Viewing Study NCT03241095


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Study NCT ID: NCT03241095
Status: COMPLETED
Last Update Posted: 2020-07-17
First Post: 2017-07-27
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: The Efficacy of Osteopathic Manipulative Treatment (OMT) on the Golf Swing
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D026301', 'term': 'Manipulation, Osteopathic'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-15', 'studyFirstSubmitDate': '2017-07-27', 'studyFirstSubmitQcDate': '2017-08-04', 'lastUpdatePostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Strength of golf swing as measured by the carry distance (the distance the ball flies in the air)', 'timeFrame': '30 minutes', 'description': "The participant will perform 10 swings into a golf simulator using a 5 iron. The simulator will record the information for each swing. Measurements include: Club head speed (Mph), Ball speed (Mph), Launch angle (Deg), Azimuth (Deg), Side spin (Rpm), Back spin (Rpm), Total spin (Rpm), Descent angle (Deg), Carry (Yds),Total distance (Yds), Offline (Yds), Peak height (Yds). We will be looking at the 'Carry' variable, before and after the intervention."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteopathic Manipulation Treatment', 'Golf'], 'conditions': ['Manipulation, Osteopathic']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate if osteopathic manipulative treatment (OTM) improves the golf swing of the participants. Study participants will be randomized into three groups, we will stratify by age and gender to make them as uniform as possible. One group will receive no intervention other than a 10-minute break between the pre and post measurements. A second group will receive a sham intervention where the doctor will pretend to give the participant OTM. The third group will receive real OTM.\n\nParticipants will perform a sample of 10 golf swings pre and post intervention which will be measured by a golf simulator. They will also complete a brief health history and pre/post self-evaluation of their swing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Adult golfers (18 years old or over) -\n\nExclusion Criteria: Anyone under 18 years, people that do not golf.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03241095', 'briefTitle': 'The Efficacy of Osteopathic Manipulative Treatment (OMT) on the Golf Swing', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'The Efficacy of Osteopathic Manipulative Treatment (OMT) on the Swing Via Objective Data From Golf Simulator Swing Analysis and Subjective Data', 'orgStudyIdInfo': {'id': 'FMCH-2017-25925'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control'}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham OMT', 'interventionNames': ['Procedure: Sham intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OMT', 'interventionNames': ['Procedure: OMT (Osteopathic Manipulative Treatment)']}], 'interventions': [{'name': 'OMT (Osteopathic Manipulative Treatment)', 'type': 'PROCEDURE', 'description': 'The co-hort will receive OMT. Each participant will perform 10 swings golf swings to determine a baseline measure the strength of their golf swing. This co-hort will then be evaluated by the physician and be given OMT.', 'armGroupLabels': ['OMT']}, {'name': 'Sham intervention', 'type': 'PROCEDURE', 'description': 'The co-hort participants will each perform 10 swings golf swings to determine a baseline measure the strength of their golf swing. Theythen be given a sham OMT procedure.', 'armGroupLabels': ['Sham OMT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56001', 'city': 'Mankato', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Health System - Family Medicine Clinic', 'geoPoint': {'lat': 44.15906, 'lon': -94.00915}}], 'overallOfficials': [{'name': 'Angela Buffington, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}