Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-03-03 @ 12:41 AM
Study NCT ID:
NCT01333527
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2011-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Early Mobilization Following Arthroscopic Rotator Cuff Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053825', 'term': 'Suburethral Slings'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anelise.silveira@ahs.ca', 'phone': '780-492-2398', 'title': 'Anelise Silveira', 'organization': 'Research Associate'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Over 24 months', 'eventGroups': [{'id': 'EG000', 'title': 'Group A (Early ROM)', 'description': 'Group A (early ROM) will use the sling for comfort only\n\nNo Sling: Early range of motion\n\nOverall number of Baseline participants: 103. \\>18 years, continuous Sex: male and female Region of enrollment', 'otherNumAtRisk': 103, 'deathsNumAtRisk': 103, 'otherNumAffected': 10, 'seriousNumAtRisk': 103, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group B (Usual Care)', 'description': 'Group B (usual care) will be immobilized in a sling for 6 weeks.\n\nSling: Patients will use the sling for 6 weeks, as per usual care\n\nOverall number of Baseline participants 103 \\>18 years, continuous Sex: male and female Region of enrollment', 'otherNumAtRisk': 103, 'deathsNumAtRisk': 103, 'otherNumAffected': 6, 'seriousNumAtRisk': 103, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Persistent Pain', 'notes': 'Pain in the surgical shoulder that needed further intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Western Ontario Rotator Cuff Index (WORC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Early ROM)', 'description': 'Group A (early ROM) will use the sling for comfort only\n\nNo Sling: Early range of motion\n\nOverall number of Baseline participants: 103. \\>18 years, continuous Sex: male and female Region of enrollment'}, {'id': 'OG001', 'title': 'Group B (Usual Care)', 'description': 'Group B (usual care) will be immobilized in a sling for 6 weeks.\n\nSling: Patients will use the sling for 6 weeks, as per usual care\n\nOverall number of Baseline participants 103 \\>18 years, continuous Sex: male and female Region of enrollment'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '39.2', 'spread': '18.4', 'groupId': 'OG000'}, {'value': '40.2', 'spread': '17.3', 'groupId': 'OG001'}]}]}, {'title': '6 weeks', 'categories': [{'measurements': [{'value': '44.5', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '40.7', 'spread': '14.0', 'groupId': 'OG001'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '61.4', 'spread': '19.0', 'groupId': 'OG000'}, {'value': '63.7', 'spread': '17.6', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '78.6', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '79.6', 'spread': '15.2', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '87.6', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '88.6', 'spread': '13.1', 'groupId': 'OG001'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '89.4', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '89.8', 'spread': '13.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months', 'description': 'a 5-part (physical symptoms, sports/recreation, work, lifestyle, emotions) 21-item disease specific questionnaire. Measured in percentage. 0% = worst, 100 % = best', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Range of Motion (ROM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Early ROM)', 'description': 'Group A (early ROM) will use the sling for comfort only\n\nNo Sling: Early range of motion\n\nOverall number of Baseline participants: 103. \\>18 years, continuous Sex: male and female Region of enrollment'}, {'id': 'OG001', 'title': 'Group B (Usual Care)', 'description': 'Group B (usual care) will be immobilized in a sling for 6 weeks.\n\nSling: Patients will use the sling for 6 weeks, as per usual care\n\nOverall number of Baseline participants 103 \\>18 years, continuous Sex: male and female Region of enrollment'}], 'classes': [{'title': 'Forward Flexion baseline', 'categories': [{'measurements': [{'value': '131.5', 'spread': '30.0', 'groupId': 'OG000'}, {'value': '127.4', 'spread': '34.9', 'groupId': 'OG001'}]}]}, {'title': 'Forward Flexion 6 weeks', 'categories': [{'measurements': [{'value': '90.0', 'spread': '33.4', 'groupId': 'OG000'}, {'value': '78.9', 'spread': '34.5', 'groupId': 'OG001'}]}]}, {'title': 'Forward Flexion 3 months', 'categories': [{'measurements': [{'value': '125.5', 'spread': '28.5', 'groupId': 'OG000'}, {'value': '121.0', 'spread': '30.1', 'groupId': 'OG001'}]}]}, {'title': 'Forward Flexion 6 months', 'categories': [{'measurements': [{'value': '142.3', 'spread': '22.6', 'groupId': 'OG000'}, {'value': '141.3', 'spread': '22.6', 'groupId': 'OG001'}]}]}, {'title': 'Forward Flexion12 months', 'categories': [{'measurements': [{'value': '150.9', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '149.0', 'spread': '19.9', 'groupId': 'OG001'}]}]}, {'title': 'Forward Flexion 24 months', 'categories': [{'measurements': [{'value': '155.5', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '152.2', 'spread': '18.5', 'groupId': 'OG001'}]}]}, {'title': 'Abduction baseline', 'categories': [{'measurements': [{'value': '121.1', 'spread': '36.0', 'groupId': 'OG000'}, {'value': '118.6', 'spread': '39.4', 'groupId': 'OG001'}]}]}, {'title': 'Abduction 6 weeks', 'categories': [{'measurements': [{'value': '75.4', 'spread': '36.8', 'groupId': 'OG000'}, {'value': '67.1', 'spread': '32.9', 'groupId': 'OG001'}]}]}, {'title': 'Abduction 3 months', 'categories': [{'measurements': [{'value': '119.1', 'spread': '31.3', 'groupId': 'OG000'}, {'value': '116.0', 'spread': '37.6', 'groupId': 'OG001'}]}]}, {'title': 'Abduction 6 months', 'categories': [{'measurements': [{'value': '139.4', 'spread': '23.5', 'groupId': 'OG000'}, {'value': '139.5', 'spread': '27.6', 'groupId': 'OG001'}]}]}, {'title': 'Abduction 12 months', 'categories': [{'measurements': [{'value': '150.0', 'spread': '15.3', 'groupId': 'OG000'}, {'value': '148.4', 'spread': '22.4', 'groupId': 'OG001'}]}]}, {'title': 'Abduction 24 months', 