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

Duke University

Status: Completed

Conditions: Shoulder Pain; Rotator Cuff Injury; Rotator Cuff Impingement Syndrome

Treatments: Behavioral: Patient Engagement Education and Restructuring of Cognitions

Study type: Interventional

Funder types: Other

Identifiers

NCT03353272

Pro00088013

Details and patient eligibility

About

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).

Enrollment: 55 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 to 70
• A rotator cuff related shoulder pain diagnosis
• A mobile or land-line telephone
• Ability to read and write English for completion of the self-report forms.

Exclusion criteria

• The investigators will exclude patients who have received or are scheduled for a surgical intervention for their shoulder condition
• Demonstrate any evidence of cervicogenic pain and/or radiculopathy from cervical origin
• Who demonstrate symptoms consistent with thoracic outlet syndrome
• The investigators will also exclude individuals who are undergoing treatment for a serious psychological disorder (e.g., severe depression, psychosis).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 2 patient groups

Impairment Based Treatment

No Intervention group

Description:

an impairment-based conservative intervention that has been created by compiling the evidence associated with established, effective treatment interventions for rotator cuff related shoulder pain.

Impairment Based Treatment PLUS PEERC

Experimental group

Description:

Participants assigned to the impairment-based care plus PEERC condition will also receive the PEERC protocol. This protocol, informed by principles of CBT, involves three components: 1) engagement, 2) education and 3) cognitive restructuring and behavioral activation. A health coach who is responsible for engaging patients, educating them about pain modulatory mechanisms, and reinforcing cognitive and behavioral coping skills, will deliver the PEERC protocol.

Treatment:

Behavioral: Patient Engagement Education and Restructuring of Cognitions