Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT07057869
Status:
COMPLETED
Last Update Posted:
2025-07-10
First Post:
2025-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound Duration Effects on Knee Osteoarthritis Pain and Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This study is an open-label trial where both patients and treating physiotherapists are aware of the ultrasound treatment duration. Outcome assessors are blinded to group assignments to reduce assessment bias.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized controlled trial where 60 patients with knee osteoarthritis are randomly assigned to three groups receiving ultrasound therapy for 5, 10, or 15 minutes respectively. All groups receive conventional treatment alongside ultrasound therapy. The effects on pain and physical function are evaluated before and after a 4-week treatment period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2025-06-30', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity (VAS)', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Assessment of knee pain intensity using the Visual Analog Scale (VAS) at baseline and after 4 weeks of treatment.'}, {'measure': 'Physical Function (WOMAC)', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Evaluation of physical function and stiffness using the WOMAC index at baseline and after 4 weeks of treatment.'}], 'secondaryOutcomes': [{'measure': 'Walking Distance (2-Min Walk)', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Distance covered in 2 minutes walking test at baseline and after 4 weeks of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee Osteoarthritis, Ultrasound Therapy, Pain Management, Physical Function'], 'conditions': ['Knee Osteoarthristis']}, 'referencesModule': {'references': [{'pmid': '18338277', 'type': 'RESULT', 'citation': 'Eyigor S, Karapolat H, Ibisoglu U, Durmaz B. [Does transcutaneous electrical nerve stimulation or therapeutic ultrasound increase the effectiveness of exercise for knee osteoarthritis: a randomized controlled study]. Agri. 2008 Jan;20(1):32-40. Turkish.'}, {'pmid': '22412194', 'type': 'RESULT', 'citation': 'Paget C, Chow MT, Duret H, Mattarollo SR, Smyth MJ. Role of gammadelta T cells in alpha-galactosylceramide-mediated immunity. J Immunol. 2012 Apr 15;188(8):3928-39. doi: 10.4049/jimmunol.1103582. Epub 2012 Mar 12.'}, {'pmid': '20091539', 'type': 'RESULT', 'citation': 'Rutjes AW, Nuesch E, Sterchi R, Juni P. Therapeutic ultrasound for osteoarthritis of the knee or hip. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD003132. doi: 10.1002/14651858.CD003132.pub2.'}, {'pmid': '16084806', 'type': 'RESULT', 'citation': 'Huang MH, Lin YS, Lee CL, Yang RC. Use of ultrasound to increase effectiveness of isokinetic exercise for knee osteoarthritis. Arch Phys Med Rehabil. 2005 Aug;86(8):1545-51. doi: 10.1016/j.apmr.2005.02.007.'}, {'pmid': '18496246', 'type': 'RESULT', 'citation': 'Cetin N, Aytar A, Atalay A, Akman MN. Comparing hot pack, short-wave diathermy, ultrasound, and TENS on isokinetic strength, pain, and functional status of women with osteoarthritic knees: a single-blind, randomized, controlled trial. Am J Phys Med Rehabil. 2008 Jun;87(6):443-51. doi: 10.1097/PHM.0b013e318174e467.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effects of different ultrasound treatment durations on pain and physical function in patients with knee osteoarthritis. Sixty sedentary volunteers aged 18-85 with diagnosed knee osteoarthritis will be randomly assigned to three groups receiving ultrasound therapy for 5, 10, or 15 minutes, respectively, alongside conventional treatment. Pain and physical function will be assessed using the Visual Analog Scale (VAS), WOMAC Osteoarthritis Index, and 2-minute walk test at baseline and after 4 weeks of treatment. The results will help determine the optimal ultrasound treatment duration for improving symptoms in knee osteoarthritis patients.', 'detailedDescription': 'This clinical trial investigates the effects of different ultrasound therapy durations on pain relief and physical function improvement in patients with knee osteoarthritis. Sixty sedentary individuals aged 18 to 85 years diagnosed with knee osteoarthritis will be enrolled and randomly assigned to three groups receiving ultrasound treatment for 5, 10, or 15 minutes, respectively, alongside conventional therapy (such as hot packs, TENS, etc.).\n\nUltrasound therapy will be applied by a qualified physiotherapist at 1 W/cm² intensity and 1 MHz frequency in pulsed mode, for four weeks. Evaluations will be conducted at baseline and after treatment completion, using the Visual Analog Scale (VAS) for pain assessment, WOMAC Osteoarthritis Index for physical function, and a 2-minute walk test to measure walking performance.\n\nThis study aims to provide scientific evidence on the optimal ultrasound treatment duration for knee osteoarthritis, contributing to improved rehabilitation protocols. The findings will be prepared for publication in an international peer-reviewed journal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIndividuals aged between 18 and 85 years Diagnosed with knee osteoarthritis Recommended for ultrasound therapy as part of routine physical therapy Willing to participate voluntarily and provide written informed consent\n\nExclusion Criteria:\n\nHistory of acute knee trauma Individuals with contraindications to ultrasound therapy'}, 'identificationModule': {'nctId': 'NCT07057869', 'briefTitle': 'Ultrasound Duration Effects on Knee Osteoarthritis Pain and Function', 'organization': {'class': 'OTHER', 'fullName': 'KTO Karatay University'}, 'officialTitle': 'Comparison of the Effects of Different Ultrasound Treatment Durations on Pain and Physical Function in Patients With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'KaratayMST-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5-minute Ultrasound Group', 'description': 'Patients receive 5 minutes of pulsed ultrasound therapy (1 W/cm², 1 MHz) alongside conventional treatment for 4 weeks.', 'interventionNames': ['Procedure: 5-minute Ultrasound Group']}, {'type': 'EXPERIMENTAL', 'label': '10-minute Ultrasound Group', 'description': 'Patients receive 10 minutes of pulsed ultrasound therapy (1 W/cm², 1 MHz) alongside conventional treatment for 4 weeks.', 'interventionNames': ['Procedure: 10-minute Ultrasound Group']}, {'type': 'EXPERIMENTAL', 'label': '15-minute Ultrasound Group', 'description': 'Patients receive 15 minutes of pulsed ultrasound therapy (1 W/cm², 1 MHz) alongside conventional treatment for 4 weeks.', 'interventionNames': ['Procedure: 15-minute Ultrasound Group']}], 'interventions': [{'name': '5-minute Ultrasound Group', 'type': 'PROCEDURE', 'description': 'Pulsed ultrasound therapy applied at 1 W/cm² intensity and 1 MHz frequency for 5 minutes per session, 4 weeks duration.', 'armGroupLabels': ['5-minute Ultrasound Group']}, {'name': '10-minute Ultrasound Group', 'type': 'PROCEDURE', 'description': 'Pulsed ultrasound therapy applied at 1 W/cm² intensity and 1 MHz frequency for 10 minutes per session, 4 weeks duration.', 'armGroupLabels': ['10-minute Ultrasound Group']}, {'name': '15-minute Ultrasound Group', 'type': 'PROCEDURE', 'description': 'Pulsed ultrasound therapy applied at 1 W/cm² intensity and 1 MHz frequency for 15 minutes per session, 4 weeks duration.', 'armGroupLabels': ['15-minute Ultrasound Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42080', 'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'KTO Karatay Üniversitesi', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KTO Karatay University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Mustafa Savaş Torlak', 'investigatorAffiliation': 'KTO Karatay University'}}}}