'categories': [{'measurements': [{'value': '153.5', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '152.2', 'spread': '21.9', 'groupId': 'OG001'}]}]}, {'title': 'External Rotation in Abduction Baseline', 'categories': [{'measurements': [{'value': '62.2', 'spread': '34.1', 'groupId': 'OG000'}, {'value': '61.6', 'spread': '31.6', 'groupId': 'OG001'}]}]}, {'title': 'External Rotation in Abduction 6 weeks', 'categories': [{'measurements': [{'value': '22.0', 'spread': '29.2', 'groupId': 'OG000'}, {'value': '19.5', 'spread': '28.8', 'groupId': 'OG001'}]}]}, {'title': 'External Rotation in Abduction 3 months', 'categories': [{'measurements': [{'value': '53.0', 'spread': '27.6', 'groupId': 'OG000'}, {'value': '44.2', 'spread': '28.8', 'groupId': 'OG001'}]}]}, {'title': 'External Rotation in Abduction 6 months', 'categories': [{'measurements': [{'value': '67.6', 'spread': '21.0', 'groupId': 'OG000'}, {'value': '62.9', 'spread': '21.6', 'groupId': 'OG001'}]}]}, {'title': 'External Rotation in Abduction 12 months', 'categories': [{'measurements': [{'value': '75.3', 'spread': '16.2', 'groupId': 'OG000'}, {'value': '70.6', 'spread': '18.8', 'groupId': 'OG001'}]}]}, {'title': 'External Rotation in Abduction 24 months', 'categories': [{'measurements': [{'value': '76.0', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '71.5', 'spread': '17.8', 'groupId': 'OG001'}]}]}, {'title': 'Internal rotation in abduction baseline', 'categories': [{'measurements': [{'value': '30.6', 'spread': '18.6', 'groupId': 'OG000'}, {'value': '33.2', 'spread': '17.6', 'groupId': 'OG001'}]}]}, {'title': 'Internal rotation in abduction 6 weeks', 'categories': [{'measurements': [{'value': '14.1', 'spread': '18.6', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '16.6', 'groupId': 'OG001'}]}]}, {'title': 'Internal rotation in abduction 3 months', 'categories': [{'measurements': [{'value': '30.2', 'spread': '15.2', 'groupId': 'OG000'}, {'value': '25.9', 'spread': '16.3', 'groupId': 'OG001'}]}]}, {'title': 'Internal rotation in abduction 6 months', 'categories': [{'measurements': [{'value': '35.9', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '35.5', 'spread': '12.2', 'groupId': 'OG001'}]}]}, {'title': 'Internal rotation in abduction 12 months', 'categories': [{'measurements': [{'value': '39.0', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '40.1', 'spread': '14.4', 'groupId': 'OG001'}]}]}, {'title': 'Internal rotation in abduction 24 months', 'categories': [{'measurements': [{'value': '40.9', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '38.7', 'spread': '12.4', 'groupId': 'OG001'}]}]}, {'title': 'Horizontal adduction baseline', 'categories': [{'measurements': [{'value': '13.2', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '14.4', 'spread': '10.3', 'groupId': 'OG001'}]}]}, {'title': 'Horizontal adduction 6 weeks', 'categories': [{'measurements': [{'value': '8.2', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '9.3', 'groupId': 'OG001'}]}]}, {'title': 'Horizontal adduction 3 months', 'categories': [{'measurements': [{'value': '14.9', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '9.7', 'groupId': 'OG001'}]}]}, {'title': 'Horizontal adduction 6 months', 'categories': [{'measurements': [{'value': '19.4', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '18.1', 'spread': '9.9', 'groupId': 'OG001'}]}]}, {'title': 'Horizontal adduction 12 months', 'categories': [{'measurements': [{'value': '19.1', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '18.9', 'spread': '10.4', 'groupId': 'OG001'}]}]}, {'title': 'Horizontal adduction 24 months', 'categories': [{'measurements': [{'value': '20.4', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '19.5', 'spread': '11.5', 'groupId': 'OG001'}]}]}, {'title': 'Scaption baseline', 'categories': [{'measurements': [{'value': '124.6', 'spread': '31.3', 'groupId': 'OG000'}, {'value': '123.6', 'spread': '34.8', 'groupId': 'OG001'}]}]}, {'title': 'Scaption 6 weeks', 'categories': [{'measurements': [{'value': '80.4', 'spread': '33.1', 'groupId': 'OG000'}, {'value': '75.8', 'spread': '36.3', 'groupId': 'OG001'}]}]}, {'title': 'Scaption 3 months', 'categories': [{'measurements': [{'value': '120.7', 'spread': '28.0', 'groupId': 'OG000'}, {'value': '118.5', 'spread': '31.0', 'groupId': 'OG001'}]}]}, {'title': 'Scaption 6 months', 'categories': [{'measurements': [{'value': '138.0', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '137.9', 'spread': '23.6', 'groupId': 'OG001'}]}]}, {'title': 'Scaption 12 months', 'categories': [{'measurements': [{'value': '148.7', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '146.7', 'spread': '20.2', 'groupId': 'OG001'}]}]}, {'title': 'Scaption 24 months', 'categories': [{'measurements': [{'value': '151.7', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '149.7', 'spread': '18.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months', 'description': 'Measured flexion, abduction, external rotation in 90 degrees abduction \\[ER(90)\\], internal rotation in 90 degrees abduction \\[IR(90)\\], horizontal adduction, scaption, degrees with a goniometer by the same tester throughout', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Early ROM)', 'description': 'Group A (early ROM) will use the sling for comfort only\n\nNo Sling: Early range of motion\n\nOverall number of Baseline participants: 103. \\>18 years, continuous Sex: male and female Region of enrollment'}, {'id': 'OG001', 'title': 'Group B (Usual Care)', 'description': 'Group B (usual care) will be immobilized in a sling for 6 weeks.