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

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ClinicalTrials.gov Identifier: NCT03353272
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

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).


Condition or disease Intervention/treatment Phase
Rotator Cuff Impingement Syndrome Rotator Cuff Injury Shoulder Pain Behavioral: Patient Engagement Education and Restructuring of Cognitions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Influence of a Cognitive Behavioral Approach on Changing Patient Expectations in Shoulder Pain
Actual Study Start Date : September 18, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
No Intervention: Impairment Based Treatment
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
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
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 Measures :
  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.

  2. Pursuance of Surgical Intervention [ Time Frame: 3 Months ]
    The subject will be questioned if, after physical therapy, he or she will pursue surgery to address continued shoulder pain.


Secondary Outcome Measures :
  1. Change in Pain [ Time Frame: Baseline, 6 weeks, 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: Baseline, 6 weeks, 3 months ]
    The Global Rating of Change (GRoC)40 asks patients to report their global rating of change (GROC) relative to baseline in 3 categories: overall, in pain, and in physical function, using a 7-point ordinal scale (where -7 much worse and +7 much better).

  3. Change in PCS - Pain Catastrophizing Scale [ Time Frame: Baseline, 6 weeks, 3 months ]
    The PCS is a 12-item questionnaire ranking types of thoughts and feelings one has while in pain. Items are ranked from 0 (not at all) to 4 (all the time).

  4. Change in SPADI - Shoulder Pain and Disability Index [ Time Frame: Baseline, 6 weeks, 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

  5. Change in MODEMS [ Time Frame: Baseline, 6 weeks, 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Low pre-treatment expectations
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353272


Contacts
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Contact: Heather S Myers, DPT 9196811656 heather.myers@duke.edu

Locations
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United States, North Carolina
Duke Sports Science Institute Recruiting
Durham, North Carolina, United States, 27710
Contact: Heather Myers, DPT    919-681-1656    heather.myers@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Chad E Cook, PhD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03353272     History of Changes
Other Study ID Numbers: Pro00088013
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shoulder Impingement Syndrome
Shoulder Pain
Rotator Cuff Injuries
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries