogue scale with terminal descriptors (anchors of 0 cm = no pain; 10 cm = worst possible pain). The VAS is an accepted outcome measure for chronic pain conditions.'}, {'measure': 'Pain Provocative Maneuvers', 'timeFrame': 'Baseline, Within 1 hour of injection, 2 weeks pos-injection', 'description': 'All patients currently undergoing hip injections receive a basic physical exam including patient specific provocative maneuvers both before and after the injection. The loss of pain after injection of a local anesthetic is part of the routine treatment algorithm and the results will be correlated with other outcome measures'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hip pain'], 'conditions': ['Hip Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to determine the effect of hip injections on hip biomechanics in patients with hip pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Potential subjects will be all patients receiving a hip injection for hip pain.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Osteoarthritis patients with hip pain requiring hip injection\n* Receiving hip injection\n* BMI \\< 35\n\nExclusion Criteria:\n\n* BMI \\> 35\n* severely impaired intellectual capacity\n* dementia, or other neurodegenerative diseases that would preclude appropriate cognitive or physical ability to perform study protocol'}, 'identificationModule': {'nctId': 'NCT01390103', 'briefTitle': 'Do Hip Injections Improve Short-Term Biomechanical Outcomes In Patients With Hip Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Do Hip Injections Improve Short-Term Biomechanical Outcomes In Patients With Hip Pain', 'orgStudyIdInfo': {'id': '711-2010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Assessment following the hip injection', 'description': 'Assessment to evaluate the effect of the hip injection on biomechanics.', 'interventionNames': ['Other: Assessment following hip injection']}], 'interventions': [{'name': 'Assessment following hip injection', 'type': 'OTHER', 'description': 'Assessment to evaluate the effect of the hip injection on biomechanics.', 'armGroupLabels': ['Assessment following the hip injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF&Shands Orthopaedics and Sports Medicine Institute', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'MaryBeth Horodyski, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Florida Departmen of Orthopaedics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}