\n\nSling: Patients will use the sling for 6 weeks, as per usual care\n\nOverall number of Baseline participants 103 \\>18 years, continuous Sex: male and female Region of enrollment'}], 'classes': [{'title': 'Flexion baseline', 'categories': [{'measurements': [{'value': '19.6', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '19.8', 'spread': '12.3', 'groupId': 'OG001'}]}]}, {'title': 'Flexion 6 months', 'categories': [{'measurements': [{'value': '26.3', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '27.1', 'spread': '10.8', 'groupId': 'OG001'}]}]}, {'title': 'Flexion 12 months', 'categories': [{'measurements': [{'value': '29.7', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '31.0', 'spread': '12.7', 'groupId': 'OG001'}]}]}, {'title': 'Flexion 24 months', 'categories': [{'measurements': [{'value': '28.3', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '29.1', 'spread': '11.7', 'groupId': 'OG001'}]}]}, {'title': 'Abduction baseline', 'categories': [{'measurements': [{'value': '18.6', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '10.1', 'groupId': 'OG001'}]}]}, {'title': 'Abduction 6 months', 'categories': [{'measurements': [{'value': '23.2', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '23.2', 'spread': '9.3', 'groupId': 'OG001'}]}]}, {'title': 'Abduction 12 months', 'categories': [{'measurements': [{'value': '26.8', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '26.9', 'spread': '10.5', 'groupId': 'OG001'}]}]}, {'title': 'Abduction 24 months', 'categories': [{'measurements': [{'value': '26.9', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '28.2', 'spread': '10.6', 'groupId': 'OG001'}]}]}, {'title': 'External rotation in abduction baseline', 'categories': [{'measurements': [{'value': '11.5', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '9.6', 'groupId': 'OG001'}]}]}, {'title': 'External rotation in abduction 6 months', 'categories': [{'measurements': [{'value': '18.2', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '18.7', 'spread': '10.1', 'groupId': 'OG001'}]}]}, {'title': 'External rotation in abduction 12 months', 'categories': [{'measurements': [{'value': '23.3', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '24.0', 'spread': '12.3', 'groupId': 'OG001'}]}]}, {'title': 'External rotation in abduction 24 months', 'categories': [{'measurements': [{'value': '25.1', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '24.8', 'spread': '11.8', 'groupId': 'OG001'}]}]}, {'title': 'Internal rotation in abduction baseline', 'categories': [{'measurements': [{'value': '18.1', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '19.5', 'spread': '14.1', 'groupId': 'OG001'}]}]}, {'title': 'Internal rotation in abduction 6 months', 'categories': [{'measurements': [{'value': '27.1', 'spread': '14.5', 'groupId': 'OG000'}, {'value': '26.7', 'spread': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'Internal rotation in abduction 12 months', 'categories': [{'measurements': [{'value': '30.9', 'spread': '15.2', 'groupId': 'OG000'}, {'value': '32.3', 'spread': '14.4', 'groupId': 'OG001'}]}]}, {'title': 'Internal rotation in abduction 24 months', 'categories': [{'measurements': [{'value': '30.6', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '31.3', 'spread': '13.4', 'groupId': 'OG001'}]}]}, {'title': 'Horizontal Adduction baseline', 'categories': [{'measurements': [{'value': '17.7', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '20.0', 'spread': '13.4', 'groupId': 'OG001'}]}]}, {'title': 'Horizontal Adduction 6 months', 'categories': [{'measurements': [{'value': '25.7', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '25.4', 'spread': '10.7', 'groupId': 'OG001'}]}]}, {'title': 'Horizontal Adduction 12 months', 'categories': [{'measurements': [{'value': '28.1', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '28.4', 'spread': '11.6', 'groupId': 'OG001'}]}]}, {'title': 'Horizontal Adduction 24 months', 'categories': [{'measurements': [{'value': '27.9', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '28.2', 'spread': '11.1', 'groupId': 'OG001'}]}]}, {'title': 'Scaption baseline', 'categories': [{'measurements': [{'value': '14.2', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '13.9', 'spread': '7.2', 'groupId': 'OG001'}]}]}, {'title': 'Scaption 6 months', 'categories': [{'measurements': [{'value': '16.4', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '16.3', 'spread': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'Scaption 12 months', 'categories': [{'measurements': [{'value': '19.8', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '19.1', 'spread': '7.0', 'groupId': 'OG001'}]}]}, {'title': 'Scaption 24 months', 'categories': [{'measurements': [{'value': '20.6', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '19.7', 'spread': '7.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months, 12 months, 24 months', 'description': 'strength was measured in pounds of force using a dynamometer (microFET3, Hoggan Health Industries, West Jordan, UT). Isometric shoulder flexion, abduction, were measured with the arm in neutral abduction and elbow at 90 degrees flexion. External and internal rotation were measured in 90 degrees of abduction. Peak values were recorded during each contraction which was held for 3 seconds. Values were expressed as raw values.', 'unitOfMeasure': 'pounds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Short Form (36) Health Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Early ROM)', 'description': 'Group A (early ROM) will use the sling for comfort only\n\nNo Sling: Early range of motion\n\nOverall number of Baseline participants: 103. \\>18 years, continuous Sex: male and female Region of enrollment'}, {'id': 'OG001', 'title': 'Group B (Usual Care)', 'description': 'Group B (usual care) will be immobilized in a sling for 6 weeks.\n\nSling: Patients will use the sling for 6 weeks, as per usual care\n\nOverall number of Baseline participants 103 \\>18 years, continuous Sex: male and female Region of enrollment'}], 'classes': [{'title': 'physical functioning baseline', 'categories': [{'measurements': [{'value': '72.8', 'spread': '15.2', 'groupId': 'OG000'}, {'value': '71.3', 'spread': '16.7', 'groupId': 'OG001'}]}]}, {'title': 'physical functioning 6 weeks', 'categories': [{'measurements': [{'value': '68.2', 'spread': '14.2', 'groupId': 'OG000'}, {'value': '64.7', 'spread': '15.2', 'groupId': 'OG001'}]}]}, {'title': 'physical functioning 3 months', 'categories': [{'measurements': [{'value': '75.0', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '73.7', 'spread': '16.3', 'groupId': 'OG001'}]}]}, {'title': 'physical functioning 6 months', 'categories': [{'measurements': [{'value': '84.4', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '82.7', 'spread': '18.1', 'groupId': 