search
Back to results

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

Primary Purpose

Rotator Cuff Impingement Syndrome, Rotator Cuff Injury, Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Engagement Education and Restructuring of Cognitions
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Impingement Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Duke Sports Science Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Impairment Based Treatment

Impairment Based Treatment PLUS PEERC

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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).
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
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
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)
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
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
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
Overall Satisfaction with Care
Patients will be asked to rate their satisfaction of care as "excellent" "good" "fair" or "poor"

Full Information

First Posted
November 21, 2017
Last Updated
November 11, 2022
Sponsor
Duke University
search

1. Study Identification

Unique Protocol Identification Number
NCT03353272
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 18, 2018 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Impingement Syndrome, Rotator Cuff Injury, Shoulder Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Impairment Based Treatment
Arm Type
No Intervention
Arm Description
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.
Arm Title
Impairment Based Treatment PLUS PEERC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient Engagement Education and Restructuring of Cognitions
Intervention Description
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 Outcome Measure Information:
Title
Pursuance of Surgical Intervention
Description
The subject will be questioned if, after physical therapy, he or she will pursue surgery to address continued shoulder pain.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Change in Pain
Description
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.
Time Frame
Baseline, 6 weeks, Discharge (estimated 3 months)
Title
Change in GRoC - Global rate of change
Description
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).
Time Frame
6 weeks, Discharge (estimated 3 months)
Title
Change in SPADI - Shoulder Pain and Disability Index
Description
The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability
Time Frame
Baseline, 6 weeks, Discharge (estimated 3 months)
Title
Change in MODEMS
Description
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
Time Frame
Baseline, 3 weeks, 6 weeks, Discharge (estimated 3 months)
Title
Change in TEGNER
Description
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)
Time Frame
Baseline, Discharge (estimated 3 months)
Title
OSPRO 10 - Optimal Screening for Prediction of Referral and Outcome
Description
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
Time Frame
Baseline
Title
Pain Catastrophizing Scale
Description
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
Time Frame
Baseline
Title
SANE - Single Assessment Numeric Evaluation
Description
The Single Assessment Numeric Evaluation (SANE) is a patient reported outcome measure utilized to rate the patient's perceived level of function
Time Frame
6 months
Title
Overall Satisfaction with Care
Description
Patients will be asked to rate their satisfaction of care as "excellent" "good" "fair" or "poor"
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chad E Cook, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Sports Science Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34429074
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs