Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2026-01-09 @ 10:23 AM
Study NCT ID:
NCT06530602
Status:
RECRUITING
Last Update Posted:
2024-08-15
First Post:
2024-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3-Dimensional Shoulder Complex Pain Alignment (3-D SPA) Mobilization on Frozen Shoulder.
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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-01-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2024-07-28', 'studyFirstSubmitQcDate': '2024-07-28', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shoulder Pain and Disability Index', 'timeFrame': '3rd week', 'description': 'Questionnaire comprise of 13 items evaluates both the degree of pain and the level of challenge in performing activities of daily living (ADLs) that involve the use of the upper extremities. The pain subscale comprises 5 items, while the Disability subscale consists of 8 items.'}, {'measure': 'Measure Shoulder Range of Motion in Flexion', 'timeFrame': '3rd week', 'description': 'changes from baseline ROM of shoulder flexion taken with goniometer'}, {'measure': 'Measure Shoulder Range of Motion in Extension', 'timeFrame': '3rd week', 'description': 'changes from baseline ROM of shoulder extension taken with goniometer'}, {'measure': 'Measure Shoulder Range of Motion in abduction', 'timeFrame': '3rd week', 'description': 'changes from baseline ROM of shoulder abduction taken with goniometer'}, {'measure': 'Measure Shoulder Range of Motion in Horizontal abduction', 'timeFrame': '3rd week', 'description': 'changes from baseline ROM of shoulder horizontal abduction taken with goniometer'}, {'measure': 'Measure Shoulder Range of Motion in adduction', 'timeFrame': '3rd week', 'description': 'changes from baseline ROM of shoulder adduction taken with goniometer'}, {'measure': 'Measure Shoulder Range of Motion in horizontal adduction', 'timeFrame': '3rd week', 'description': 'changes from baseline ROM of shoulder horizontal adduction taken with goniometer'}, {'measure': 'Measure Shoulder Range of Motion in Internal rotation', 'timeFrame': '3rd week', 'description': 'changes from baseline ROM of shoulder Internal rotation taken with goniometer'}, {'measure': 'Measure Shoulder Range of Motion in External rotation', 'timeFrame': '3rd week', 'description': 'changes from baseline ROM of shoulder External rotation taken with goniometer'}, {'measure': 'Visual Analysis Scale', 'timeFrame': '3rd week', 'description': 'Maximum score 10 minimum score 0 , it is used for both acute and chronic pain.'}], 'secondaryOutcomes': [{'measure': 'WHOQoL-BREF', 'timeFrame': '3rd week', 'description': 'Measures perception of life quality in four dimensions including physical, psychological, social relationship \\& environmental.'}, {'measure': "Apley's Scratch Test", 'timeFrame': '3rd week', 'description': 'to check movements in all functional planes for the shoulder.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Frozen shoulder', 'QOL', 'Clinical trail', '3 D SPA', 'SPADI'], 'conditions': ['Frozen Shoulder']}, 'descriptionModule': {'briefSummary': 'Ongoing research aims to assess the enhancement of shoulder mobility by specifically addressing restrictions in all three planes of movement. current studies seek to investigate the impact of three-dimensional mobilization technique on their recovery and to prevent progression of disease to reduce pain, alleviate muscle tightness, facilitate tissue healing, and ultimately improve the range of motion in patients. A randomized control trial that will include total 36 participants. The first group will receive 3 Dimensional shoulder pain alignment (3-D SPA) mobilization along with conventional therapy and 2nd group will receive Shoulder mobilization along with conventional therapy. Data collected will be analyzed through SPSS 27.', 'detailedDescription': "Decrease capacity of non contractile tissue ( such as joint capsule ) inflammation of capsule and ligament adhesion affects the shoulder joint, triggering stiffness and pain in Frozen shoulder. About 2% to 5% of the general population reported frozen shoulder without well known cause defined ,out of which Female patients 35 - 65 years of age.