'OG001'}]}]}, {'title': 'physical functioning 12 months', 'categories': [{'measurements': [{'value': '89.3', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '86.3', 'spread': '18.2', 'groupId': 'OG001'}]}]}, {'title': 'physical functioning 24 months', 'categories': [{'measurements': [{'value': '86.8', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '85.7', 'spread': '16.9', 'groupId': 'OG001'}]}]}, {'title': 'role physical baseline', 'categories': [{'measurements': [{'value': '33.2', 'spread': '39.1', 'groupId': 'OG000'}, {'value': '36.6', 'spread': '37.7', 'groupId': 'OG001'}]}]}, {'title': 'role physical 6 weeks', 'categories': [{'measurements': [{'value': '14.7', 'spread': '28.8', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '25.4', 'groupId': 'OG001'}]}]}, {'title': 'role physical 3 months', 'categories': [{'measurements': [{'value': '40.9', 'spread': '42.7', 'groupId': 'OG000'}, {'value': '37.5', 'spread': '41.2', 'groupId': 'OG001'}]}]}, {'title': 'role physical 6 months', 'categories': [{'measurements': [{'value': '71.1', 'spread': '37.6', 'groupId': 'OG000'}, {'value': '65.6', 'spread': '40.2', 'groupId': 'OG001'}]}]}, {'title': 'role physical 12 months', 'categories': [{'measurements': [{'value': '86.1', 'spread': '29.6', 'groupId': 'OG000'}, {'value': '79.8', 'spread': '35.8', 'groupId': 'OG001'}]}]}, {'title': 'role physical 24 months', 'categories': [{'measurements': [{'value': '81.8', 'spread': '33.6', 'groupId': 'OG000'}, {'value': '74.4', 'spread': '38.8', 'groupId': 'OG001'}]}]}, {'title': 'bodily pain baseline', 'categories': [{'measurements': [{'value': '43.5', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '46.3', 'spread': '18.6', 'groupId': 'OG001'}]}]}, {'title': 'bodily pain 6 weeks', 'categories': [{'measurements': [{'value': '50.2', 'spread': '22.8', 'groupId': 'OG000'}, {'value': '45.5', 'spread': '24.0', 'groupId': 'OG001'}]}]}, {'title': 'bodily pain 3 months', 'categories': [{'measurements': [{'value': '62.5', 'spread': '22.5', 'groupId': 'OG000'}, {'value': '66.5', 'spread': '20.5', 'groupId': 'OG001'}]}]}, {'title': 'bodily pain 6 months', 'categories': [{'measurements': [{'value': '69.5', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '71.7', 'spread': '19.2', 'groupId': 'OG001'}]}]}, {'title': 'bodily pain 12 months', 'categories': [{'measurements': [{'value': '74.6', 'spread': '20.0', 'groupId': 'OG000'}, {'value': '75.5', 'spread': '20.8', 'groupId': 'OG001'}]}]}, {'title': 'bodily pain 24 months', 'categories': [{'measurements': [{'value': '73.2', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '76.7', 'spread': '22.7', 'groupId': 'OG001'}]}]}, {'title': 'General Health baseline', 'categories': [{'measurements': [{'value': '79.0', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '76.0', 'spread': '17.9', 'groupId': 'OG001'}]}]}, {'title': 'General Health 6 weeks', 'categories': [{'measurements': [{'value': '78.0', 'spread': '17.1', 'groupId': 'OG000'}, {'value': '77.7', 'spread': '17.0', 'groupId': 'OG001'}]}]}, {'title': 'General Health 3 months', 'categories': [{'measurements': [{'value': '77.6', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '79.3', 'spread': '17.0', 'groupId': 'OG001'}]}]}, {'title': 'General Health 6 months', 'categories': [{'measurements': [{'value': '81.1', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '79.7', 'spread': '15.4', 'groupId': 'OG001'}]}]}, {'title': 'General Health 12 months', 'categories': [{'measurements': [{'value': '80.3', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '80.1', 'spread': '15.7', 'groupId': 'OG001'}]}]}, {'title': 'General Health 24 months', 'categories': [{'measurements': [{'value': '78.8', 'spread': '17.3', 'groupId': 'OG000'}, {'value': '77.2', 'spread': '20.0', 'groupId': 'OG001'}]}]}, {'title': 'Vitality baseline', 'categories': [{'measurements': [{'value': '61.0', 'spread': '20.3', 'groupId': 'OG000'}, {'value': '63.2', 'spread': '18.2', 'groupId': 'OG001'}]}]}, {'title': 'Vitality 6 weeks', 'categories': [{'measurements': [{'value': '58.9', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '57.3', 'spread': '19.2', 'groupId': 'OG001'}]}]}, {'title': 'Vitality 3 months', 'categories': [{'measurements': [{'value': '65.9', 'spread': '18.1', 'groupId': 'OG000'}, {'value': '68.0', 'spread': '16.7', 'groupId': 'OG001'}]}]}, {'title': 'Vitality 6 months', 'categories': [{'measurements': [{'value': '70.4', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '72.9', 'spread': '14.0', 'groupId': 'OG001'}]}]}, {'title': 'Vitality 12 months', 'categories': [{'measurements': [{'value': '73.2', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '73.9', 'spread': '14.0', 'groupId': 'OG001'}]}]}, {'title': 'Vitality 24 months', 'categories': [{'measurements': [{'value': '70.7', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '73.9', 'spread': '16.3', 'groupId': 'OG001'}]}]}, {'title': 'Social function baseline', 'categories': [{'measurements': [{'value': '79.0', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '76.5', 'spread': '22.1', 'groupId': 'OG001'}]}]}, {'title': 'Social function 6 weeks', 'categories': [{'measurements': [{'value': '70.0', 'spread': '26.3', 'groupId': 'OG000'}, {'value': '61.7', 'spread': '26.1', 'groupId': 'OG001'}]}]}, {'title': 'Social function 3 months', 'categories': [{'measurements': [{'value': '82.4', 'spread': '20.0', 'groupId': 'OG000'}, {'value': '81.1', 'spread': '20.6', 'groupId': 'OG001'}]}]}, {'title': 'Social function 6 months', 'categories': [{'measurements': [{'value': '90.5', 'spread': '16.5', 'groupId': 'OG000'}, {'value': '90.4', 'spread': '15.4', 'groupId': 'OG001'}]}]}, {'title': 'Social function 12 months', 'categories': [{'measurements': [{'value': '90.4', 'spread': '17.1', 'groupId': 'OG000'}, {'value': '91.1', 'spread': '17.2', 'groupId': 'OG001'}]}]}, {'title': 'Social function 24 months', 'categories': [{'measurements': [{'value': '86.4', 'spread': '21.3', 'groupId': 'OG000'}, {'value': '88.7', 'spread': '18.8', 'groupId': 'OG001'}]}]}, {'title': 'role emotional baseline', 'categories': [{'measurements': [{'value': '80.2', 'spread': '36.2', 'groupId': 'OG000'}, {'value': '81.4', 