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 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).

Study Overview

• Status: Completed
• Conditions: Shoulder Pain; Rotator Cuff Injury; Rotator Cuff Impingement Syndrome
• Intervention / Treatment: Behavioral: Patient Engagement Education and Restructuring of Cognitions

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Sports Science Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain	Numeric Pain Scale- The NRS for pain is scaled from 0 to 10 (11 point scale) and is based on pain intensity. Overall pain intensity will be queried where 0/10 represents no pain and 10/10 represents the worst pain possible.	Baseline, 6 weeks, Discharge (estimated 3 months)
Change in GRoC - Global rate of change	The Global Rating of Change (GRoC) asks patients to report their global rating of change (GROC) relative to physical function, using a 7-point ordinal scale (where -7 much worse and +7 much better).	6 weeks, Discharge (estimated 3 months)
Change in SPADI - Shoulder Pain and Disability Index	The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability	Baseline, 6 weeks, Discharge (estimated 3 months)
Change in MODEMS	The MODEMS patient expectation scale has been used by a number of studies and has shown validity in predicting outcomes in conservative and surgical interventions. As we previously stated, the instrument is a Likert-based scoring tool with a mean score of 5 out of 5 (indicating high expectations of positive outcomes) and a mean score of 1 out of 5 (indicating very poor expectations of positive outcomes)30	Baseline, 3 weeks, 6 weeks, Discharge (estimated 3 months)
Change in TEGNER	The Tegner Activity Scale measures the patient's perspective of function and activity as a numerical value between 0 (complete disability) to 10 (elite athletics)	Baseline, Discharge (estimated 3 months)
OSPRO 10 - Optimal Screening for Prediction of Referral and Outcome	Optimal Screening for Prediction of Referral and Outcome-10. The OSPRO is a review-of-systems screening tool that includes constructs associated with comorbidities, negative mood, quality of life, pain, and function	Baseline
Pain Catastrophizing Scale	The Pain Catastrophizing Scale (PCS) assesses the extent of catastrophic thinking according to 3 components: rumination, magnification, and helplessness. It is a 13-item scale	Baseline
SANE - Single Assessment Numeric Evaluation	The Single Assessment Numeric Evaluation (SANE) is a patient reported outcome measure utilized to rate the patient's perceived level of function	6 months
Overall Satisfaction with Care	Patients will be asked to rate their satisfaction of care as "excellent" "good" "fair" or "poor"	6 months

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Chad E Cook, PhD, Duke University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2018
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Arthralgia; Rotator Cuff Injuries; Shoulder Impingement Syndrome; Shoulder Pain
• Other Study ID Numbers: Pro00088013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No