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NCT03353272 · ClinicalTrials.gov registry record · NA

The Influence of a Cognitive Behavioral Approach on Changing Patient Expectations in Shoulder Pain

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
55
Enrollment target

NCT03353272: Completed NA study, sponsored by Duke University.

NCT03353272 is a NA study that has completed, run by Duke University. The registered enrollment target is 55 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03353272, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
55 participants
Enrollment target

Study Summary

Background: Despite similar treatment outcomes for surgery or conservative care, the number of surgeries for the care of rotator cuff (RTC) related shoulder pain has increased. With the increase in surgery, there is an increased risk of harms, increased costs, and high re-tear rates. Patient expectations are beliefs or attitudes that include pre-treatment thoughts and beliefs regarding the need for specific treatment methods and the timing and intensity of these methods. Brief interventions designed to alter and enhance treatment expectations for conservative care and have been shown to improve patient expectations, but to date, no studies have explored whether such interventions can influence patient decisions to pursue surgical care. The investigators propose a comprehensive intervention that involves Patient Engagement Education, and Restructuring of Cognitions (PEERC) that is designed to change expectations, will reduce the likelihood that patients will choose to have shoulder surgery and improve functional outcomes. The cognitive behavioral therapy (CBT) approaches that form the core of our PEERC protocol are patient-centered and are designed to empower the patient in their own recovery process. Purpose/Aims: To examine the effect of the PEERC protocol on the decision to have surgery (primary), and improve global well-being, pain catastrophizing, pain, functional outcomes, and follow up expectations (secondary).

Primary Outcome

The subject will be questioned if, after physical therapy, he or she will pursue surgery to address continued shoulder pain.

Interventions

  • BEHAVIORAL Patient Engagement Education and Restructuring of Cognitions

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2018-09-18
Est. Completion 2022-10-31
Phase NA
Duke University

1,725 total trials

What the finished NCT03353272 record still lists

NCT03353272 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which Patient Engagement Education and Restructuring of Cognitions is the first listed.

NCT03353272 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03353272 about?

NCT03353272 is a clinical study titled "The Influence of a Cognitive Behavioral Approach on Changing Patient Expectations in Shoulder Pain". Background: Despite similar treatment outcomes for surgery or conservative care, the number of surgeries for the care of rotator cuff (RTC) related shoulder pain has increased. With the increase in surgery, there is an increased risk of harms, increased costs, and high re-tear rates. Patient expecta...

What is the current status of trial NCT03353272?

This trial is currently completed. It is a NA study. The enrollment target is 55 participants. The study started on 2018-09-18. Estimated completion is 2022-10-31.

What interventions are being tested in trial NCT03353272?

The interventions under investigation include: Patient Engagement Education and Restructuring of Cognitions (BEHAVIORAL).

Who is sponsoring clinical trial NCT03353272?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03353272's enrollment target sits among peer trials

55 1264th of 2000 higher than 733 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT03353272, the US trial registry maintained by the National Library of Medicine. NCT03353272 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.