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

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03353272
• Other study ID #: Pro00088013
• Status: Completed
• Phase: N/A
• Start date: September 18, 2018
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Rotator Cuff Impingement Syndrome
• Rotator Cuff Injuries
• Rotator Cuff Injury
• Shoulder Impingement Syndrome
• Shoulder Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Duke Sports Science Institute	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall Satisfaction with Care	Patients will be asked to rate their satisfaction of care as "excellent" "good" "fair" or "poor"	6 months