Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-29 @ 5:07 PM
Study NCT ID:
NCT05577403
Status:
COMPLETED
Last Update Posted:
2025-09-18
First Post:
2021-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Mulligans Mobilization With Movement in Osteoarthritis Knee.
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Allocation: Randomized'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-14', 'studyFirstSubmitDate': '2021-12-07', 'studyFirstSubmitQcDate': '2022-10-10', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain intensity', 'timeFrame': '6 weeks', 'description': 'Visual Analogue scale on 0 to10 cm'}, {'measure': 'Range of Motion', 'timeFrame': '6 weeks', 'description': 'Standard goniometer.'}, {'measure': 'Western Ontario and McMaster universities osteoarthritis (WOMAC) index', 'timeFrame': '6 weeks', 'description': 'Western Ontario and McMaster universities osteoarthritis scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Isometric exercise', 'Osteoarthritis', 'Rehabilitation'], 'conditions': ['Osteo Arthritis Knee']}, 'descriptionModule': {'briefSummary': "To evaluate the effect of Mulligan's mobilization with movement in osteoarthritis of the knee.", 'detailedDescription': "Patients with knee OA diagnosed at the orthopaedic clinic of Tumair general hospital and referred to the physiotherapy department who attended the rehabilitation centre of Majmaah university will be recruited.\n\nPatients will be excluded if they have had a knee or hip injury, sensory deficits in the lower extremity, a history of lower-extremity surgery, a history of a quadriceps or hamstring muscle injury, low back-related leg pain, or any contraindication to manual therapy.\n\nThe protocol was submitted to and approved by the Rehabilitation Research Chair, King Saud University Research Ethics Committee (RRC-2021-17)\n\nParticipants will be requested to sign a written informed consent form approved by the institutional ethics committee. A total of 60 participants were randomly assigned to group A (experimental group): Mulligan's mobilization with movement MWM added isometric strength training, and group B (control group): Sham MWM added isometric strength training. Pre and post-test readings were taken at baseline, week 2, and week 4, respectively. The outcome measures for this study will be maximal voluntary isometric contraction of quadriceps strength (measured by ISOMOVE dynamometer), ROM, and Western Ontario and McMaster universities osteoarthritis (WOMAC) index."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with knee OA with radiological evidence of grade 2 or 3 of the Kellgren and Lawrence scale.\n* Age between 40-65 years, unilateral or bilateral involvement (in the case of bilateral involvement, the more symptomatic knee was included), and pain in and around the knee.\n\nExclusion Criteria:\n\n* Patient will be excluded, if they had any deformity of the knee, hip, or back, had any central or peripheral nervous system involvement.\n* They had received steroids or intra-articular injection within the previous three months, uncooperative patients.'}, 'identificationModule': {'nctId': 'NCT05577403', 'briefTitle': 'Effect of Mulligans Mobilization With Movement in Osteoarthritis Knee.', 'organization': {'class': 'OTHER', 'fullName': 'Majmaah University'}, 'officialTitle': "Effect of Mulligan's Mobilization With Movement Added With Isometric Exercises on Muscle Strength Pain and Disability Associated With Knee Osteoarthritis: A Randomized Controlled Study", 'orgStudyIdInfo': {'id': 'RRC-2021-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': "Mulligan's mobilization with movement added isometric strength training will be given 3 days a week for six weeks.", 'interventionNames': ["Behavioral: Mulligan's mobilization with movement MWM added isometric strength training"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Mobilization-added isometric strength training will be given 3 days a week for six weeks.', 'interventionNames': ["Behavioral: Mulligan's mobilization with movement MWM added isometric strength training"]}], 'interventions': [{'name': "Mulligan's mobilization with movement MWM added isometric strength training", 'type': 'BEHAVIORAL', 'otherNames': ['Sham MWM added isometric strength training'], 'description': "Mulligan's mobilization with movement added isometric exercise:\n\nthe participants in the experimental group will receive a Mulligan's mobilization with movement added isometric exercise.\n\nTreatment will be given for the period of three weeks, for five days a week in both groups.\n\nData will be collected before intervention and after 2nd \\& 4th week of intervention.", 'armGroupLabels': ['Control Group', 'Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15341', 'city': "Al Majma'ah", 'state': 'Riyadh Region', 'country': 'Saudi Arabia', 'facility': 'Rehabilitation center, Majmaah University', 'geoPoint': {'lat': 25.91097, 'lon': 45.35665}}], 'overallOfficials': [{'name': 'Shahnaz Hasan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Majmah University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be kept secure with the principal investigator (Dr. Shahnaz Hasan) and sub-investigator (Dr. Naiyer Shahzad) due to confidentiality issues.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Majmaah University', 'class': 'OTHER'}, 'collaborators': [{'name': 'King Saud University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Shahnaz Hasan, PhD', 'investigatorAffiliation': 'Majmaah University'}}}}