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NCT02620579 · ClinicalTrials.gov registry record · Phase 2
Biopsychosocial Influence on Shoulder Pain
A Phase 2 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 264
- Enrollment target
NCT02620579: Completed Phase 2 study, sponsored by Duke University.
NCT02620579 is a Phase 2 study that has completed, run by Duke University. The registered enrollment target is 264 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02620579, a Phase 2 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 264 participants
- Enrollment target
Study Summary
Chronic shoulder pain is a common, costly, and disabling problem for society. The identification of factors predictive of the development of chronic shoulder pain is necessary to develop innovative and effective treatments to reduce the societal impact of shoulder disorders. In previous work the investigators identified a genetic and psychological subgroup that robustly predicted heightened shoulder pain responses in a pre-clinical cohort and poor 12 month shoulder pain recovery rates in a clinical surgical cohort. In this follow-up study the investigator proposes to test how interventions tailored to the high risk subgroup affect pain responses in a pre-clinical cohort. The optimal theorized match for the identified high-risk subgroup is a combination of personalized pharmaceutical and education interventions. This combined personalized intervention versus a placebo pharmaceutical and general education intervention group is the primary comparison of interest. Also, an evaluation of the individual effect of personalized pharmaceutical and educational interventions will be part of the study. Such comparisons will provide important information on what the active portion of the combined personalized intervention may be.
Primary Outcome
The outcome has a range between 0 and 1, the higher scores mean a better outcome. Successful recovery was determined based on meeting the recovery criterion for shoulder pain intensity by at least 6 days. Specifically, recovery (Yes or No) was defined using Brief Pain Inventory (BPI) ratings as a current pain intensity rating of 0/10 and a worst pain intensity rating of less than 2/10.
Interventions
- DRUG Placebo
- DRUG Propranolol LA (60 mg)
- BEHAVIORAL Shoulder Anatomy Education
- BEHAVIORAL Pain Processing Education
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 264 participants |
| Start Date | 2016-01 |
| Est. Completion | 2021-11-05 |
| Phase | Phase 2 |
What the finished NCT02620579 record still lists
NCT02620579 is an interventional study that assigns participants to a tested intervention. The registered 264 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02620579 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02620579 about?
NCT02620579 is a clinical study titled "Biopsychosocial Influence on Shoulder Pain". Chronic shoulder pain is a common, costly, and disabling problem for society. The identification of factors predictive of the development of chronic shoulder pain is necessary to develop innovative and effective treatments to reduce the societal impact of shoulder disorders. In previous work the inv...
What is the current status of trial NCT02620579?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 264 participants. The study started on 2016-01. Estimated completion is 2021-11-05.
What interventions are being tested in trial NCT02620579?
The interventions under investigation include: Placebo (DRUG), Propranolol LA (60 mg) (DRUG), Shoulder Anatomy Education (BEHAVIORAL), Pain Processing Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT02620579?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02620579's enrollment target sits among peer trials
264 210th of 2000 higher than 1,791 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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