Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-03-27 @ 12:14 PM
Study NCT ID:
NCT02870257
Status:
COMPLETED
Last Update Posted:
2017-10-11
First Post:
2016-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Overload Progressive in the Treatment of Shoulder
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-09', 'studyFirstSubmitDate': '2016-08-04', 'studyFirstSubmitQcDate': '2016-08-16', 'lastUpdatePostDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Numeric pain rating scale (0-10)', 'timeFrame': 'baseline, 10 weeks, 3 months and 6 months'}, {'measure': 'Change in SPADI (Shoulder Pain and Disability Index) Questionnaire (0-100)', 'timeFrame': 'baseline, 10 weeks, 3 months and 6 months'}, {'measure': 'Change in ASES (American Shoulder and Elbow Surgeons) Questionnaire (0-100)', 'timeFrame': 'baseline, 10 weeks, 3 months and 6 months'}], 'secondaryOutcomes': [{'measure': 'Disabilities', 'timeFrame': 'Change from baseline at 10 weeks', 'description': 'DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire (0-100)'}, {'measure': 'Quality of life', 'timeFrame': 'Change from baseline at 10 weeks', 'description': 'WORC (The Western Ontario Rotator Cuff Index) Questionnaire (0-100)'}, {'measure': 'Muscle Strength', 'timeFrame': 'Change from baseline at 10 weeks', 'description': 'Shoulder internal rotation, external rotation, adduction and abduction muscles measured by handheld dynamometer'}, {'measure': 'Scapular kinematic', 'timeFrame': 'Change from baseline at 10 weeks', 'description': '3D data of scapula at 30, 60, 90 and 120° of shoulder abduction'}, {'measure': 'Global impression of recovery', 'timeFrame': 'Change from baseline at 10 weeks, 3 months and 6 months', 'description': 'GPE (global perceived effect) scale (-5 to +5)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Shoulder Impingement Syndrome']}, 'descriptionModule': {'briefSummary': 'Seventy subjects with shoulder impingement syndrome associated with scapular dyskinesis will be recruited and randomized into two groups of treatment. The group "a" will receive a strenghtening protocol with progressive overload during 20 sessions and group "b" will receive the same protocol with minimal load, without change during the 20 sessions. The primary outcomes measures will be pain, function, quality of life, global impression of recovery. The change will be measure from baseline at 10 weeks (after 20 sessions), 3 and 6 months (follow-up). The secundary outcomes will be disability, quality of life measure by other instruments, shoulder muscle strength and scapular 3d kinematic variables. For these data, change will be measure from baseline at 10 weeks (after 20 sessions).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People with diagnosis shoulder impingement syndrome or supraspinatus/rotator cuff tendinopathy or subacromial bursitis\n* shoulder pain for more than 4 months, at least 4 points of pain in 0-10 NPRS\n* at least 130° shoulder active elevation\n* 3 or more positive of 5 physical examination tests (painful arc, external rotation resistence, Neer, empty can (Jobe) and Hawkins-Kennedy\n* positive dynamic scapular dyskinesis in clinical observation\n\nExclusion Criteria:\n\n* Referred pain from vertebral spine\n* previous shoulder, elbow or neck surgery\n* complete rotator cuff tear (positive drop arm sign or substantial shoulder elevation or rotation weakness)\n* neoplastic or neurological disorders\n* previous fracture or dislocation injury (shoulder, humerus, clavicle)\n* adhesive capsulitis signs\n* inflammatory diseases\n* specific treatment for the shoulder in the previous four months (injection, physiotherapy)\n* using drugs in the previous week\n* inability to understand portuguese language'}, 'identificationModule': {'nctId': 'NCT02870257', 'briefTitle': 'Effects of Overload Progressive in the Treatment of Shoulder', 'organization': {'class': 'OTHER', 'fullName': 'University of Nove de Julho'}, 'officialTitle': 'Effects of Overload Progressive in the Treatment of Shoulder Impingement Syndrome Associated With Scapular Dyskinesis: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '1.487.198'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Progressive overload strengthening group', 'description': 'Strengthening protocol with progressive load\n\nStrengthening muscle exercises for the shoulder and scapular with progressive increase of load during 10 weeks (20 sessions)', 'interventionNames': ['Other: Strengthening protocol with progressive load']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Strengthening group', 'description': 'Strengthening protocol without progressive load\n\nStrengthening muscle exercises for the shoulder and scapular without increase of load (minimal load) during 10 weeks (20 sessions)', 'interventionNames': ['Other: Strengthening protocol without progressive load']}], 'interventions': [{'name': 'Strengthening protocol with progressive load', 'type': 'OTHER', 'description': 'Strengthening protocol for scapular and shoulder muscles', 'armGroupLabels': ['Progressive overload strengthening group']}, {'name': 'Strengthening protocol without progressive load', 'type': 'OTHER', 'description': 'Strengthening protocol for scapular and shoulder muscles', 'armGroupLabels': ['Strengthening group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01504001', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'UNINOVE', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'André S Bley, Msd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nove de Julho'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nove de Julho', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'André Serra Bley', 'investigatorAffiliation': 'University of Nove de Julho'}}}}