Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-29 @ 12:08 PM
Study NCT ID:
NCT04864704
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
2021-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Decrease of Muscle Biomechanical Stiffness Following Dry Needling in Asymptomatic Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079245', 'term': 'Dry Needling'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2015-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-25', 'studyFirstSubmitDate': '2021-04-20', 'studyFirstSubmitQcDate': '2021-04-25', 'lastUpdatePostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Stiffness', 'timeFrame': 'Change from baseline and immediately post intervention', 'description': 'Biomechanical stiffness of the muscle measured, non-invasively using a MyotonPRO. Stiffness (N/m)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '60 healthy participants were randomized into infraspinatus, erector spinae, or gastrocnemius groups. One session of dry needling DN was applied to the muscle in standardized location. Stiffness was assessed using a MyotonPRO at baseline, immediately post DN, and 24 hours later. The presence of a localized twitch response (LTR) during DN was used to subgroup participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men and women ages 18 to 65 years\n* reported good general health\n* tenderness or palpable trigger point in the muscle (infraspinatus, gastrocnemius, or erector spinae)\n\nExclusion Criteria:\n\n* BMI \\> 30kg/m2\n* surgery in the prior 12 months\n* current pain in the shoulder, low back, and lower leg\n* precautions to dry needling treatment (anticoagulant medications, bleeding disorders, known pregnancy)'}, 'identificationModule': {'nctId': 'NCT04864704', 'briefTitle': 'Immediate Decrease of Muscle Biomechanical Stiffness Following Dry Needling in Asymptomatic Participants', 'organization': {'class': 'OTHER', 'fullName': 'Bradley University'}, 'officialTitle': 'Immediate Decrease of Muscle Biomechanical Stiffness Following Dry Needling in Asymptomatic Participants', 'orgStudyIdInfo': {'id': 'BradleyU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Infraspinatus', 'description': 'Subjects infraspinatus stiffness was measured and observed', 'interventionNames': ['Other: dry needling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Erector spinae', 'description': 'Subjects erector spinae stiffness was measured and observed', 'interventionNames': ['Other: dry needling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gastrocnemius', 'description': 'Subjects gastrocnemius stiffness was measured and observed', 'interventionNames': ['Other: dry needling']}], 'interventions': [{'name': 'dry needling', 'type': 'OTHER', 'description': 'Physical therapy', 'armGroupLabels': ['Erector spinae', 'Gastrocnemius', 'Infraspinatus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61625', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Bradley University', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bradley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Joseph Kelly', 'investigatorAffiliation': 'Bradley University'}}}}