Skip to main content
OpenTrials
Completed

NCT Number: NCT03353272

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rotator Cuff Impingement Syndrome Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rotator Cuff Injuries Rotator Cuff Injury Rupture Shoulder Impingement Syndrome Shoulder Injuries Shoulder Pain Signs and Symptoms Tendon Injuries Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Sports Science Institute

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Pursuance of Surgical Intervention

    Time frame: 6 Months

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

Secondary outcomes

  1. Change in Pain

    Time frame: Baseline, 6 weeks, Discharge (estimated 3 months)

    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.

  2. Change in GRoC - Global rate of change

    Time frame: 6 weeks, Discharge (estimated 3 months)

    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).

  3. Change in SPADI - Shoulder Pain and Disability Index

    Time frame: Baseline, 6 weeks, Discharge (estimated 3 months)

    The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability

  4. Change in MODEMS

    Time frame: Baseline, 3 weeks, 6 weeks, Discharge (estimated 3 months)

    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

  5. Change in TEGNER

    Time frame: Baseline, Discharge (estimated 3 months)

    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)

  6. OSPRO 10 - Optimal Screening for Prediction of Referral and Outcome

    Time frame: Baseline

    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

  7. Pain Catastrophizing Scale

    Time frame: Baseline

    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

  8. SANE - Single Assessment Numeric Evaluation

    Time frame: 6 months

    The Single Assessment Numeric Evaluation (SANE) is a patient reported outcome measure utilized to rate the patient's perceived level of function

  9. Overall Satisfaction with Care

    Time frame: 6 months

    Patients will be asked to rate their satisfaction of care as "excellent" "good" "fair" or "poor"

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Nov 27, 2017
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.