Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
Study NCT ID:
NCT03521856
Status:
COMPLETED
Last Update Posted:
2022-09-16
First Post:
2018-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial for Shoulder Pathology and Pain in Chronic SCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-12', 'studyFirstSubmitDate': '2018-04-29', 'studyFirstSubmitQcDate': '2018-04-29', 'lastUpdatePostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in shoulder pathology', 'timeFrame': 'Baseline to week 12', 'description': 'Quantitative ultrasound measures of the supraspinatus tendon'}], 'secondaryOutcomes': [{'measure': 'Change in shoulder pain using the numerical rating scale', 'timeFrame': 'Baseline to week 12', 'description': 'Numerical rating scale for pain intensity (0 = no pain; 10 = most intense pain imaginable)'}, {'measure': 'Change in shoulder pain using the numerical rating scale', 'timeFrame': 'Baseline to week 16', 'description': 'Numerical rating scale for pain intensity (0 = no pain; 10 = most intense pain imaginable)'}, {'measure': 'Change in shoulder pain using the WUSPI', 'timeFrame': 'Baseline to week 12', 'description': 'Wheelchair Users Shoulder Pain Index (WUSPI) (0 - 150)'}, {'measure': 'Change in shoulder pain using the WUSPI', 'timeFrame': 'Baseline to week 16', 'description': 'Wheelchair Users Shoulder Pain Index (WUSPI) (0 - 150)'}, {'measure': 'Change in shoulder pathology', 'timeFrame': 'Baseline to week 16', 'description': 'Quantitative ultrasound measures of the supraspinatus tendon'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spinal cord injuries', 'SCI'], 'conditions': ['Shoulder Pain']}, 'referencesModule': {'references': [{'pmid': '21292803', 'type': 'BACKGROUND', 'citation': 'Mulroy SJ, Thompson L, Kemp B, Hatchett PP, Newsam CJ, Lupold DG, Haubert LL, Eberly V, Ge TT, Azen SP, Winstein CJ, Gordon J; Physical Therapy Clinical Research Network (PTClinResNet). Strengthening and optimal movements for painful shoulders (STOMPS) in chronic spinal cord injury: a randomized controlled trial. Phys Ther. 2011 Mar;91(3):305-24. doi: 10.2522/ptj.20100182. Epub 2011 Feb 3.'}, {'pmid': '31851011', 'type': 'RESULT', 'citation': 'Cardenas DD, Felix ER, Cowan R, Orell MF, Irwin R. Effects of Home Exercises on Shoulder Pain and Pathology in Chronic Spinal Cord Injury: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2020 Jun;99(6):504-513. doi: 10.1097/PHM.0000000000001362.'}]}, 'descriptionModule': {'briefSummary': 'This research study will investigate in a 12-week home exercise program to see whether it is effective in improving shoulder pathology and reducing shoulder pain in persons with chronic spinal cord injury. The research study will involve ultrasound shoulder examinations of your shoulders using a non-invasive medical ultrasound machine, as well as clinical shoulder examinations and completion of a number of pain questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Candidates will be men or women, 18 years of age or older.\n2. Candidates must have an SCI and be at least 1 year post-diagnosis\n3. Candidates must use a wheelchair (manual or electric) for at least the majority of the time.\n4. Candidates must be able to transfer themselves without the help of others.\n5. The presence of at least moderate shoulder pain (rating of \\>= 4 on a 0-10 rating scale for average pain intensity) for 3 or more months.\n\nExclusion Criteria:\n\n1. Patients younger than 18 years of age.\n2. Patients who have a history of pre-injury rotator cuff tears or shoulder injury.\n3. Patients who do not use a wheelchair (manual or electric) at least 50% of the time.'}, 'identificationModule': {'nctId': 'NCT03521856', 'briefTitle': 'Trial for Shoulder Pathology and Pain in Chronic SCI', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Trial for Shoulder Pathology and Pain in Chronic SCI', 'orgStudyIdInfo': {'id': '20111005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'shoulder exercise intervention', 'description': 'A home exercise intervention for strengthening and stretching the shoulders - Strengthening and Optimal Movement for Painful Shoulders (STOMPS) - performed 3 times per week for 12 weeks.', 'interventionNames': ['Behavioral: shoulder exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'education-only control', 'description': 'Subjects watched a 1 hour educational video on shoulder anatomy, mechanisms of shoulder injury and pain, and hints for managing shoulder pain', 'interventionNames': ['Behavioral: education']}], 'interventions': [{'name': 'shoulder exercise', 'type': 'BEHAVIORAL', 'description': 'Exercises performed 3 times a week for 12 weeks', 'armGroupLabels': ['shoulder exercise intervention']}, {'name': 'education', 'type': 'BEHAVIORAL', 'armGroupLabels': ['education-only control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Elizabeth R Felix, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'U.S. Department of Education', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Elizabeth Roy Felix', 'investigatorAffiliation': 'University of Miami'}}}}