Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2026-02-13 @ 11:32 AM
Study NCT ID:
NCT02154893
Status:
COMPLETED
Last Update Posted:
2015-12-04
First Post:
2014-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Synergic Effects of Ultrasound and Laser on the Pain Relief and Functionality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D007834', 'term': 'Lasers'}, {'id': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-03', 'studyFirstSubmitDate': '2014-05-24', 'studyFirstSubmitQcDate': '2014-05-30', 'lastUpdatePostDateStruct': {'date': '2015-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of pain for hands and knees', 'timeFrame': '3 months', 'description': 'Pressure pain thresholds by algometry (N)'}], 'secondaryOutcomes': [{'measure': 'Subjective pain scale for hands and knees', 'timeFrame': '3 months', 'description': 'Pain intensity by visual analog scale (VAS)'}, {'measure': 'Jebsen-Taylor Hand Function Test', 'timeFrame': '3 months', 'description': 'The time (s) to perform different activities is registered'}, {'measure': 'Box and block Hand Function Test', 'timeFrame': '3 months', 'description': 'The number of wooden blocks that can be transported from one compartement of a box to another within 1 min is counted'}, {'measure': 'Toe-Touching Function Test', 'timeFrame': '3 months', 'description': 'The distance (cm) from the finger of hand to finger of foot is registered'}, {'measure': 'Sit-to-Stand Function Test', 'timeFrame': '3 months', 'description': 'The number of sit-to-stand within 1 min is counted'}, {'measure': 'Gait Function Test', 'timeFrame': '3 months', 'description': 'The time (s) to perform 10 meters walked is registered'}, {'measure': 'Balance Function Test', 'timeFrame': '3 months', 'description': 'The time (s) to perform static and dynamic balance is registered'}, {'measure': 'Dynamometry', 'timeFrame': '3 months', 'description': 'Strength (N)'}, {'measure': 'Accelerometer', 'timeFrame': '3 months', 'description': 'Acceleration (km.h-1)'}, {'measure': 'Electrogoniometry', 'timeFrame': '3 months', 'description': 'Range of motion (angle)'}, {'measure': 'Quality of life Questionnaire', 'timeFrame': '3 months', 'description': 'SF36'}, {'measure': 'Questionnaire for Osteoarthritis', 'timeFrame': '3 months', 'description': 'AUSCAN, WOMAC, KOOS, LEQUESNE index'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ultrasound', 'Laser', 'Therapeutic exercise', 'Rehabilitation', 'Osteoarthritis'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '15704096', 'type': 'RESULT', 'citation': 'Brosseau L, Wells G, Marchand S, Gaboury I, Stokes B, Morin M, Casimiro L, Yonge K, Tugwell P. Randomized controlled trial on low level laser therapy (LLLT) in the treatment of osteoarthritis (OA) of the hand. Lasers Surg Med. 2005 Mar;36(3):210-9. doi: 10.1002/lsm.20137.'}, {'pmid': '17629805', 'type': 'RESULT', 'citation': 'Ekim A, Armagan O, Tascioglu F, Oner C, Colak M. Effect of low level laser therapy in rheumatoid arthritis patients with carpal tunnel syndrome. Swiss Med Wkly. 2007 Jun 16;137(23-24):347-52. doi: 10.4414/smw.2007.11581.'}, {'pmid': '16616270', 'type': 'RESULT', 'citation': 'Allen RJ. Physical agents used in the management of chronic pain by physical therapists. Phys Med Rehabil Clin N Am. 2006 May;17(2):315-45. doi: 10.1016/j.pmr.2005.12.007.'}, {'pmid': '18853213', 'type': 'RESULT', 'citation': 'Korstjens CM, van der Rijt RH, Albers GH, Semeins CM, Klein-Nulend J. Low-intensity pulsed ultrasound affects human articular chondrocytes in vitro. Med Biol Eng Comput. 2008 Dec;46(12):1263-70. doi: 10.1007/s11517-008-0409-9. Epub 2008 Oct 14.'}, {'pmid': '20925995', 'type': 'RESULT', 'citation': 'Tascioglu F, Kuzgun S, Armagan O, Ogutler G. Short-term effectiveness of ultrasound therapy in knee osteoarthritis. J Int Med Res. 2010 Jul-Aug;38(4):1233-42. doi: 10.1177/147323001003800404.'