Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2026-01-25 @ 12:02 AM
Study NCT ID:
NCT02813395
Status:
COMPLETED
Last Update Posted:
2016-06-27
First Post:
2016-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser Therapy on Neuromuscular Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-24', 'studyFirstSubmitDate': '2016-06-21', 'studyFirstSubmitQcDate': '2016-06-24', 'lastUpdatePostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak torque normalized by body weight', 'timeFrame': 'Change from baseline to one hour.'}]}, 'conditionsModule': {'conditions': ['Fatigue']}, 'descriptionModule': {'briefSummary': 'Objective: Investigating the immediate effects of Low Level Laser Therapy (LLLT) on neuromuscular performance in healthy subjects after an induced muscle fatigue protocol. Methods: Eighty volunteers of both genders aged between 18 and 28 years underwent a preliminary evaluation using surface electromyography and isokinetic dynamometer of the flexor muscles of the elbow. The subjects were randomly allocated into 4 groups: G1 was control group; G2 placebo; G3 laser applied before fatigue protocol; and G4 immediately after. Muscular fatigue protocol consisted of 30 maximal concentric isokinetic contractions at 120°/s of the elbow flexor muscles. An 808 nm equipment was used for applying laser therapy, with a power of 100 mW and total energy of 20 J. Volunteers were reassessed after interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '28 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between 18-28 years of age, having no pain in the shoulder area, elbow or hand, and not having suffered any to injury to the assessed upper limb in the last six months.\n\nExclusion Criteria:\n\n* Presenting pain that prevented the completion of the evaluation, subjects whose data were improperly recorded or if the volunteer withdrew from the study.'}, 'identificationModule': {'nctId': 'NCT02813395', 'briefTitle': 'Laser Therapy on Neuromuscular Performance', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Rio Grande do Norte'}, 'officialTitle': 'Immediate Effects of Low-level Laser Therapy (808nm) on Neuromuscular Performance After Muscle Fatigue: Randomized-blinded Clinical Trial', 'orgStudyIdInfo': {'id': 'RMV2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Volunteers remained at rest before and after the fatigue protocol.'}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Volunteers were subjected to laser application simulation for approximately four minutes with a second pen of the laser device, which was disconnected and did not effectively irradiate energy.', 'interventionNames': ['Device: Placebo Laser']}, {'type': 'EXPERIMENTAL', 'label': 'Laser before', 'description': 'Volunteers received effective application of laser before fatigue protocol.', 'interventionNames': ['Device: Low Level Laser Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Laser after', 'description': 'Volunteers received effective application of laser after fatigue protocol.', 'interventionNames': ['Device: Low Level Laser Therapy']}], 'interventions': [{'name': 'Low Level Laser Therapy', 'type': 'DEVICE', 'description': 'Low Level Laser Therapy was applied at four points to the dominant upper limb of the volunteers on the muscle belly of the biceps. Delineation was done using a measuring tape from the elbow joint line to the acromion marked at points corresponding to 20%, 30%, 40% and 50% of this distance, focusing the application on the muscle belly region, thereby excluding the tendinous region.\n\nAn 808 nm equipment was used for applying laser therapy, with a power of 100 mW and total energy of 20 J.', 'armGroupLabels': ['Laser after', 'Laser before']}, {'name': 'Placebo Laser', 'type': 'DEVICE', 'description': 'Laser application simulation with a second pen of the laser device, which was disconnected and did not effectively irradiate energy.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59140-840', 'city': 'Natal', 'state': 'Rio Grande do Norte', 'country': 'Brazil', 'facility': 'Federal University of Rio Grande do Norte', 'geoPoint': {'lat': -5.795, 'lon': -35.20944}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Rio Grande do Norte', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Jamilson Simões Brasileiro', 'investigatorAffiliation': 'Universidade Federal do Rio Grande do Norte'}}}}