Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-24 @ 11:58 AM
Study NCT ID:
NCT05077761
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2021-10-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laser Therapy on Hamstring Muscle Among Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-09', 'studyFirstSubmitDate': '2021-10-01', 'studyFirstSubmitQcDate': '2021-10-01', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Active Knee Extension Test', 'timeFrame': 'Changes will be measured at baseline, end of two week post intervention', 'description': 'Active knee extension test (AKET) is most reliable method to assess the hamstring tightness.'}, {'measure': 'Sit and toe touch test', 'timeFrame': 'Changes will be measured at baseline, end of two week post intervention', 'description': 'Sit and toe touch test is used to assess the hamstring flexibility'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Flexibility', 'Hamstring', 'Laser therapy', 'Young adults'], 'conditions': ['Muscle Tightness']}, 'referencesModule': {'references': [{'pmid': '34444402', 'type': 'BACKGROUND', 'citation': 'Cejudo A, Centenera-Centenera JM, Santonja-Medina F. The Potential Role of Hamstring Extensibility on Sagittal Pelvic Tilt, Sagittal Spinal Curves and Recurrent Low Back Pain in Team Sports Players: A Gender Perspective Analysis. Int J Environ Res Public Health. 2021 Aug 16;18(16):8654. doi: 10.3390/ijerph18168654.'}, {'pmid': '9285439', 'type': 'BACKGROUND', 'citation': 'Jozwiak M, Pietrzak S, Tobjasz F. The epidemiology and clinical manifestations of hamstring muscle and plantar foot flexor shortening. Dev Med Child Neurol. 1997 Jul;39(7):481-3. doi: 10.1111/j.1469-8749.1997.tb07468.x.'}, {'pmid': '31991284', 'type': 'BACKGROUND', 'citation': 'Medeiros DM, Aimi M, Vaz MA, Baroni BM. Effects of low-level laser therapy on hamstring strain injury rehabilitation: A randomized controlled trial. Phys Ther Sport. 2020 Mar;42:124-130. doi: 10.1016/j.ptsp.2020.01.006. Epub 2020 Jan 10.'}, {'pmid': '30607719', 'type': 'BACKGROUND', 'citation': 'Dornelles MP, Fritsch CG, Sonda FC, Johnson DS, Leal-Junior ECP, Vaz MA, Baroni BM. Photobiomodulation therapy as a tool to prevent hamstring strain injuries by reducing soccer-induced fatigue on hamstring muscles. Lasers Med Sci. 2019 Aug;34(6):1177-1184. doi: 10.1007/s10103-018-02709-w. Epub 2019 Jan 3.'}, {'pmid': '28341795', 'type': 'BACKGROUND', 'citation': 'Hughes T, Callaghan M. BET 2: LASER THERAPY IN THE TREATMENT OF ACUTE HAMSTRING MUSCLE INJURIES. Emerg Med J. 2017 Apr;34(4):266. doi: 10.1136/emermed-2017-206665.2.'}, {'pmid': '28194375', 'type': 'BACKGROUND', 'citation': 'Ramos GA, Arliani GG, Astur DC, Pochini AC, Ejnisman B, Cohen M. Rehabilitation of hamstring muscle injuries: a literature review. Rev Bras Ortop. 2016 Dec 15;52(1):11-16. doi: 10.1016/j.rboe.2016.12.002. eCollection 2017 Jan-Feb.'}]}, 'descriptionModule': {'briefSummary': 'A total of 154 healthy young individuals will be recruited by purposive sampling method to participate in a randomized, single-blinded, sham-controlled study. Recruited participants will be randomly dividing into two groups, the Active high-intensity laser therapy (a-HILT) group, and the Sham high-intensity laser therapy (s-HILT) group. The treatment duration will be 10 minutes per session on both lower limbs for each day for 3 days/week for 2 weeks. Hamstring muscle length will be assessed at baseline, end of the 2-week post-intervention period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asymptomatic young adults\n* Both gender\n* Tightness of hamstring muscles\n\nExclusion Criteria:\n\n* Any other musculoskeletal disorder\n* Any disc pathology\n* Any nerve root irritation\n* Any surgical history or trauma\n* Malignancy\n* Pregnancy\n* Sensory dysfunctions\n* Cardiac pacemaker'}, 'identificationModule': {'nctId': 'NCT05077761', 'briefTitle': 'Laser Therapy on Hamstring Muscle Among Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'Maharishi Markendeswar University (Deemed to be University)'}, 'officialTitle': 'High-intensity Laser Therapy on Hamstring Muscle Length Among Young Adults', 'orgStudyIdInfo': {'id': 'U1111-1269-9595'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-intensity laser therapy', 'description': '77 participants will receive active high-intensity laser therapy interventions on hamstring muscle to improve the flexibility of muscle', 'interventionNames': ['Device: Active High-intensity laser therapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham High-intensity laser therapy', 'description': '77 participants will receive sham high-intensity laser therapy on hamstring muscle', 'interventionNames': ['Device: Sham High-intensity laser therapy']}], 'interventions': [{'name': 'Active High-intensity laser therapy', 'type': 'DEVICE', 'description': 'High-intensity laser therapy will be used in the contact method, with the laser beam irradiated over the hamstring muscle. Dosage and parameters for the laser will be calculated.\n\nParameters-\n\n1. Wavelength- 980 nm\n2. Intensity/Power density- 3W/cm2\n3. Emission mode- Continuous Emission\n4. Energy (Joules)- 490 J\n5. Irradiation time- 70 Sec on each point\n6. Peak power- 15 Watt\n7. Irradiation points- 09', 'armGroupLabels': ['High-intensity laser therapy']}, {'name': 'Sham High-intensity laser therapy', 'type': 'DEVICE', 'description': 'Sham High-intensity laser therapy will be used in the contact method, without the laser beam irradiation over the hamstring muscle.', 'armGroupLabels': ['Sham High-intensity laser therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '133207', 'city': 'Ambāla', 'state': 'Haryana', 'country': 'India', 'facility': 'Maharishi Markandeshwar (M.M) Hospital, Mullana, Ambala, Haryana', 'geoPoint': {'lat': 30.36099, 'lon': 76.79782}}], 'overallOfficials': [{'name': 'Adarsh K Srivastav, PhD Scholar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MMIPR, MM(DU)'}, {'name': 'Asir J Samuel, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MMIPR, MM(DU)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maharishi Markendeswar University (Deemed to be University)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Asir John Samuel', 'investigatorAffiliation': 'Maharishi Markendeswar University (Deemed to be University)'}}}}