\n\nhindrance in quality of life reported with performance of basic activities of daily living due to pain that worsen with movement and specifically at night , stiffness that cause mobility deficit.70% of female population are prone to get frozen shoulder. When reaching overhead, the arm is lifted by movements in the sternoclavicular , acromioclavicular (AC), scapulothoracic (ST), and gleno-humeral joints while overhead activities got limited in frozen shoulder.\n\nAbnormal glenohumeral rhythm at scapulothoracic joint by posterior tilting of scapula and early upward motion of scapula occur. hence a capsular pattern developed in patient that comprise of External rotation, Abduction and Internal rotation.\n\nPhysiotherapy encompassed variety of treatment protocols for frozen shoulder including therapeutic modalities and manual therapy technique's consisting moblization, muscle energy techniques ,spencer's technique ,PNF and some of invasive treatments dry needling and therapeutic exercises.\n\n3 D SPA is latest technique with no literature available for this to be applied to check its effectiveness on frozen shoulder rather it merely applied for post stroke shoulder pain prior in clinical setting . In group A 3-D SPA Moblization is employed that target moblization of AC joint (mobilizing it upward posteriorly) synchronously Scapula mobilized (abduction-adduction, anterior-posterior tilting) with glenohumeral Active motion in (flexion, horizontal abduction, horizontal adduction \\& External Internal rotation) all at once in all 3 planes frontal, sagittal, transverse plane while kaltenborn mobilization in anterior, posterior and inferior direction that is employed in group B, that has been a treatment of choice over the time is effective to treat frozen shoulder.\n\nthe study aim to evaluate the effect of 3-Dimensional Shoulder complex Pain Alignment (3-D SPA) mobilization technique on pain, disability, Range of Motion and quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Local shoulder pain, often present either above the antero-medial and Lateral aspect of the shoulder.\n* Stage II\\& III unilateral frozen shoulder Symptoms.\n* Marked loss Of AROM \\& PROM with at least 50%loss of external rotation.\n* Positive Apley's Scratch test.\n\nExclusion Criteria:\n\n* Radiculopathy.\n* Thoracic-outlet syndrome.\n* Fractures and tumors of the upper extremity.\n* Neurological disorders causing muscle weakness in the shoulder.\n* Corticosteroid injection for frozen shoulder in last 3 months."}, 'identificationModule': {'nctId': 'NCT06530602', 'briefTitle': '3-Dimensional Shoulder Complex Pain Alignment (3-D SPA) Mobilization on Frozen Shoulder.', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effect of 3-Dimensional Shoulder Complex Pain Alignment (3-D SPA) Mobilization on Frozen Shoulder.', 'orgStudyIdInfo': {'id': 'Muniba'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': '3-D SPA (shoulder complex pain alignment) Moblization. Conventional therapy \\& Home Plan Treatment session: 3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions.\n\nModality: Ultrasound Mode: continuous 3 MHz, 1.5 w/cm2 for 6 min', 'interventionNames': ['Other: 3 D SPA (shoulder complex pain alignment) Moblization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Shoulder mobilization (kaltenborn) Conventional therapy \\& Home Plan Treatment session: 3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions.\n\nModality: Ultrasound Mode: continuous 3 MHz, 1.5 w/cm2 for 6 min', 'interventionNames': ['Other: Shoulder Moblization (KaltenBorn)']}], 'interventions': [{'name': '3 D SPA (shoulder complex pain alignment) Moblization', 'type': 'OTHER', 'description': '3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions.', 'armGroupLabels': ['Group A']}, {'name': 'Shoulder Moblization (KaltenBorn)', 'type': 'OTHER', 'description': '3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions.', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Madiha Ali, MSOMPT', 'role': 'CONTACT', 'email': 'madiha.ali@riphah.edu.pk', 'phone': '0331-3360064'}, {'name': 'Muniba Shah, MSOMPT*', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Railway General Hospital', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}], 'centralContacts': [{'name': 'Madiha Ali, MSOMPT', 'role': 'CONTACT', 'email': 'madiha.ali@riphah.edu.pk', 'phone': '0331-3360064'}], 'overallOfficials': [{'name': 'Madiha Ali, MSOMPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}