Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2026-01-12 @ 5:42 AM
Study NCT ID:
NCT02175316
Status:
COMPLETED
Last Update Posted:
2020-04-22
First Post:
2014-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhanced External Counterpulsation on Delayed Onset Muscle Soreness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-20', 'studyFirstSubmitDate': '2014-05-21', 'studyFirstSubmitQcDate': '2014-06-24', 'lastUpdatePostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in delayed onset muscle soreness over time.', 'timeFrame': 'At 3, 6, 9, 12, 15, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48 Hours', 'description': 'Likert pain surveys'}], 'secondaryOutcomes': [{'measure': 'Pain tolerance', 'timeFrame': 'Baseline, 24 hours, 2 days 3 days 4 days 33 days', 'description': 'Pain tolerance measured by mmHg pressure required to elicit a delayed-onset muscle pain response.'}, {'measure': 'Bio-markers for muscle inflammation', 'timeFrame': 'Baseline, 24 hours, 2 days 3 days 4 days 33 days', 'description': 'Bio-markers for muscle inflammation: C-reactive protein, creatine phosphokinase, and white blood cell count.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Muscle Tightness']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effects of Enhanced External Counterpulsation on delayed onset muscle soreness. The primary outcomes will be duration of delayed onset muscle soreness, WBC count, CRP count, CPK count, and pain tolerance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy active Duty or DoD beneficiaries between 25 and 59 years old\n\nExclusion Criteria:\n\n* Not on a physical profile\n* Not taking any OTC or prescription pain medications or workout supplements'}, 'identificationModule': {'nctId': 'NCT02175316', 'briefTitle': 'Enhanced External Counterpulsation on Delayed Onset Muscle Soreness', 'organization': {'class': 'FED', 'fullName': 'David Grant U.S. Air Force Medical Center'}, 'officialTitle': 'Effects of Enhanced External Counterpulsation on Delayed Onset Muscle Soreness, a Pilot Study', 'orgStudyIdInfo': {'id': 'FDG20130045H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: EECP for DOMS', 'description': 'All enrolled subjects will receive EECP treatment Delayed Onset Muscle Soreness.', 'interventionNames': ['Device: Enhanced External Counterpulsation']}], 'interventions': [{'name': 'Enhanced External Counterpulsation', 'type': 'DEVICE', 'otherNames': ['Lumenair Enhanced External Counterpulsation Therapy System, Vasomedical'], 'description': 'Enhanced External Counterpulsation', 'armGroupLabels': ['Experimental: EECP for DOMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94535', 'city': 'Travis Air Force Base', 'state': 'California', 'country': 'United States', 'facility': 'David Grant USAF Medical Center', 'geoPoint': {'lat': 38.26845, 'lon': -121.93373}}], 'overallOfficials': [{'name': 'Sachin Shah', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'United States Air Force'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'David Grant U.S. Air Force Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}