Clinical trial NCT03353272: The Influence of a Cognitive Behavioral Approach on Changing Patient Expectations in Shoulder Pain
Official title: The Influence of a Cognitive Behavioral Approach on Changing Patient Expectations in Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Impingement Syndrome
Rotator Cuff Injury
Shoulder Pain
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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).

Primary outcomes:
measure: Pursuance of Surgical Intervention
timeFrame: 6 Months
Secondary outcomes:
measure: Change in Pain
timeFrame: Baseline, 6 weeks, Discharge (estimated 3 months)
measure: Change in GRoC - Global rate of change
timeFrame: 6 weeks, Discharge (estimated 3 months)
measure: Change in SPADI - Shoulder Pain and Disability Index
timeFrame: Baseline, 6 weeks, Discharge (estimated 3 months)
measure: Change in MODEMS
timeFrame: Baseline, 3 weeks, 6 weeks, Discharge (estimated 3 months)
measure: Change in TEGNER
timeFrame: Baseline, Discharge (estimated 3 months)
measure: OSPRO 10 - Optimal Screening for Prediction of Referral and Outcome
timeFrame: Baseline
measure: Pain Catastrophizing Scale
timeFrame: Baseline
measure: SANE - Single Assessment Numeric Evaluation
timeFrame: 6 months
measure: Overall Satisfaction with Care
timeFrame: 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Sports Science Institute
state: North Carolina
Study officials:
affiliation: Duke University
name: Chad E Cook, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.