Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:22 AM
Study NCT ID:
NCT07484594
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrated Trunk Stabilization With Osteoarthritis Rehabilitation in Knee-Spine Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-16', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': '6 weeks', 'description': 'The Visual Analog Scale (VAS) is a simple and reliable tool for assessing pain intensity on a continuous visual scale.'}, {'measure': 'Western Ontario and McMaster Universities Arthritis Index (WOMAC)', 'timeFrame': '6 weeks', 'description': 'It is widely used in the evaluation of knee osteoarthritis to assess activities of daily living, functional mobility, gait, general health, and quality of life.'}], 'secondaryOutcomes': [{'measure': 'Range Of motion (ROM)', 'timeFrame': '6 weeks', 'description': 'A Goniometer is used to measure active and passive ROM for knee flexion and extension while the patient lies supine'}, {'measure': 'Time-Up-and-Go (TUG)', 'timeFrame': '6 weeks', 'description': 'This test is a widely used assessment of functional mobility, particularly in patients with knee osteoarthritis. The test measures the total time it takes for a patient to stand up from a chair, walk 3 meters at a comfortable pace, turn around, walk back to the chair, and sit down'}, {'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': '6 weeks', 'description': 'It is a questionnaire that gives a subjective percentage score of level of function/disability in activities of daily living of patients with low back pain.'}, {'measure': 'Flexicurve (Lumbar Range of motion)', 'timeFrame': '6 weeks', 'description': "Flexicurve is a flexible plastic-coated metal ruler molded to the lumbar spine's sagittal contour (typically T12 to S1) to non-invasively measure lordosis angle via traced perpendicular heights, serving as a radiation-free alternative to X-rays"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee Osteoarthritis, Knee-Spine syndrome, Trunk exercises'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effects of integrating trunk stabilization exercises with conventional rehabilitation in patients with knee-spine syndrome. It further examines whether improving trunk stability can reduce knee pain and enhance functional outcomes in knee osteoarthritis', 'detailedDescription': 'This study aims to evaluate the effects of integrating trunk stabilization exercises with conventional rehabilitation protocols for patients with knee-spine syndrome. It seeks to determine whether improving trunk stability can positively influence knee joint mechanics, leading to a reduction in knee pain and improvements in physical function, mobility, and overall functional performance in individuals with knee osteoarthritis. The findings may support a more comprehensive rehabilitation approach addressing both spinal and knee involvement in osteoarthritis management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40-60 years\n* Both Genders\n* Bilateral Knee osteoarthritis diagnosed according to the American College of Rheumatology Clinical Classification system\n* Kellgren \\& Lawrence grade 2 and 3 with complaint of pain, crepitations, stiffness and bony enlargement\n* History of backpain for the past 3 months with no complaint of radiating pain\n* Able to walk independently/unaided\n\nExclusion Criteria:\n\n* Kellgren \\& Lawrence grade 4\n* Intra-articular corticosteroid injections in the last 3 months or hyaluronic knee injection in the previous 6 months.\n* History of lower limb or lumbar trauma/surgery, presence of fracture or deformity, or planned surgery within the study period\n* Lumbar pathologies, for example, spondylolisthesis, ankylosing spondylitis, or any diagnosed severe cardiovascular, pulmonary, neurological, or psychological disease or impairment except lumbar spondylosis\n* BMI\\>30\n* Presence of infection, cauda equina syndrome, or meningitis'}, 'identificationModule': {'nctId': 'NCT07484594', 'briefTitle': 'Integrated Trunk Stabilization With Osteoarthritis Rehabilitation in Knee-Spine Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Integrating Trunk Stabilization Exercises With Conventional Rehabilitation Protocol for Osteoarthritis in Patients With Knee-Spine Syndrome', 'orgStudyIdInfo': {'id': 'Tooba Rauf'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trunk Stabilization exercises with conventional Rehab', 'description': 'The intervention will include the conventional knee osteoarthritis rehabilitation protocol comprising mobilization, stretching, and strengthening exercises, along with the following trunk stabilization exercises performed for 6 repetition followed by 30 second rest :\n\n1. Prone extension\n2. Back bridge\n3. Unilateral back bridge\n4. Sideways step-up\n5. Bird dog', 'interventionNames': ['Other: Trunk Stabilization exercises with conventional Rehab']}, {'type': 'OTHER', 'label': 'Conventional Rehabilitation', 'description': "The conventional rehabilitation protocol for knee osteoarthritis included Maitland's mobilization performed at a rate of 2-3 oscillations per second for 2 minutes, followed by stretching exercises held for 30 seconds across three sets. Muscle strengthening exercises were also incorporated, consisting of 10 repetitions with a 15-second hold, performed over four sets.", 'interventionNames': ['Other: Conventional Rehabilitation']}], 'interventions': [{'name': 'Trunk Stabilization exercises with conventional Rehab', 'type': 'OTHER', 'description': 'The protocol for will be followed for 6 weeks, where individuals will perform trunk stabilization exercises with conventional rehabilitation for knee osteoarthritis.', 'armGroupLabels': ['Trunk Stabilization exercises with conventional Rehab']}, {'name': 'Conventional Rehabilitation', 'type': 'OTHER', 'description': 'The protocol for will be followed for 6 weeks, where conventional rehabilitation for knee osteoarthritis will be implemented.', 'armGroupLabels': ['Conventional Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rawalpindi', 'country': 'Pakistan', 'contacts': [{'name': 'Suman Sheraz, PhD', 'role': 'CONTACT', 'email': 'suman.sheraz@riphah.edu.pk', 'phone': '03335646361', 'phoneExt': '03335646361'}, {'name': 'Imran Amjad, PhD', 'role': 'CONTACT', 'email': 'imran.amjad@riphah.edu.pk', 'phone': '03324390125'}, {'name': 'Tooba Rauf, MS-OMPT', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Bahria Active', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}], 'centralContacts': [{'name': 'Suman Sheraz, PhD', 'role': 'CONTACT', 'email': 'suman.sheraz@riphah.edu.pk', 'phone': '03335646361', 'phoneExt': '03335646361'}, {'name': 'Imran Amjad, PhD', 'role': 'CONTACT', 'email': 'imran.amjad@riphah.edu.pk', 'phone': '03324390125', 'phoneExt': '03324390125'}], 'overallOfficials': [{'name': 'Suman Sheraz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}