'spread': '33.9', 'groupId': 'OG001'}]}]}, {'title': 'role emotional 6 weeks', 'categories': [{'measurements': [{'value': '65.9', 'spread': '42.7', 'groupId': 'OG000'}, {'value': '64.2', 'spread': '43.0', 'groupId': 'OG001'}]}]}, {'title': 'role emotional 3 months', 'categories': [{'measurements': [{'value': '78.0', 'spread': '37.6', 'groupId': 'OG000'}, {'value': '74.5', 'spread': '38.4', 'groupId': 'OG001'}]}]}, {'title': 'role emotional 6 months', 'categories': [{'measurements': [{'value': '89.4', 'spread': '26.7', 'groupId': 'OG000'}, {'value': '82.8', 'spread': '34.5', 'groupId': 'OG001'}]}]}, {'title': 'role emotional 12 months', 'categories': [{'measurements': [{'value': '90.7', 'spread': '25.8', 'groupId': 'OG000'}, {'value': '89.3', 'spread': '25.3', 'groupId': 'OG001'}]}]}, {'title': 'role emotional 24 months', 'categories': [{'measurements': [{'value': '92.2', 'spread': '20.9', 'groupId': 'OG000'}, {'value': '88.2', 'spread': '27.5', 'groupId': 'OG001'}]}]}, {'title': 'Mental health baseline', 'categories': [{'measurements': [{'value': '79.0', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '78.5', 'spread': '13.4', 'groupId': 'OG001'}]}]}, {'title': 'Mental health 6 weeks', 'categories': [{'measurements': [{'value': '79.5', 'spread': '15.6', 'groupId': 'OG000'}, {'value': '76.3', 'spread': '15.4', 'groupId': 'OG001'}]}]}, {'title': 'Mental health 3 months', 'categories': [{'measurements': [{'value': '79.8', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '82.4', 'spread': '12.8', 'groupId': 'OG001'}]}]}, {'title': 'Mental health 6 months', 'categories': [{'measurements': [{'value': '81.9', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '83.9', 'spread': '12.4', 'groupId': 'OG001'}]}]}, {'title': 'Mental health 12 months', 'categories': [{'measurements': [{'value': '82.8', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '83.1', 'spread': '12.2', 'groupId': 'OG001'}]}]}, {'title': 'Mental health 24 months', 'categories': [{'measurements': [{'value': '81.4', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '84.1', 'spread': '12.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months', 'description': 'The Short Form (36) Health Survey is a quality of life questionnaire that looks at eight scales: physical functioning, Role-physical, bodily pain, general health, vitality, social function, role-emotional, mental health. Each scale ranges between 0 (completely disable) to 100 (completely able).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Early ROM)', 'description': 'Group A (early ROM) will use the sling for comfort only\n\nNo Sling: Early range of motion\n\nOverall number of Baseline participants: 103. \\>18 years, continuous Sex: male and female Region of enrollment'}, {'id': 'OG001', 'title': 'Group B (Usual Care)', 'description': 'Group B (usual care) will be immobilized in a sling for 6 weeks.\n\nSling: Patients will use the sling for 6 weeks, as per usual care\n\nOverall number of Baseline participants 103 \\>18 years, continuous Sex: male and female Region of enrollment'}], 'classes': [{'title': 'Superficial Infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Frozen Shoulder', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Biceps Rupture', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Persistent Pain', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Re-injury not requiring surgery', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Urinary', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pulmonary', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Metabolic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nerve Injury', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Deep infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dislocation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hematoma', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dermatitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Reflex Sympathetic Dystrophy (RSD)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Traumatic Re-injury', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks, 6 weeks, 3 months, 6months', 'description': 'The following complications were monitored throughout study:\n\n* Medical related: urinary, gastrointestinal, cardiac, pulmonary, metabolic\n* Surgical related: nerve injury, superficial or deep infection, dislocation, frozen shoulder, hematoma, biceps rupture, failure of tendon healing, dermatitis, reflex sympathetic dystrophy (RSD), persistent pain, re-injury.\n* Other\n\nThe surgeon responsible for the patient used clinical judgment to make a decision regarding if the complication was related or not to the treatment being tested (use or not of sling).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Expected, surgical procedure related: superficial infection, frozen shoulder, biceps rupture, persistent pain, reinjury Unexpected, not treatment related: Traumatic reinjury'}, {'type': 'SECONDARY', 'title': 'Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Early ROM)', 'description': 'Group A (early ROM) will use the sling for comfort only\n\nNo Sling: Early range of motion\n\nOverall number of Baseline participants: 103. \\>18 years, continuous Sex: male and female Region of enrollment'}, {'id': 'OG001', 'title': 'Group B (Usual Care)', 'description': 'Group B (usual care) will be immobilized in a sling for 6 weeks.