Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT05100394
Status:
COMPLETED
Last Update Posted:
2021-11-08
First Post:
2021-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Laser Therapy on Proximal Hamstring Tendinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D019220', 'term': 'High-Energy Shock Waves'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants and outcome assessor was unaware of allocation into experimental or control groups.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-arm parallel-groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-31', 'studyFirstSubmitDate': '2021-10-18', 'studyFirstSubmitQcDate': '2021-10-18', 'lastUpdatePostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numerical Pain Rating Scale', 'timeFrame': '3 weeks.', 'description': 'On a scale of 0-10, patients rate their current pain level. Higher scores mean worse outcome.'}, {'measure': 'Isokinetic peak torque', 'timeFrame': '3 weeks.', 'description': 'Isokinetic muscle power was measured.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Proximal hamstring tendinopathy', 'laser therapy', 'Pain', 'Muscle power'], 'conditions': ['Tendinopathy', 'Lasers']}, 'descriptionModule': {'briefSummary': "Proximal hamstring tendinopathy (PHT) is tendinopathy of the semimembranosus and/or biceps femoris/semitendinosus complex. Previous studies have shown the efficacy of laser therapy in the treatment of tendinopathy. To the best of the investigator's knowledge, no study has compared the effects of high-power LASER therapy with conventional physiotherapy programs in proximal hamstring tendinopathy patients. Therefore, this study aimed to assess the effects of high-power laser therapy on pain and muscle power in proximal hamstring tendinopathy patients.", 'detailedDescription': '2 arms comparative pretest-posttest experimental research design with random allocation of subjects into groups (experimental and control group) using the lottery method. A total of thirty-six participants aged between 18-35 (mean age) years, were recruited in the present study. The selected participants were randomly allocated into experimental and control groups using the lottery method and website randomization.com with eighteen participants in each group. The participants and outcome assessor were kept blinded to the allocation. In the experimental group, the high-power laser was given whereas in the control group conventional physiotherapy treatment was given for 4 weeks. Conventional physiotherapy treatment included the US, moist heat pack, and home exercises. Home exercises include nordic hamstring exercises - 2 sets of 5 repetitions, 3 days/week for 3 weeks.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Athletes\n* pain located deep in the buttock/posterior thigh region\n* tenderness of ischial tuberosity\n* hamstring muscle tightness.\n\nExclusion Criteria:\n\n* Recent trauma to the posterior thigh\n* Musculoskeletal disorder of ipsilateral lower extremity\n* taking pain medication daily\n* hypertension, malignancy, autoimmune disease, phlebitis, blood disorder.'}, 'identificationModule': {'nctId': 'NCT05100394', 'briefTitle': 'Effectiveness of Laser Therapy on Proximal Hamstring Tendinopathy', 'organization': {'class': 'OTHER', 'fullName': 'King Saud University'}, 'officialTitle': 'Effectiveness of High Power Laser Therapy on Pain and Isokinetic Power in Athletes With Proximal Hamstring Tendinopathy: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RRC-2021-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'High Power laser therapy was provided.', 'interventionNames': ['Radiation: Laser Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Conventional physiotherapy was applied including moist heat packs, US, and eccentric hamstring exercises.', 'interventionNames': ['Other: Ultrasound + Moist Heat pack + Exercises']}], 'interventions': [{'name': 'Laser Therapy', 'type': 'RADIATION', 'description': 'Therapeutic laser therapy was applied.', 'armGroupLabels': ['Experimental Group']}, {'name': 'Ultrasound + Moist Heat pack + Exercises', 'type': 'OTHER', 'description': 'Ultrasound therapy, a moist heat pack, and a home exercise program were given.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11433', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Saud University', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Masood Khan, MPTh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Saud University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Saud University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Masood Khan', 'investigatorAffiliation': 'King Saud University'}}}}