Pain, Postoperative Clinical Trial
— COPEOfficial title:
Cognitive Behavioral Therapy to Optimize Post-Operative Recovery (COPE): A Randomized Controlled Trial
Verified date | March 2024 |
Source | McMaster University |
Contact | Paula McKay |
Phone | 289-237-0791 |
mckayp[@]mcmaster.ca | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Psychological factors such as stress, distress, anxiety, depression, and poor coping strategies may be associated with ongoing pain following injuries such as fractures. To study this relationship, patients will undergo cognitive behavioural therapy (CBT) which is designed to modify such thoughts with the goal of reducing ongoing pain and improving quality of life. The goal of this study is to determine if CBT, versus usual care, reduces the prevalence of moderate to severe persistent post-surgical pain (PPSP) over 12-months post-fracture in patients with an open or closed fracture of the appendicular skeleton, treated with internal fixation.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | August 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult men or women aged 18 years and older. - Presenting to fracture clinic within 2-12 weeks following an acute open or closed fracture of the appendicular skeleton. Patients with multiple fractures may be included. - Fracture treated operatively with internal fixation. - Willing to participate in CBT. - Language skills and cognitive ability required to participate in CBT (in the judgement of site research personnel). - Consistent access to a smart phone and/or tablet that is capable of running the CBT provider's application. - Provision of informed consent. Exclusion Criteria: - Fragility fracture. - Stress fracture. - Concomitant injury which, in the opinion of the attending surgeon, is likely to impair function for as long as or longer than the patient's extremity fracture. - Among patients who are fully weightbearing, those not experiencing any pain in the fracture region. - Active psychosis. - Active suicidality. - Active substance use disorder that, in the judgement of the treating surgeon, would interfere in the patient's ability to partake in the CBT and/or the trial. - Already participating in, or planning to, start other psychological treatments (including CBT) within the duration of the study (12 months). - Anticipated problems, in the judgement of study personnel, with the patient participating in CBT intervention and/or returning for follow-up. - Incarceration. - Currently enrolled in a study that does not permit co-enrolment in other trials. - Previously enrolled in the COPE trial. - Other reason to exclude the patient, as approved by the Methods Centre. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary - Foothills Hospital | Calgary | Alberta |
Canada | Hamilton Health Sciences - General Site | Hamilton | Ontario |
Canada | Ottawa Civic Hospital | Ottawa | Ontario |
Canada | Memorial University Newfoundland | St. John's | Newfoundland and Labrador |
United States | University of Maryland - R Adams Cowley Shock Trauma Center | Baltimore | Maryland |
United States | Beth Israel Deaconess Medical Centre | Boston | Massachusetts |
United States | PRISMA Health | Greenville | South Carolina |
United States | PRISMA Health | Greenwood | South Carolina |
United States | Indiana University Health Methodist Hospital | Indianapolis | Indiana |
United States | University of Maryland - Capital Region Medical Center | Largo | Maryland |
United States | Dartmouth-Hitchcock Medical Centre | Lebanon | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Canadian Institutes of Health Research (CIHR), Orthopaedic Trauma Association |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The prevalence of moderate to severe Persistent Post-Surgical Pain at 12 months' post-fracture | The primary outcome is PPSP according to the World Health Organization's (WHO) proposed definition.
The WHO's definition requires 4 criteria for the diagnosis of PPSP: 1) Pain that began after surgery or a tissue trauma is experienced; 2) The pain is in an area of preceding surgery or tissue trauma, 3) The pain persisted for at least three months after the initiating event, and 4) The pain is not better explained by an infection, a malignancy, a pre-existing pain condition or any other alternative cause. |
12 months post-fracture | |
Secondary | Short Form 36 (SF-36) | General health related quality of life will be assessed by the SF-36. The SF-36 is an established, reliable and validated health status measure. It is a self-administered, 36-item questionnaire that measures health-related quality of life in 8 domains related to physical, social, mental, and emotional functioning, bodily pain, and general health. Both physical and mental summary scores can be obtained. Each domain is scored separately from 0 (lowest level) to 100 (highest level). | 12 months post-fracture | |
Secondary | Return to Function Questionnaire | Return to function will be measured by when participants' return to work, household activities, and leisure activities, as well as when they achieve 80% of their pre-injury function. The return to function outcome will be assessed using the Return to Function questionnaire. | 12 months post-fracture | |
Secondary | Brief Pain Inventory-Short Form (BPI-SF) | The Brief Pain Inventory (BPI) assess pain severity and its impact on function. Participants will rate their pain on a scale from 0-10 (0 being No Pain, and 10 being Pain as bad as you can imagine). Participants will also rate how pain has interfered with their every day life on a scale from 0-10 (0 being Does not interfere, and 10 being Completely Interferes). | 12 months post-fracture | |
Secondary | Opioid Use | Patient-reported use of opioid class medications. To determine if CBT versus usual care reduces the proportion of participants taking opioid class medications at 6 months and 12 months. | 12 months post-fracture |
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