\n\nSling: Patients will use the sling for 6 weeks, as per usual care\n\nOverall number of Baseline participants 103 \\>18 years, continuous Sex: male and female Region of enrollment'}], 'classes': [{'title': 'Pain at rest - baseline', 'categories': [{'measurements': [{'value': '3.1', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Pain at rest 6 weeks', 'categories': [{'measurements': [{'value': '2.2', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Pain at rest 3 months', 'categories': [{'measurements': [{'value': '1.8', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Pain at rest 6 months', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Pain at rest 12 months', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Pain at rest 24 months', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Pain with activity - baseline', 'categories': [{'measurements': [{'value': '6.1', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Pain with activity 6 weeks', 'categories': [{'measurements': [{'value': '4.4', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Pain with activity 3 months', 'categories': [{'measurements': [{'value': '3.4', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Pain with activity 6 months', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Pain with activity 12 months', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Pain with activity 24 months', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Pain at night - baseline', 'categories': [{'measurements': [{'value': '4.8', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Pain at night 6 weeks', 'categories': [{'measurements': [{'value': '3.3', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Pain at night 3 months', 'categories': [{'measurements': [{'value': '2.3', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Pain at night 6 months', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Pain at night 12 months', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Pain at night 24 months', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 weeks, 3, 6, 12, 24 months', 'description': 'Shoulder pain at rest, with activity and at night were measured using a visual analogue scale of 0-10 (no pain to severe pain)', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A (Early ROM)', 'description': 'Group A (early ROM) will use the sling for comfort only\n\nNo Sling: Early range of motion'}, {'id': 'FG001', 'title': 'Group B (Usual Care)', 'description': 'Group B (usual care) will be immobilized in a sling for 6 weeks.\n\nSling: Patients will use the sling for 6 weeks, as per usual care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '106'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}]}]}], 'preAssignmentDetails': 'Withdrew following randomization (n=5)\n\nReasons:\n\nn=4 : Had Abduction pillow n=1: Excluded at surgery'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A (Early ROM)', 'description': 'Group A (early ROM) used the sling for comfort only'}, {'id': 'BG001', 'title': 'Group B (Usual Care)', 'description': 'Group B (usual care) used the sling for 6 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.5', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '56.2', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '55.85', 'spread': '9.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Range of Motion', 'classes': [{'title': 'Flexion_Baseline', 'categories': [{'measurements': [{'value': '132.1', 'spread': '30.7', 'groupId': 'BG000'}, {'value': '127.7', 'spread': '35.6', 'groupId': 'BG001'}, {'value': '129.91', 'spread': '33.21', 'groupId': 'BG002'}]}]}, {'title': 'Abduction_Baseline', 'categories': [{'measurements': [{'value': '122', 'spread': '36.6', 'groupId': 'BG000'}, {'value': '118.9', 'spread': '39.8', 'groupId': 'BG001'}, {'value': '120.44', 'spread': '38.18', 'groupId': 'BG002'}]}]}, {'title': 'External rotation 90 degrees abduction', 'categories': [{'measurements': [{'value': '61.0', 'spread': '34.8', 'groupId': 'BG000'}, {'value': '61.6', 'spread': '31.8', 'groupId': 'BG001'}, {'value': '61.3', 'spread': '33.23', 'groupId': 'BG002'}]}]}, {'title': 'Internal rotation with 90 degrees abduction', 'categories': [{'measurements': [{'value': '30.8', 'spread': '19.1', 'groupId': 'BG000'}, {'value': '33.3', 'spread': '17.8', 'groupId': 'BG001'}, {'value': '32.08', 'spread': '18.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measured flexion, abduction, external rotation in 90 degrees abduction \\[ER(90)\\], internal rotation in 90 degrees abduction \\[IR(90)\\], horizontal adduction, scaption, degrees with a goniometer by the same tester throughout', 'unitOfMeasure': 'degrees', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Western Ontario Rotator Cuff Index (WORC)', 'classes': [{'categories': [{'measurements': [{'value': '38.9', 'spread': '18.5', 'groupId': 'BG000'}, {'value': '40.6', 'spread': '17.2', 'groupId': 'BG001'}, {'value': '39.75', 'spread': '17.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'a 5-part (physical symptoms, sports/recreation, work, lifestyle, emotions) 21-item disease specific questionnaire. Measured in percentage. 0% = worst, 100 % = best', 'unitOfMeasure': 'percentage', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pain scale (Visual Analogue)', 'classes': [{'title': 'pain at rest', 'categories': [{'measurements': [{'value': '3.1', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '2.9', 'spread': '2.4', 'groupId': 'BG001'}, {'value': '3.0', 'spread': '2.34', 'groupId': 'BG002'}]}]}, {'title': 'pain with activity', 'categories': [{'measurements': [{'value': '6.1', 'spread': '2.4', 'groupId': 'BG000'}, {'value': '5.7', 'spread': '2.4', 'groupId': 'BG001'}, {'value': '5.88', 'spread': '2.39', 'groupId': 'BG002'}]}]}, {'title': 'pain at night', 'categories': [{'measurements': [{'value': '4.8', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '4.3', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '4.57', 'spread': '2.68', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Shoulder pain at rest, with activity and at night were measured using a visual analogue scale of 0-10 (no pain to severe pain)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Strength (dynamometer microFIT3)', 'classes': [{'title': 'flexion', 'categories': [{'measurements': [{'value': '19.2', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '20.1', 'spread': '12.3', 'groupId': 'BG001'}, {'value': '19.66', 'spread': '11.6', 'groupId': 'BG002'}]}]}, {'title': 'abduction', 'categories': [{'measurements': [{'value': '18.0', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '18.0', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '18.0', 'spread': '9.7', 'groupId': 'BG002'}]}]}, {'title': 'External rotation in abduction', 'categories': [{'measurements': [{'value': '11.2', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '11.9', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '11.54', 