NCT03353272

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

Completed NA Last updated 21 March 2024

What this trial tests

NA trial testing Patient Engagement Education and Restructuring of Cognitions in Rotator Cuff Impingement Syndrome in 55 participants. Completed in 31 October 2022.

Timeline

18 September 2018

Primary endpoint
31 October 2022

31 October 2022

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	55
Start date	18 September 2018
Primary completion	31 October 2022
Estimated completion	31 October 2022
Sites	1 location across United States

Drugs / interventions tested

• Patient Engagement Education and Restructuring of Cognitions

Conditions studied

• Rotator Cuff Impingement Syndrome — all drugs for Rotator Cuff Impingement Syndrome →
• Rotator Cuff Injury — all drugs for Rotator Cuff Injury →
• Shoulder Pain — all drugs for Shoulder Pain →

Sponsor

Duke University

Who can join

Adults 18 to 70, any sex, with Rotator Cuff Impingement Syndrome or Rotator Cuff Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The influence of a cognitive behavioural approach on changing patient expectations for conservative care in shoulder pain treatment: a protocol for a pragmatic randomized controlled trial.
   Myers H, Keefe F, George SZ, Kennedy J, et al · · 2021 · cited 7× · PMID 34429074 · DOI 10.1186/s12891-021-04588-9
2. Effect of a Patient Engagement, Education, and Restructuring of Cognitions (PEERC) approach on conservative care in rotator cuff related shoulder pain treatment: a randomized control trial.
   Myers H, Keefe FJ, George SZ, Kennedy J, et al · · 2023 · cited 4× · PMID 38041042 · DOI 10.1186/s12891-023-07044-y