}], 'seeAlsoLinks': [{'url': 'http://cepof.ifsc.usp.br/', 'label': 'Optics and Photonics Research Center'}]}, 'descriptionModule': {'briefSummary': 'There are several therapeutic effects of the ultrasound (US) or low level laser therapy (LLLT), including pain relief, increase of microcirculation, modulation of inflammatory response and accelerated tissue repair. The investigators hypothesis was that a combination of US, LLLT and therapeutic exercise may maximize clinical outcome.', 'detailedDescription': 'Patients with pain, especially chronic pain, avoid movements. This is turn results in a gradual impairment of their physical condition, reducing, for example, strength, flexibility, physical functionality and occupational activity. To performed physical treatments, a prototype device was development. The device includes four diode laser beams (808 nm) around of the one ultrasound transducer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caucasian women\n* Aged between 60 and 80 years\n* Hand osteoarthritis\n* Knee osteoarthritis\n\nExclusion Criteria:\n\n* Psychiatric disorder,\n* Neurological disease\n* Metabolic disease\n* Pulmonary disease\n* Cardiac disease,\n* Thrombosis\n* Cancer.'}, 'identificationModule': {'nctId': 'NCT02154893', 'briefTitle': 'Synergic Effects of Ultrasound and Laser on the Pain Relief and Functionality', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Synergic Effects of Ultrasound and Laser on the Pain Relief and Functionality in Women With Hand or Knee Osteoarthritis.', 'orgStudyIdInfo': {'id': 'FAPESP2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Device and exercise', 'description': 'Device with ultrasound and laser associated with therapeutic exercise', 'interventionNames': ['Device: Ultrasound plus Laser and therapeutic exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Device', 'description': 'Device with ultrasound and laser', 'interventionNames': ['Device: Ultrasound plus Laser']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Without any treatment', 'interventionNames': ['Device: Utrasound plus Laser Placebo']}], 'interventions': [{'name': 'Ultrasound plus Laser and therapeutic exercise', 'type': 'DEVICE', 'description': 'Ultrasound with frequency 1 Mhz and infrared laser with output power at 100 mW. The resistance training was performed.The treatments are done once a week, for 3 months.', 'armGroupLabels': ['Device and exercise']}, {'name': 'Ultrasound plus Laser', 'type': 'DEVICE', 'description': 'Ultrasound with frequency 1 Mhz and infrared laser with output power at 100 mW. The treatments are done once a week, for 3 months.', 'armGroupLabels': ['Device']}, {'name': 'Utrasound plus Laser Placebo', 'type': 'DEVICE', 'description': 'The device with Ultrasound and infrared laser without emitting electromagnetic or mechanical waves was applied (null dose).', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Carlos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Alessandra Rossi Paolillo', 'geoPoint': {'lat': -22.0175, 'lon': -47.89083}}], 'overallOfficials': [{'name': 'Vanderlei S Bagnato, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Physics Institute of São Carlos (IFSC), University of São Paulo (USP)'}, {'name': 'Alessandra R Paolillo, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Physics Institute of São Carlos (IFSC), University of São Paulo (USP)'}, {'name': 'Fernanda R Paolillo, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Physics Institute of São Carlos (IFSC), University of São Paulo (USP)'}, {'name': 'Jéssica João, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Physics Institute of São Carlos (IFSC), University of São Paulo (USP)'}, {'name': 'Herbert João, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Physics Institute of São Carlos (IFSC), University of São Paulo (USP)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}, {'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D', 'investigatorFullName': 'Fernanda Rossi Paolillo', 'investigatorAffiliation': 'University of Sao Paulo'}}}}