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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02371928 |
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Date of registration:
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09/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Neuromuscular Exercise Program for Patients With Anterior Shoulder Instability
SINEX |
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Scientific title:
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A Neuromuscular Exercise Program for Patients With Anterior Shoulder Instability: A Randomized Controlled Trial |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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56 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02371928 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Sten Rasmussen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Clinical Medicine, Aalborg University, Aalborg, Denmark |
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Name:
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Birgit Juul-Kristensen, Ass. Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark |
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Name:
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Lars H Frich, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shoulder sector, Orthopaedic Department, Odense University Hospital, Denmark |
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Name:
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Steen L Jensen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shoulder sector, Orthopedic Department, Aalborg University Hospital, Farsø Hospital, Denmark |
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Name:
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Henrik Eshoj, PhD-student |
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Address:
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Telephone:
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Email:
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Affiliation:
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Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark |
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Name:
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Karen Søgaard, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Research Unit for Physical Activity and Health in Working Life, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age between 18-39
2. Minimum one radiographic verified anterior shoulder dislocation (total dissociation of
the humeral head to the glenoid)
3. Limited ability to maintain a desired level of physical activity (sports/leisure/work)
due to pain and/or symptoms in the affected shoulder within the latest week.
Exclusion Criteria:
1. Humeral fracture and/or bony bankart (visible on conventional radiographs at the time
of presentation) warranted for surgery decided by the orthopedic (no other axial or
appendicular musculoskeletal injury)
2. Prior surgery in affected shoulder joint
3. >5 anterior shoulder dislocations (verified by journal or subjective evaluation)
4. Suspected competing diagnosis (e.g. rheumatoid arthritis, cancer, neurological
disorders, fibromyalgia, schizophrenia, suicidal threatened, borderline personality
disorder or obsessive compulsive disorder
5. Sensory and motor deficits in neck and shoulder
6. Pregnancy
7. Inadequacy in written and spoken Danish
8. Not willing or able to attend 12 weeks of supervised exercise therapy
Age minimum:
18 Years
Age maximum:
39 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Musculoskeletal Diseases
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Shoulder Dislocation
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Intervention(s)
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Other: Neuromuscular exercise program
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Other: Standard home exercise program
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Primary Outcome(s)
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Change in Western Ontario Shoulder Instability Index (WOSI)
[Time Frame: Primary: 3 months. Other: 12, 24 months]
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Secondary Outcome(s)
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Number of changes in positive clinical tests for anterior shoulder instability
[Time Frame: 3 months]
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Number of participants with adverse events
[Time Frame: 3 months]
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Change in Euro Qol 5D Index (EQ-5D)
[Time Frame: 3,12, 24 months]
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Change in shoulder joint position sense
[Time Frame: 3 months]
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Global Perceived Effect
[Time Frame: 3 months]
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Change in Constant-Murley Shoulder Score
[Time Frame: 3 months]
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Change in Tampa Scale of Kinesiophobia
[Time Frame: 3,12, 24 months]
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Change in the four sub-scales (domains) of WOSI
[Time Frame: 3,12, 24 months]
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Change in Patient Specific Functioning Scale
[Time Frame: 3 months]
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Secondary ID(s)
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S-20140093
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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