Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-29 @ 11:14 AM
Study NCT ID:
NCT06913361
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-06
First Post:
2025-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Gongs Mobilization vs Reverse Distraction Technique in Diabetic Patients With Adhesive Capsulitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002062', 'term': 'Bursitis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-02-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-29', 'studyFirstSubmitDate': '2025-03-29', 'studyFirstSubmitQcDate': '2025-03-29', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NUMERIC PAIN RATING SCALE (NPRS)', 'timeFrame': '12 Months', 'description': 'Value of sensitivity/specificity/ validity/reliability: intra-class correlation coefficient 0.58 to 0.93. Measurement: Numerical Interpretation: The Numeric Pain Rating Scale (NPRS) is a simple and widely used tool for assessing pain intensity. Patients rate their pain on a scale from 0 to 10, where 0 indicates ""no pain"" and 10 indicates ""worst pain imaginable."" The interpretation of NPRS scores helps classify pain severity and monitor changes over time.'}, {'measure': 'SHOULDER PAIN AND DISABILITY INDEX', 'timeFrame': '12 Months', 'description': 'The items of the questionnaire are assessed on a 0-10 numeric rating scale in which 0 means no disability and 10 is maximum disability. The sum of the seven items equals the total score of the PDI, which ranges from 0 to 70, with higher scores reflecting higher interference of pain with daily activities'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adhesive Capsulitis']}, 'descriptionModule': {'briefSummary': 'Adhesive capsulitis (AC) represents a renowned musculoskeletal condition which has been clinically classified as frozen shoulder (FS). Adhesive capsulitis occurs 3-5% of the time in the general population, but in diabetics, the frequency can reach 20%. This study is being conducted to determine the effects of gongs mobilization vs reverse distraction technique in diabetic patients with adhesive capsulitis. This study will be a randomized control trial and data will be collected from Haq Orthopedic Hospital. Sample size is 20 calculated by using G power and adding 20 % attrition.', 'detailedDescription': 'Non-Probability convenient sampling will be used. Participants meeting the inclusion and exclusion criteria will be divided into two groups.10 subjects in group A will be treated Gongs mobilization and group B will be treated with Reverse distraction technique. Conventional therapy will be given to both groups as base line treatment. Both groups have 4 sessions per week for 4 weeks. All participants will be evaluated before and after the treatment using Numeric Pain Rating scale (NPRS), Shoulder pain and Disability Index (SPADI) and goniometer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both males and females.\n* Diagnosed case of Unilateral Adhesive Capsulitis.\n* Age group of 40-60 years.\n* Stage 2 and 3 of Adhesive Capsulitis.\n* Diabetes Mellitus Type II.\n* Patients with decreased ROM (less than or equal to 120 degrees), pain, and mild to moderate levels of type II diabetics (below or equal to 200 mg/dL).\n* No history of shoulder surgeries to the affected shoulder.\n\nExclusion Criteria:\n\n* Systemic arthritic conditions of the shoulder (Rheumatoid arthritis, osteoporosis or malignancies in the shoulder region) .\n* Disorders of the Cervical spine .\n* Corticosteroids injections in the affected Shoulder in preceding 6 weeks.\n* Skin lesions or bruises around the Shoulder.\n* Shoulder injuries such as Rotator cuff tear.\n* Fracture in and around the shoulder joint.'}, 'identificationModule': {'nctId': 'NCT06913361', 'briefTitle': 'Effects of Gongs Mobilization vs Reverse Distraction Technique in Diabetic Patients With Adhesive Capsulitis', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'Effects of Gongs Mobilization vs Reverse Distraction Technique in Diabetic Patients With Adhesive Capsulitis', 'orgStudyIdInfo': {'id': 'MSRSW/Batch-Fall23/791'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gongs Mobilization', 'interventionNames': ['Diagnostic Test: Gongs Mobilization']}, {'type': 'EXPERIMENTAL', 'label': 'Reverse Distraction Technique', 'interventionNames': ['Combination Product: Reverse Distraction Technique']}], 'interventions': [{'name': 'Gongs Mobilization', 'type': 'DIAGNOSTIC_TEST', 'description': "The treatment begins with moist heat for 10 minutes, Gong's mobilization with conventional therapy for 8 minutes. The total treatment time was 45 minutes once a day for four days per week for four weeks.", 'armGroupLabels': ['Gongs Mobilization']}, {'name': 'Reverse Distraction Technique', 'type': 'COMBINATION_PRODUCT', 'description': "The treatment begins with moist heat for 10 minutes, Reverse Distraction technique with conventional therapy for 8 minutes. The total treatment time was 45 minutes once a day for four days per week for four weeks. Position of the patient: side-lying. The patient is lying at the plinth's edge on the unaffected side. In front of the patient is the therapist's position.", 'armGroupLabels': ['Reverse Distraction Technique']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Haq Orthopaedic hospital, Sanda road', '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'}}}}