Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-29 @ 12:09 AM
Study NCT ID:
NCT04960150
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2021-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EFFECTS OF ACUPUNCTURE ON LEG MUSCLE STRENGTH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-07', 'studyFirstSubmitDate': '2021-06-23', 'studyFirstSubmitQcDate': '2021-07-12', 'lastUpdatePostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leg muscle strength', 'timeFrame': 'baseline (Before intervention)', 'description': 'Measurement of leg muscle strength before the intervention, and compared between the two groups'}, {'measure': 'Leg muscle strength', 'timeFrame': '35 minutes after intervention', 'description': 'Measurement of leg muscle strength after the intervention, and compared between the two groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acupuncture', 'press tack needle', 'leg strength'], 'conditions': ['Health, Subjective', 'Muscle Strength']}, 'descriptionModule': {'briefSummary': 'Press tack needle is one of the acupuncture modalities in the form of needles that are attached to the skin, and can be left attached to the skin for several days which makes its use much easier than conventional acupuncture.\n\nThe purpose of this study was to determine how the effect of press tack needle acupuncture on leg muscle strength performed on sports students.\n\nResearch subjects as many as 30 people were randomized into two groups, namely the intervention group and the control group. In the intervention group, acupuncture treatment was performed with a press tack needle at acupuncture points on the legs. The leg muscle strength was measured using a leg dynamometer before and after the acupuncture intervention. Analyzed the difference in mean leg muscle strength before and after the intervention, and between the two groups.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* willingness to fill out an informed consent form;\n* age between 18-25 years;\n* male;\n* has a BMI value of 18.5-22.9 kg/m2;\n* there is no history of injury or history of surgery on the lower extremities in the last three months;\n* the individual is in good health.\n\nExclusion Criteria:\n\n* absence or refusal to be examined and not cooperative.'}, 'identificationModule': {'nctId': 'NCT04960150', 'briefTitle': 'EFFECTS OF ACUPUNCTURE ON LEG MUSCLE STRENGTH', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'EFFECTS OF ACUPUNCTURE ON LEG MUSCLE STRENGTH: RANDOMIZED CONTROLLED TRIAL IN SPORTS STUDENTS', 'orgStudyIdInfo': {'id': '21-05-0541'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture group', 'description': 'Intervention of press tack needle acupuncture', 'interventionNames': ['Device: Press tack needle']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Intervention of placebo acupuncture', 'interventionNames': ['Device: Plesterin']}], 'interventions': [{'name': 'Press tack needle', 'type': 'DEVICE', 'description': 'Press tack needle acupuncture using "Seirin Pyonex" sized 0.20x1.2mm', 'armGroupLabels': ['Acupuncture group']}, {'name': 'Plesterin', 'type': 'DEVICE', 'description': 'Plesterin', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Sport Science Faculty, Universitas Negeri Jakarta', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Wahyuningsih Djaali', 'investigatorAffiliation': 'Indonesia University'}}}}