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

NCT ID: NCT03353272

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-18
• Study Completion Date: 2022-10-31

Brief 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).

Conditions

Rotator Cuff Impingement Syndrome; Rotator Cuff Injury; Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Impairment Based Treatment

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Impairment Based Treatment PLUS PEERC

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.

Group Type: EXPERIMENTAL

Patient Engagement Education and Restructuring of Cognitions

Intervention Type: BEHAVIORAL

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.

Interventions

Patient Engagement Education and Restructuring of Cognitions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chad E Cook, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Sports Science Institute

Durham, North Carolina, United States

Countries

United States

References

Myers H, Keefe FJ, George SZ, Kennedy J, Lake AD, Martinez C, Cook CE. 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. BMC Musculoskelet Disord. 2023 Dec 1;24(1):930. doi: 10.1186/s12891-023-07044-y.

Reference Type: DERIVED

PMID: 38041042 (View on PubMed)

Myers H, Keefe F, George SZ, Kennedy J, Lake AD, Martinez C, Cook C. 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. BMC Musculoskelet Disord. 2021 Aug 24;22(1):727. doi: 10.1186/s12891-021-04588-9.

Reference Type: DERIVED

PMID: 34429074 (View on PubMed)

Other Identifiers

Pro00088013

Identifier Type: -

Identifier Source: org_study_id