'spread': '8.8', 'groupId': 'BG002'}]}]}, {'title': 'internal rotation in abduction', 'categories': [{'measurements': [{'value': '17.6', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '19.4', 'spread': '14.0', 'groupId': 'BG001'}, {'value': '18.53', 'spread': '13.21', 'groupId': 'BG002'}]}]}, {'title': 'horizontal adduction', 'categories': [{'measurements': [{'value': '17.4', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '20.2', 'spread': '13.3', 'groupId': 'BG001'}, {'value': '18.8', 'spread': '12.6', 'groupId': 'BG002'}]}]}, {'title': 'scaption', 'categories': [{'measurements': [{'value': '13.99', 'spread': '6.92', 'groupId': 'BG000'}, {'value': '14.14', 'spread': '7.55', 'groupId': 'BG001'}, {'value': '14.07', 'spread': '7.23', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'strength was measured in pounds of force using a dynamometer (microFET3, Hoggan Health Industries, West Jordan, UT). Isometric shoulder flexion, abduction, were measured with the arm in neutral abduction and elbow at 90 degrees flexion. External and internal rotation were measured in 90 degrees of abduction. Peak values were recorded during each contraction which was held for 3 seconds. Values were expressed as raw values as well as proportional to the unaffected shoulder.', 'unitOfMeasure': 'pounds', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Short-Form 36-Item Health Survey (SF-36)', 'classes': [{'title': 'physical functioning', 'categories': [{'measurements': [{'value': '72.1', 'spread': '15.8', 'groupId': 'BG000'}, {'value': '71.7', 'spread': '16.3', 'groupId': 'BG001'}, {'value': '71.87', 'spread': '16.02', 'groupId': 'BG002'}]}]}, {'title': 'role physical', 'categories': [{'measurements': [{'value': '33.5', 'spread': '39.2', 'groupId': 'BG000'}, {'value': '35.7', 'spread': '36.8', 'groupId': 'BG001'}, {'value': '34.59', 'spread': '37.96', 'groupId': 'BG002'}]}]}, {'title': 'Bodily pain', 'categories': [{'measurements': [{'value': '44.7', 'spread': '17.2', 'groupId': 'BG000'}, {'value': '46.7', 'spread': '18.9', 'groupId': 'BG001'}, {'value': '45.67', 'spread': '18.03', 'groupId': 'BG002'}]}]}, {'title': 'general health', 'categories': [{'measurements': [{'value': '78.8', 'spread': '15.8', 'groupId': 'BG000'}, {'value': '76.0', 'spread': '17.6', 'groupId': 'BG001'}, {'value': '77.39', 'spread': '16.74', 'groupId': 'BG002'}]}]}, {'title': 'vitality', 'categories': [{'measurements': [{'value': '61.0', 'spread': '20.7', 'groupId': 'BG000'}, {'value': '62.2', 'spread': '18.1', 'groupId': 'BG001'}, {'value': '61.62', 'spread': '19.4', 'groupId': 'BG002'}]}]}, {'title': 'social function', 'categories': [{'measurements': [{'value': '79.6', 'spread': '21.9', 'groupId': 'BG000'}, {'value': '76.1', 'spread': '22.1', 'groupId': 'BG001'}, {'value': '77.85', 'spread': '22.02', 'groupId': 'BG002'}]}]}, {'title': 'role emotional', 'categories': [{'measurements': [{'value': '78.6', 'spread': '37.3', 'groupId': 'BG000'}, {'value': '80.3', 'spread': '33.8', 'groupId': 'BG001'}, {'value': '79.45', 'spread': '35.51', 'groupId': 'BG002'}]}]}, {'title': 'mental health', 'categories': [{'measurements': [{'value': '78.4', 'spread': '15.1', 'groupId': 'BG000'}, {'value': '77.7', 'spread': '13.7', 'groupId': 'BG001'}, {'value': '78.08', 'spread': '14.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Quality of life questionnaire that looks at physical functioning, Role-physical, bodily pain, general health, vitality, social function, role-emotional, mental health on a scale of worst to best. It is scored between 0 (no disability) and 100(very disable).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Surgical Characteristics', 'classes': [{'title': 'Mean length of tear Anteroposterior', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '2.1', 'spread': '1.0', 'groupId': 'BG001'}, {'value': '2.1', 'spread': '1.04', 'groupId': 'BG002'}]}]}, {'title': 'Mean length of tear Mediolateral', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '1.9', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '1.9', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-13', 'studyFirstSubmitDate': '2011-04-08', 'resultsFirstSubmitDate': '2019-04-02', 'studyFirstSubmitQcDate': '2011-04-08', 'lastUpdatePostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-16', 'studyFirstPostDateStruct': {'date': '2011-04-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario Rotator Cuff Index (WORC)', 'timeFrame': 'Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months', 'description': 'a 5-part (physical symptoms, sports/recreation, work, lifestyle, emotions) 21-item disease specific questionnaire. Measured in percentage. 0% = worst, 100 % = best'}, {'measure': 'Range of Motion (ROM)', 'timeFrame': 'baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months', 'description': 'Measured flexion, abduction, external rotation in 90 degrees abduction \\[ER(90)\\], internal rotation in 90 degrees abduction \\[IR(90)\\], horizontal adduction, scaption, degrees with a goniometer by the same tester throughout'}], 'secondaryOutcomes': [{'measure': 'Strength', 'timeFrame': 'Baseline, 6 months, 12 months, 24 months', 'description': 'strength was measured in pounds of force using a dynamometer (microFET3, Hoggan Health Industries, West Jordan, UT). Isometric shoulder flexion, abduction, were measured with the arm in neutral abduction and elbow at 90 degrees flexion. External and internal rotation were measured in 90 degrees of abduction. Peak values were recorded during each contraction which was held for 3 seconds. Values were expressed as raw values.'}, {'measure': 'The Short Form (36) Health Survey', 'timeFrame': 'baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months', 'description': 'The Short Form (36) Health Survey is a quality of life questionnaire that looks at eight scales: physical functioning, Role-physical, bodily pain, general health, vitality, social function, role-emotional, mental health. Each scale ranges between 0 (completely disable) to 100 (completely able).'