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

NCT03353272 | Completed

• 1 other identifier: Pro00088013
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pursuance of Surgical Intervention

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

  6 Months

Secondary Outcomes (9)

• Change in Pain

  Baseline, 6 weeks, Discharge (estimated 3 months)

• Change in GRoC - Global rate of change

  6 weeks, Discharge (estimated 3 months)

• Change in SPADI - Shoulder Pain and Disability Index

  Baseline, 6 weeks, Discharge (estimated 3 months)

• Change in MODEMS

  Baseline, 3 weeks, 6 weeks, Discharge (estimated 3 months)

• Change in TEGNER

  Baseline, Discharge (estimated 3 months)

Study Arms (2)

Impairment Based Treatment

NO INTERVENTION

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

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.

Behavioral: Patient Engagement Education and Restructuring of Cognitions

Interventions

Patient Engagement Education and Restructuring of Cognitions 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.

Impairment Based Treatment PLUS PEERC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Sports Science Institute

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

• 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.

  PMID: 38041042 DERIVED

• 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.

  PMID: 34429074 DERIVED

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Rotator Cuff Injuries; Shoulder Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chad E Cook, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 27, 2017
• Study Start: September 18, 2018
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: March 21, 2024

Record last verified: 2022-11

Locations

US (1)