Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-30 @ 12:24 PM
Study NCT ID:
NCT06751095
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-27
First Post:
2024-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects Of Maitland's Mobilization At Mid Versus End Range In Knee Osteoarthritis Patients
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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-20', 'studyFirstSubmitDate': '2024-12-20', 'studyFirstSubmitQcDate': '2024-12-20', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Pain Rating Scale', 'timeFrame': '4 Weeks', 'description': 'The Numerical Pain Rating Scale (NPRS) is a commonly used self-report measure to assess the intensity of pain experienced by individuals. Participants rate their pain on a numerical scale, typically ranging from 0 (no pain) to 10 (worst possible pain).'}], 'secondaryOutcomes': [{'measure': 'WOMAC Osteoarthritis INDEX', 'timeFrame': '4 weeks', 'description': 'The western Ontario and McMaster Universities Arthritis Index(WOMAC) is widely uses in the evaluation of Hip and Knee Osteoarthritis. It is a self administrated questionnaire consisting of 24 item divided into 3 sub-scales: Pain(5items) ,stiffness(2 items) and physical function (17 items)'}, {'measure': 'Universal Goniometer', 'timeFrame': '4 weeks', 'description': 'It will measure range of motion of Knee'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['joint range of motion', 'knee osteoarthritis'], 'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '30167975', 'type': 'BACKGROUND', 'citation': 'Suzuki Y, Iijima H, Tashiro Y, Kajiwara Y, Zeidan H, Shimoura K, Nishida Y, Bito T, Nakai K, Tatsumi M, Yoshimi S, Tsuboyama T, Aoyama T. Home exercise therapy to improve muscle strength and joint flexibility effectively treats pre-radiographic knee OA in community-dwelling elderly: a randomized controlled trial. Clin Rheumatol. 2019 Jan;38(1):133-141. doi: 10.1007/s10067-018-4263-3. Epub 2018 Aug 30.'}, {'pmid': '10986299', 'type': 'BACKGROUND', 'citation': 'Steultjens MP, Dekker J, van Baar ME, Oostendorp RA, Bijlsma JW. Range of joint motion and disability in patients with osteoarthritis of the knee or hip. Rheumatology (Oxford). 2000 Sep;39(9):955-61. doi: 10.1093/rheumatology/39.9.955.'}, {'pmid': '36094367', 'type': 'BACKGROUND', 'citation': 'Pozsgai M, Udvaracz K, Peter IA, Than P, Nusser N. Effect of single end-range and not end-range Maitland mobilization on pressure pain threshold and functional measures in knee osteoarthritis: randomised, controlled clinical trial. Eur J Phys Rehabil Med. 2022 Oct;58(5):774-783. doi: 10.23736/S1973-9087.22.07506-2. Epub 2022 Sep 12.'}]}, 'descriptionModule': {'briefSummary': "Knee Osteoarthritis (OA) is the most common form of arthritis affecting mostly elderly people contributing to major cause of disability worldwide.In knee osteoarthritis Maitland's manual therapy technique could be the most effective technique among all in decreasing pain sensitivity and increasing range of motion in knee OA.The aim of this study to compare effects of Maitland's mobilization at mid range versus end range on pain. range of motion and functional disability in patients with knee OA, providing useful insights for healthcare professionals to optimize treatment strategies and enhance outcomes in this context.", 'detailedDescription': "Knee Osteoarthritis (OA) is the most common form of arthritis affecting mostly elderly people contributing to major cause of disability worldwide.In knee osteoarthritis Maitland's manual therapy technique could be the most effective technique among all in decreasing pain sensitivity and increasing range of motion in knee OA.The aim of this study to compare effects of Maitland's mobilization at mid range versus end range on pain. range of motion and functional disability in patients with knee OA, providing useful insights for healthcare professionals to optimize treatment strategies and enhance outcomes in this context.\n\nThis Randomized Clinical Trial will be conducted at DHQ Gujrat through consecutive sampling technique on 44 patients which will be allocated using simple random sampling through sealed opaque enveloped into (Group A and Group B).Maitland's mobilization at end range(Group A) incorporates the end range Maitland's mobilization,strengthening exercises, knee isometrics, transcutaneous electrical stimulation(TENS) and heating pad .\n\nMaitland's mobilization in Mid range (Group B) will be treated with Mid range Maitland's mobilization, TENS,strengthening exercises,knee isometrics and heating pad.Outcomes, encompassing pain levels, range of motion(ROM), and functional disability will be evaluated through Visual analogue scale (VAS),Goniometer and WOMAC scale.The treatment plan spans 4 weeks, comprising 3 sessions per week. Data will be analyzed during SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. Data will be collected at baseline and after 4 weeks of follow up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with age between 40 to 60 years.\n* Participants of both genders will be included.\n* Patient with unilateral/bilateral symptomatic tibiofemoral knee OA.\n* Patient suffering from stiffness less than 30 minutes\n* Patients with radiologically diagnosed case of grade 2 knee OA according to the Kellgren and Lawrence scale\n* Patients with reported peak knee pain of \\>3 on visual analogue scale (VAS)\n\nExclusion Criteria:\n\n* Participants with acute inflammation of knee\n* Participants with severe degenerative lumbar spine disease e.g spondylolisthesis\n* Participants with systemic inflammatory arthritic or neurological conditions\n* Participants with intraarticular injection in the prior 3 months\n* Participants with unstable heart condition\n* Participants with received physical therapy of knee in last 3 months'}, 'identificationModule': {'nctId': 'NCT06751095', 'briefTitle': "Effects Of Maitland's Mobilization At Mid Versus End Range In Knee Osteoarthritis Patients", 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': "Effects Of Maitland's Mobilization At Mid Versus End Range On Pain, Range Of Motion And Functional Disability In Patients With Knee Osteoarthritis.", 'orgStudyIdInfo': {'id': 'REC/RCR&AHS/24/0114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Maitland's Mobilization in End Range", 'description': 'End-range mobilization will be performed individually in flexion and extension end range of the tibiofemoral joint(0-135 degree).', 'interventionNames': ["Other: Maitland's Mobilization in End range"]}, {'type': 'EXPERIMENTAL', 'label': "Maitland's Mobilization in Mid Range", 'description': "Mid range Maitland's mobilization will be performed in (approx. 50-70° knee flexion) of the tibiofemoral joint.", 'interventionNames': ["Other: Maitland's mobilization in Mid range"]}], 'interventions': [{'name': "Maitland's Mobilization in End range", 'type': 'OTHER', 'description': 'End-range mobilization will be performed individually in flexion and extension end range of the tibiofemoral joint .(0-135 degree)', 'armGroupLabels': ["Maitland's Mobilization in End Range"]}, {'name': "Maitland's mobilization in Mid range", 'type': 'OTHER', 'description': "Mid range Maitland's mobilization will be performed in (approx. 50-70° knee flexion) of the tibiofemoral joint", 'armGroupLabels': ["Maitland's Mobilization in Mid Range"]}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Saba Rafique Dr., DPT,MS-OMPT', 'role': 'CONTACT', 'email': 'saba.rafique@riphah.edu.pk', 'phone': '03034045433'}, {'name': 'Saba Rafique Dr., DPT, MS-OMPT', 'role': 'CONTACT', 'email': 'saba.rafique@riphah.edu.pk', 'phone': '03034045433'}], 'overallOfficials': [{'name': 'Zainab Amjad Dr., DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}