Efficacy of First Time Anterior Shoulder Decision Tool
NCT02656277 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210
Last updated 2017-01-31
Summary
This study is a randomized controlled trial using Duke patients to test, compared to the standard of care, a questionnaire and statistical model used to determine how patient preference regarding shoulder pain, physical limitations, physical therapy, recovery period, prognosis, and cost impact choice of surgical versus non-surgical intervention.
Phase 1 of this study is the initial testing of the instrument and involves a small group of up to 10 individuals who will partake in one-on-one interviews while completing the Shoulder Injury Survey to provide feedback. In Phase 2 of this study, 200 subjects will be randomized to receive either the Decision Tool or the standard Information on Shoulder Dislocation
Conditions
- Shoulder Dislocation
Interventions
- OTHER
-
Decision Tool
- OTHER
-
Information on Shoulder Dislocation
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Richard Mather, MD · Duke University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-01-31
- Primary Completion
- 2016-12-31
- Completion
- 2016-12-31
Countries
- United States
Study Locations
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