Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-01 @ 1:55 PM
Study NCT ID:
NCT05903768
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2023-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Capsular Stretching and Passive Joint Mobilization in Idiopathic Adhesive Capsulitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002062', 'term': 'Bursitis'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2023-06-06', 'studyFirstSubmitQcDate': '2023-06-13', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Pain rating scale', 'timeFrame': '4th week', 'description': 'The Numeric Pain rating scale is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.'}, {'measure': 'Range of motion (shoulder flexion)', 'timeFrame': '4th week', 'description': 'changes in shoulder flexion Range of motion from baseline to final session was measured'}, {'measure': 'Range of motion (shoulder extension)', 'timeFrame': '4th week', 'description': 'changes in shoulder extension Range of motion from baseline to final session was measured'}, {'measure': 'Range of motion (shoulder abduction)', 'timeFrame': '4th week', 'description': 'changes in shoulder abduction Range of motion from baseline to final session was measured'}, {'measure': 'Range of motion (shoulder external rotation)', 'timeFrame': '4th week', 'description': 'changes in shoulder external rotation Range of motion from baseline to final session was measured'}, {'measure': 'Range of motion (internal rotation)', 'timeFrame': '4th week', 'description': 'changes in shoulder internal rotation Range of motion from baseline to final session was measured'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Range of motion', 'Shoulder', 'Pain'], 'conditions': ['Adhesive Capsulitis']}, 'referencesModule': {'references': [{'pmid': '34425597', 'type': 'BACKGROUND', 'citation': 'Eckert AJ, Plaumann M, Pehlke S, Beck C, Muhldorfer S, Weickert U, Laimer M, Pfeifer M, Stechemesser L, Holl R. Idiopathic Frozen Shoulder in Individuals with Diabetes: Association with Metabolic Control, Obesity, Antidiabetic Treatment and Demographic Characteristics in Adults with Type 1 or 2 Diabetes from the DPV Registry. Exp Clin Endocrinol Diabetes. 2022 Jul;130(7):468-474. doi: 10.1055/a-1543-8559. Epub 2021 Aug 23.'}, {'pmid': '18061115', 'type': 'BACKGROUND', 'citation': 'Thomas SJ, McDougall C, Brown ID, Jaberoo MC, Stearns A, Ashraf R, Fisher M, Kelly IG. Prevalence of symptoms and signs of shoulder problems in people with diabetes mellitus. J Shoulder Elbow Surg. 2007 Nov-Dec;16(6):748-51. doi: 10.1016/j.jse.2007.02.133.'}, {'pmid': '15358849', 'type': 'BACKGROUND', 'citation': 'Mengiardi B, Pfirrmann CW, Gerber C, Hodler J, Zanetti M. Frozen shoulder: MR arthrographic findings. Radiology. 2004 Nov;233(2):486-92. doi: 10.1148/radiol.2332031219. Epub 2004 Sep 9.'}, {'pmid': '35035234', 'type': 'BACKGROUND', 'citation': 'Janela D, Costa F, Molinos M, Moulder RG, Lains J, Francisco GE, Bento V, Cohen SP, Correia FD. Asynchronous and Tailored Digital Rehabilitation of Chronic Shoulder Pain: A Prospective Longitudinal Cohort Study. J Pain Res. 2022 Jan 8;15:53-66. doi: 10.2147/JPR.S343308. eCollection 2022.'}, {'pmid': '24664198', 'type': 'BACKGROUND', 'citation': 'Paul A, Rajkumar JS, Peter S, Lambert L. Effectiveness of sustained stretching of the inferior capsule in the management of a frozen shoulder. Clin Orthop Relat Res. 2014 Jul;472(7):2262-8. doi: 10.1007/s11999-014-3581-2. Epub 2014 Mar 25.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this research is to determine the effects of capsular stretching versus passive joint mobilization on Pain, range of motion and Quality of life in patients with Idiopathic Adhesive capsulitis.', 'detailedDescription': 'In reference study, patients with Adhesive capsulitis were given the option to examine the immediate effects of posterior capsule stretching and scapular mobilization. They came to the conclusion that extending the posterior capsule improved shoulder range of motion. Current study will assess all shoulder movements and also showing effect on Quality of life of patients with adhesive capsulitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBoth genders\n\n* Age : 30-50 years\n* Pain and Restricted movements of shoulder.\n* Patient With Adhesive Capsulitis of Stage 2\n\nExclusion Criteria:\n\n* Patient with any Intrinsic Etiology such as Haemarthrosis, rheumatoid arthritis ,infection or gout\n* Patient with any severe trauma, Shoulder dislocation, subluxation or ligament injury of the shoulder\n* Fractures of the shoulder\n* Peripheral neurological involvement in the upper extremity.'}, 'identificationModule': {'nctId': 'NCT05903768', 'briefTitle': 'Comparison of Capsular Stretching and Passive Joint Mobilization in Idiopathic Adhesive Capsulitis', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Comparison of Capsular Stretching and Passive Joint Mobilization in Idiopathic Adhesive Capsulitis', 'orgStudyIdInfo': {'id': 'Riphah IU Maria Safdar'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cyriax capsular stretching', 'description': 'Patient will be subjected to Hot Pack prior to treatment. Detailed intervention will include Active range of motion exercises,Home plan exercises.Anterior, Posterior and inferior capsular stretching.', 'interventionNames': ['Other: Cyriax capsular stretching']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mobilization', 'description': "Patient will be subjected to Hot Pack prior to treatment. Detailed intervention will include Active range of motion exercises,Home plan exercises and Maitland's Mobilization:", 'interventionNames': ['Other: Mobilization']}], 'interventions': [{'name': 'Mobilization', 'type': 'OTHER', 'description': "Hot Pack for 5mins,Active range of motion exercises (10 reps x 3 sets),Home plan include: wand exercises, wall-walking exercises, pendulum exercises,towel stretch exercises, Cross Body Adduction (10reps x 2 sets, each)Cold pack for 5 mins.\n\nMaitland's Mobilization: Inferior glide (10x3), posterior glide, (10 reps x 3 sets), anterior glide (10 reps x 3 sets)", 'armGroupLabels': ['Mobilization']}, {'name': 'Cyriax capsular stretching', 'type': 'OTHER', 'description': 'Hot Pack for 5mins,Active range of motion exercises (10 reps x 3 sets),Home plan include: wand exercises, wall-walking exercises, pendulum exercises,towel stretch exercises, Cross Body Adduction (10reps x 2 sets, each)Cold pack for 5 mins.\n\nAnterior, Posterior and inferior capsular stretching would be performed. Each stretch should be held15-30 seconds and repeated 2 to 4 times.', 'armGroupLabels': ['Cyriax capsular stretching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Peshawar', 'state': 'Khyber Pakhtunkhwa', 'country': 'Pakistan', 'facility': 'Lady reading hospital', 'geoPoint': {'lat': 34.008, 'lon': 71.57849}}], 'overallOfficials': [{'name': 'Ramsha Tariq, MS-OMPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}