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

Study Overview
=================
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).

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

Conditions
-----------------
Rotator Cuff Impingement Syndrome, Rotator Cuff Injury, Shoulder Pain

Intervention / Treatment
-----------------
* Behavioral: Patient Engagement Education and Restructuring of Cognitions


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Impairment Based Treatment<br>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<br>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<br>* 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.<br>|

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 |