Rotator Cuff Impingement SyndromeNCT03353272
The Influence of a Cognitive Behavioral Approach on Changing Patient Expectations in Shoulder Pain
A study testing Patient Engagement Education and Restructuring of Cognitions in people with Rotator Cuff Impingement Syndrome and Rotator Cuff Injury, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rotator Cuff Impingement Syndrome, Rotator Cuff Injury, Shoulder Pain
- What is being tested?
- Patient Engagement Education and Restructuring of Cognitions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2018to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Sports Science Institute
Durham, North Carolina, 27710
About this study
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).
- Being tested
- Patient Engagement Education and Restructuring of Cognitions
- Medical subject headings
- Shoulder Impingement Syndrome, Rotator Cuff Injuries, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Engagement Education and Restructuring of CognitionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Impairment Based Treatment | No intervention | 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. |
| Impairment Based Treatment PLUS PEERC | Experimental | 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. Receives: Behavioral: Patient Engagement Education and Restructuring of Cognitions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pursuance of Surgical Intervention
The subject will be questioned if, after physical therapy, he or she will pursue surgery to address continued shoulder pain.
Measured: 6 Months
Secondary outcomes (9)
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.
Measured: Baseline, 6 weeks, Discharge (estimated 3 months)
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).
Measured: 6 weeks, Discharge (estimated 3 months)
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
Measured: Baseline, 6 weeks, Discharge (estimated 3 months)
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
Measured: Baseline, 3 weeks, 6 weeks, Discharge (estimated 3 months)
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)
Measured: Baseline, Discharge (estimated 3 months)
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
Measured: Baseline
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
Measured: Baseline
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
Measured: 6 months
Overall Satisfaction with Care
Patients will be asked to rate their satisfaction of care as "excellent" "good" "fair" or "poor"
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start18 Sep 2018
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad E Cook, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353272
- Sponsor's protocol ID
- Pro00088013
- Status last verified
- Nov 2022
- First submitted
- 21 Nov 2017
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Myers H, Keefe FJ, George SZ, Kennedy J, Lake AD, Martinez C, Cook CE. Effect of a Patient Engagement, Education, and Restructuring of Cognitions (PEERC) approach on conservative care in rotator cuff related shoulder pain treatment: a randomized control trial. BMC Musculoskelet Disord. 2023 Dec 1;24(1):930. doi: 10.1186/s12891-023-07044-y.
PubMed 38041042Myers 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.
PubMed 34429074
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of a Cognitive Behavioral Approach on Changing Patient Expectations in Shoulder Pain
- ClinicalTrials.gov ID
- NCT03353272
- Acronym / sponsor ID
- Pro00088013
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 27 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Impairment Based Treatment | No intervention | –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. |
| Impairment Based Treatment PLUS PEERC | Experimental | Behavioral: Patient Engagement Education and Restructuring of CognitionsParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Engagement Education and Restructuring of CognitionsThis 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. | Behavioural | Impairment Based Treatment PLUS PEERC |
Primary outcome
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.
9 secondary outcomes
Change in Pain
Time frame: Baseline, 6 weeks, Discharge (estimated 3 months)
Change in GRoC - Global rate of change
Time frame: 6 weeks, Discharge (estimated 3 months)
Change in SPADI - Shoulder Pain and Disability Index
Time frame: Baseline, 6 weeks, Discharge (estimated 3 months)
Change in MODEMS
Time frame: Baseline, 3 weeks, 6 weeks, Discharge (estimated 3 months)
Change in TEGNER
Time frame: Baseline, Discharge (estimated 3 months)
OSPRO 10 - Optimal Screening for Prediction of Referral and Outcome
Time frame: Baseline
Pain Catastrophizing Scale
Time frame: Baseline
SANE - Single Assessment Numeric Evaluation
Time frame: 6 months
Overall Satisfaction with Care
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Derived from this study: PubMed 38041042Myers H, Keefe FJ, George SZ, Kennedy J, Lake AD, Martinez C, Cook CE. Effect of a Patient Engagement, Education, and Restructuring of Cognitions (PEERC) approach on conservative care in rotator cuff related shoulder pain treatment: a randomized control trial. BMC Musculoskelet Disord. 2023 Dec 1;24(1):930. doi: 10.1186/s12891-023-07044-y.
- Derived from this study: PubMed 34429074Myers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad E Cook, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Engagement Education and Restructuring of Cognitions in people with Rotator Cuff Impingement Syndrome and Rotator Cuff Injury, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pursuance of Surgical Intervention (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03353272, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.