Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-01-04 @ 3:21 AM
Study NCT ID:
NCT02032758
Status:
COMPLETED
Last Update Posted:
2016-07-25
First Post:
2014-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Arm and Putter Movement in Golfers With Golfer's Cramp
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020821', 'term': 'Dystonic Disorders'}], 'ancestors': [{'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011433', 'term': 'Propranolol'}, {'id': 'D004576', 'term': 'Electromyography'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D009213', 'term': 'Myography'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cadler@mayo.edu', 'phone': '480-301-8100', 'title': 'Dr. Charles H. Adler', 'organization': 'Mayo Clinic in Arizona'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Participants were monitored for adverse events on the day of the study.', 'eventGroups': [{'id': 'EG000', 'title': "Golfers With Golfer's Cramp", 'description': 'Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Golf Pros', 'description': 'Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Dynamic Change of Rotation at Impact', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Golfers With Golfer's Cramp", 'description': 'Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.'}, {'id': 'OG001', 'title': 'Golf Pros', 'description': 'Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.'}], 'classes': [{'title': 'No propranolol', 'categories': [{'measurements': [{'value': '-38.4', 'spread': '26.1', 'groupId': 'OG000'}, {'value': '-32.5', 'spread': '9.8', 'groupId': 'OG001'}]}]}, {'title': 'After propranolol', 'categories': [{'measurements': [{'value': '-36.5', 'spread': '36.5', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The pro golfers did not take propranolol so they were only tested once, at baseline.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, approximately 45 minutes after propranolol dosing', 'description': '"Dynamic change of rotation at impact" is the velocity of rotation of the putter from the start of the forward swing until the time of impact with the golf ball.', 'unitOfMeasure': 'degrees/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "This variable was measured at baseline and then again approximately 45 minutes after propranolol in the group with golfer's cramp on the same day. The pro golfers did not take propranolol so they were only tested once, at baseline."}, {'type': 'SECONDARY', 'title': 'Mean Total Putter Face Rotation Before Impact', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Golfers With Golfer's Cramp", 'description': 'Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.'}, {'id': 'OG001', 'title': 'Golf Pros', 'description': 'Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.'}], 'classes': [{'title': 'No propranolol', 'categories': [{'measurements': [{'value': '3.3', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'After propranolol', 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.9', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The pro golfers did not take propranolol so they were only tested once, at baseline.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, approximately 45 minutes after propranolol dosing', 'description': '"Total putter face rotation before impact" is the degrees of rotation of the putter from the start of the forward swing until the time of impact with the golf ball.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "This variable was measured at baseline and then again approximately 45 minutes after propranolol in the group with golfer's cramp on the same day. The pro golfers did not take propranolol so they were only tested once, at baseline."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': "Golfers With Golfer's Cramp", 'description': 'Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.'}, {'id': 'FG001', 'title': 'Golf Pros', 'description': 'Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from Mayo Clinic in Arizona.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': "Golfers With Golfer's Cramp", 'description': 'Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.'}, {'id': 'BG001', 'title': 'Golf Pros', 'description': 'Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-10', 'studyFirstSubmitDate': '2014-01-02', 'resultsFirstSubmitDate': '2016-05-05', 'studyFirstSubmitQcDate': '2014-01-07', 'lastUpdatePostDateStruct': {'date': '2016-07-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-10', 'studyFirstPostDateStruct': {'date': '2014-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Dynamic Change of Rotation at Impact', 'timeFrame': 'baseline, approximately 45 minutes after propranolol dosing', 'description': '"Dynamic change of rotation at impact" is the velocity of rotation of the putter from the start of the forward swing until the time of impact with the golf ball.'}], 'secondaryOutcomes': [{'measure': 'Mean Total Putter Face Rotation Before Impact', 'timeFrame': 'baseline, approximately 45 minutes after propranolol dosing', 'description': '"Total putter face rotation before impact" is the degrees of rotation of the putter from the start of the forward swing until the time of impact with the golf ball.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Occupational; Cramp(s)'], 'conditions': ['Occupational; Cramp(s)']}, 'descriptionModule': {'briefSummary': 'The investigators will investigate golfers with visual evidence of an involuntary movement while putting before and after treatment with a low dose of propranolol.', 'detailedDescription': "Dystonia affecting athletes has received little research attention and there has been a lack of awareness or interest among both physicians and athletes. Task-specific dystonias or occupational cramps affect people while writing, typing, and or playing a musical instrument. Our group has previously shown that a subset of golfers who complain of the yips appear to have a task-specific dystonia or golfer's cramp. The yips are characterized by an inability to appropriately complete a golf stroke, most often putting and chipping strokes. Most individuals with the yips describe a jerking or shaking movement that interrupts their swing. In many cases the yips are disabling and the golfer, including professional tour players, give up golfing.\n\nGolfers who have evidence of golfer's cramp will putt a series of putts during which they will be monitored for arm movements and putter movements. They will then be treated with a low dose of propranolol to see if there is a change in these parameters."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria:\n\n* Age 18-75\n* Complaint of golfer's cramp/yips\n* Visual evidence of a movement disorder during putting\n* Able to complete 80 putts during the session\n\nExclusion criteria:\n\n* Contraindication to treatment with propranolol\n* Movement disorder not when putting"}, 'identificationModule': {'nctId': 'NCT02032758', 'briefTitle': "Study of Arm and Putter Movement in Golfers With Golfer's Cramp", 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': "Golfer's Cramp: Correlation of Wrist Movements and Surface EMG With Putter Movements", 'orgStudyIdInfo': {'id': '12-007930'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Golfers With Golfer's Cramp", 'description': 'Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.', 'interventionNames': ['Drug: Propranolol', 'Device: Opal Device', 'Procedure: Science and Motion PuttLab (SAM)', 'Device: Surface Electromyography EMG']}, {'type': 'OTHER', 'label': 'Golf Pros', 'description': 'Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.', 'interventionNames': ['Device: Opal Device', 'Procedure: Science and Motion PuttLab (SAM)', 'Device: Surface Electromyography EMG']}], 'interventions': [{'name': 'Propranolol', 'type': 'DRUG', 'otherNames': ['Inderal'], 'description': 'Single oral dose of 10 mg propranolol', 'armGroupLabels': ["Golfers With Golfer's Cramp"]}, {'name': 'Opal Device', 'type': 'DEVICE', 'description': 'The Opal Device (APDM, Inc.) will be used to measure wrist movement.', 'armGroupLabels': ['Golf Pros', "Golfers With Golfer's Cramp"]}, {'name': 'Science and Motion PuttLab (SAM)', 'type': 'PROCEDURE', 'description': 'The SAM will be used to study putter stroke movement and ball movement.', 'armGroupLabels': ['Golf Pros', "Golfers With Golfer's Cramp"]}, {'name': 'Surface Electromyography EMG', 'type': 'DEVICE', 'description': 'The surface EMG will be used to evaluate co-contraction of the wrist flexor/extensor muscle groups and the wrist pronator/supinator muscle groups.', 'armGroupLabels': ['Golf Pros', "Golfers With Golfer's Cramp"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Charles Adler, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurolgy', 'investigatorFullName': 'Charles Adler', 'investigatorAffiliation': 'Mayo Clinic'}}}}