Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT00826293
Status:
COMPLETED
Last Update Posted:
2013-07-11
First Post:
2009-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Clinical Efficacy of Belting Stabilization for Shoulder Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-09', 'studyFirstSubmitDate': '2009-01-20', 'studyFirstSubmitQcDate': '2009-01-21', 'lastUpdatePostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Primary outcome measure is a subjective measure, the Quick Disability of the Arm, Shoulder and Hand (QuickDASH)', 'timeFrame': 'Outcome measures are collected before the initial treatment, at 3 weeks, and at 6 weeks following the initial treatment'}], 'secondaryOutcomes': [{'measure': 'The secondary subjective outcomes include a joint specific measure, the American shoulder and Elbow Surgeons (ASES) score, and the work limitation questionnaire (WLQ-25).', 'timeFrame': 'Outcome measures are collected before the initial treatment, at 3 weeks, and at 6 weeks following the initial treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rotator Cuff Impingement Syndrome']}, 'descriptionModule': {'briefSummary': 'Application of a belt for stabilization while exercising accelerate and optimize recovery in patients diagnosed with shoulder impingement syndrome.', 'detailedDescription': 'Stabilization through belts is commonly used as an adjunct for treatment of musculoskeletal problems. Although this treatment is popular among clinicians, there is a paucity of evidence on its use for shoulder pathology. The objective of this double-blinded longitudinal randomized controlled trial (RCT) is to determine the clinical efficacy of stabilization belting applied to patients receiving rehabilitation treatment for shoulder impingement syndrome. The study population will include patients who have been referred to the physiotherapy department of the Holland Orthopaedic \\& Arthritic Centre for conservative treatment. Patients will be randomized into the treatment and control groups. The primary outcome measure is the Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of impingement syndrome or post-surgical stiffness with an abnormal scapulothoracic rhythm\n\nExclusion Criteria:\n\n* Inability to speak or read English\n* Evidence of major joint trauma causing fracture\n* Infection\n* Underlying metabolic or inflammatory disease\n* Avascular necrosis\n* Frozen shoulder\n* Major medical illness\n* Psychiatric illness that precluded informed consent'}, 'identificationModule': {'nctId': 'NCT00826293', 'briefTitle': 'The Clinical Efficacy of Belting Stabilization for Shoulder Pain', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'The Clinical Efficacy of Belting Stabilization for Shoulder Pain: A Double Blinded Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '224-2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'True Stabilization Group', 'description': 'Patients will be randomized to one of the two treatment groups (true stabilization vs. sham stabilization). Patients will be exercising with a belt that is expected to reduce impingement of the rotator cuff tendons.', 'interventionNames': ['Procedure: Stabilization belt']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Stabilization', 'description': 'Patients receive sham stabilization. The sham procedure imitates the treatment without any true effect.', 'interventionNames': ['Procedure: Stabilization belt']}], 'interventions': [{'name': 'Stabilization belt', 'type': 'PROCEDURE', 'otherNames': ['Belt Stabilization'], 'description': 'Patients receive true stabilization.', 'armGroupLabels': ['True Stabilization Group']}, {'name': 'Stabilization belt', 'type': 'PROCEDURE', 'otherNames': ['Ineffective stabilization'], 'description': 'Patients receive sham stabilization.', 'armGroupLabels': ['Sham Stabilization']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4Y 1H1', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Holland Orthopaedic and Arthritic Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Helen Razmjou, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Helen Razmjou, Physical Therapist', 'investigatorFullName': 'Dr. Helen Razmjou', 'investigatorAffiliation': 'Sunnybrook Health Sciences Centre'}}}}