Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-28 @ 3:18 PM
Study NCT ID:
NCT06664632
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-29
First Post:
2024-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Knee Sync Partner and Strengthening Exercises Versus Strengthening Exercises in Knee Osteoarthritis.RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-28', 'studyFirstSubmitDate': '2024-10-28', 'studyFirstSubmitQcDate': '2024-10-28', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WOMAC Scale', 'timeFrame': '12 Months', 'description': 'The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This study explores the effectiveness of a novel treatment approach for knee osteoarthritis (OA) by comparing the combined use of a new device, "Knee Sync Partner," which provides electrical knee traction with stimulation and strengthening exercises, to traditional strengthening exercises alone. Knee osteoarthritis is a leading cause of chronic pain and disability worldwide, significantly impacting the quality of life for many individuals, especially with the growing elderly population.', 'detailedDescription': 'While strengthening exercises are a well-established treatment for improving joint stability and mobility in knee OA patients, the potential benefits of integrating electrical stimulation and traction therapy remain underexplored. This research addresses the gap by conducting a randomized controlled trial to assess whether this combined approach leads to superior outcomes in terms of pain relief, functional improvement, and joint health. The findings could provide valuable insights into more effective, non-invasive management strategies for knee OA, expanding therapeutic options in physical therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* having pain in knee for more than 3 months in most days of week\n* age between 40 and 70 years\n* patient who filled Kellgren-Lawrence radiographic criteria\n\nExclusion Criteria:\n\n* joint injection in the previous three months.\n* The exclusion criteria were patients who had inflammatory arthritis\n* osteoarthritis of the hips.'}, 'identificationModule': {'nctId': 'NCT06664632', 'briefTitle': 'Effectiveness of Knee Sync Partner and Strengthening Exercises Versus Strengthening Exercises in Knee Osteoarthritis.RCT', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'Effectiveness of Knee Sync Partner and Strengthening Exercises Versus Strengthening Exercises in Knee Osteoarthritis. A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'MSRSW/Batch-Fall22/745'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exp Group', 'interventionNames': ['Behavioral: Exp']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'interventionNames': ['Diagnostic Test: control']}], 'interventions': [{'name': 'Exp', 'type': 'BEHAVIORAL', 'description': 'Participants in this group will receive treatment using the Knee Sync Partner, a novel portable device designed to provide electrical traction and stimulation specifically for the knee joint.\n\ncontrolled mechanical traction to the knee joint to reduce joint contact pressure, enhance synovial fluid flow, and increase joint space. This is expected to alleviate pain and improve mobility.', 'armGroupLabels': ['Exp Group']}, {'name': 'control', 'type': 'DIAGNOSTIC_TEST', 'description': 'This will include a combination of isometric and isotonic exercises aimed at strengthening the knee musculature, enhancing joint stability, and reducing pain. The exercise regimen will focus on major muscle groups supporting the knee, such as the quadriceps, hamstrings, and calf muscles.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Superior University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Naveed Babur', 'investigatorAffiliation': 'Superior University'}}}}