Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-03-02 @ 10:05 PM
Study NCT ID:
NCT02035618
Status:
COMPLETED
Last Update Posted:
2014-01-15
First Post:
2014-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercises Associated or Not With Manual Therapy Shoulder Impingement
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'lastUpdateSubmitDate': '2014-01-13', 'studyFirstSubmitDate': '2014-01-10', 'studyFirstSubmitQcDate': '2014-01-10', 'lastUpdatePostDateStruct': {'date': '2014-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scapular kinematics', 'timeFrame': 'up to 3 months from the initial interview'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Shoulder Impingement']}, 'referencesModule': {'references': [{'pmid': '26471852', 'type': 'DERIVED', 'citation': 'Camargo PR, Alburquerque-Sendin F, Avila MA, Haik MN, Vieira A, Salvini TF. Effects of Stretching and Strengthening Exercises, With and Without Manual Therapy, on Scapular Kinematics, Function, and Pain in Individuals With Shoulder Impingement: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2015 Dec;45(12):984-97. doi: 10.2519/jospt.2015.5939. Epub 2015 Oct 15.'}]}, 'descriptionModule': {'briefSummary': 'Manual therapy combined with a protocol of therapeutic exercises will increase the beneficial effects on scapular kinematics, myofascial pain and function in subjects with shoulder impingement when compared to exercises only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* history of non-traumatic onset of shoulder pain;\n* painful arc during active elevation of the arm;\n* one or more positive shoulder impingement tests (Neer, Hawkins and Jobe), or pain during passive or resisted external rotation of the arm at 90° of abduction;\n* pain with palpation of the rotator cuff tendons;\n* all subjects need also to be able to reach 150° of arm elevation as evaluated by visual observation.\n\nExclusion Criteria:\n\n* limitation of glenohumeral internal and external rotation as indicative of adhesive capsulitis;\n* body mass index \\> 28kg/m2 as the amount of subcutaneous tissue can compromise the quality of the signal increasing soft tissue artifact;\n* numbness or tingling of the upper limb reproduced by cervical compression test;\n* history of clavicle, scapula or humerus fracture;\n* history of rotator cuff surgery;\n* systemic illnesses;\n* positive sulcus or apprehension tests as indicative of instability;\n* positive drop arm test as indicative of full thickness tear;\n* corticosteroid injection within 3 months prior to intervention, or physiotherapy within 6 months prior to intervention;\n* depressive symptoms as evaluated by the Beck Depression Inventory score ( \\> 9 points) due to its influence on myofascial pain;\n* allergy to tape.'}, 'identificationModule': {'nctId': 'NCT02035618', 'briefTitle': 'Exercises Associated or Not With Manual Therapy Shoulder Impingement', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal de Sao Carlos'}, 'orgStudyIdInfo': {'id': 'UFSCar/CEP 270/2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercises and manual therapy', 'interventionNames': ['Other: Exercises', 'Other: Exercises + Manual Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercises', 'interventionNames': ['Other: Exercises']}], 'interventions': [{'name': 'Exercises', 'type': 'OTHER', 'description': 'Strengthening and stretching', 'armGroupLabels': ['Exercises', 'Exercises and manual therapy']}, {'name': 'Exercises + Manual Therapy', 'type': 'OTHER', 'description': 'Mobilization; massage; post-isometric relaxation; strengthening; stretching', 'armGroupLabels': ['Exercises and manual therapy']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal de Sao Carlos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PT, PhD', 'investigatorFullName': 'Paula Rezende Camargo', 'investigatorAffiliation': 'Universidade Federal de Sao Carlos'}}}}