}, {'measure': 'Adverse Events', 'timeFrame': '2 weeks, 6 weeks, 3 months, 6months', 'description': 'The following complications were monitored throughout study:\n\n* Medical related: urinary, gastrointestinal, cardiac, pulmonary, metabolic\n* Surgical related: nerve injury, superficial or deep infection, dislocation, frozen shoulder, hematoma, biceps rupture, failure of tendon healing, dermatitis, reflex sympathetic dystrophy (RSD), persistent pain, re-injury.\n* Other\n\nThe surgeon responsible for the patient used clinical judgment to make a decision regarding if the complication was related or not to the treatment being tested (use or not of sling).'}, {'measure': 'Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months', 'timeFrame': 'baseline, 6 weeks, 3, 6, 12, 24 months', 'description': 'Shoulder pain at rest, with activity and at night were measured using a visual analogue scale of 0-10 (no pain to severe pain)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rotator Cuff Tear']}, 'descriptionModule': {'briefSummary': "Shoulder rotator cuff (RC) tears are a significant cause of pain and disability. Surgery is done to reconnect the torn RC tendon(s) to the bone. The goals of RC surgery are to decrease pain, and to increase range of motion (ROM) and strength. This is done arthroscopically; through a small incision in the patient's shoulder. After surgery, patients are usually placed in a sling for up to 6 weeks to protect the repaired shoulder tendons. During this time, ROM exercises are only done by using the un-operated arm for assistance. Voluntary or active shoulder movement is usually not permitted to allow the repaired tendons to heal. Unfortunately, some patients develop shoulder stiffness while wearing the sling, which can delay rehabilitation. Any delays in rehabilitation may result in reduced shoulder function, a slower return-to-work or daily activities, and may also impact the health care system, through increased use and cost of rehabilitation.\n\nThis study's purpose is to determine if patients can safely stop wearing their sling as early as pain and comfort allow following RC surgery. A total of 200 patients (100 per group) will be randomly assigned to one of two study groups:\n\nPatients in Group A (accelerated rehab) will wear their sling for comfort only following surgery. Self-assisted ROM exercises are allowed at any time. This means that patients may stop wearing their sling if pain and comfort allow, and start active movement for activities of daily living only.\n\nPatients in Group B (standard rehab) will wear their sling for 6 weeks. Like in group A, self-assisted ROM exercises are allowed at any time, but active movement will not be allowed until 6 weeks after surgery. Patients in both groups will be given the same self-assisted ROM exercises after surgery.\n\nPatients who agree to participate in the study will see their surgeon and the study physical therapist/research coordinator on 6 occasions (pre-surgery, 2 weeks, 6 weeks, 3, 6, 12 months post-surgery). Each visit will take about 30 minutes and will include a ROM assessment, strength assessment (as appropriate) and disease-specific quality of life questionnaires. Patients will also undergo an Ultrasound exam to verify that their RC repair is intact at 12-months. Differences in ROM, strength, questionnaire scores, RC integrity, and adverse events will be examined between the two groups. Differences will also be examined according to RC tear size and patient characteristics."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient is over 18 years of age\n2. Patient has attempted non-operative treatment (i.e. physical therapy consisting of progressive ROM, strengthening, and postural exercises)\n3. Patient has a full-thickness tear of the supraspinatus and/or infraspinatus, as confirmed by appropriate diagnostic imaging (MRI, Arthrogram, Ultrasound)\n\nExclusion Criteria:\n\n1. Patient has a full-thickness tear of the subscapularis and/or teres minor\n2. Patient has undergone previous RC surgery to the affected shoulder\n3. Patient has major joint trauma, infection, or avascular necrosis\n4. Patient has chronic dislocation, inflammation, or degenerative glenohumeral arthropathy\n5. Patient has evidence of significant cuff arthropathy (superior glenohumeral translation and/or acromial erosion, as diagnosed by diagnostic imaging)\n6. Patient has a psychiatric illness, cognitive impairment, or other health condition (i.e. visual impairment) which precludes informed consent or renders the patient unable to complete study questionnaires\n7. Patient has a major medical illness where life expectancy is less than 2 years\n8. Patient does not speak/read/understand English\n9. Patient has no fixed address or means of contact\n10. Surgeon or patient has decided to cancel surgery\n11. Surgeon concludes that an arthroscopic repair is not appropriate at time of surgery (based on RC tear characteristics or concomitant shoulder pathology)\n12. Patient unwilling to complete necessary follow-ups'}, 'identificationModule': {'nctId': 'NCT01333527', 'briefTitle': 'Early Mobilization Following Arthroscopic Rotator Cuff Repair', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Early Mobilization Following Arthroscopic Rotator Cuff Repair: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RES0005824'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (early ROM)', 'description': 'Group A (early ROM) will use the sling for comfort only', 'interventionNames': ['Procedure: No Sling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (usual care)', 'description': 'Group B (usual care) will be immobilized in a sling for 6 weeks.', 'interventionNames': ['Procedure: Sling']}], 'interventions': [{'name': 'No Sling', 'type': 'PROCEDURE', 'description': 'Early range of motion', 'armGroupLabels': ['Group A (early ROM)']}, {'name': 'Sling', 'type': 'PROCEDURE', 'description': 'Patients will use the sling for 6 weeks, as per usual care', 'armGroupLabels': ['Group B (usual care)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2H9', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Glen Sather Sports Medicine clinic', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'David Sheps, MD,MSc,FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}