An interventional study of Cognitive Behavioural Therapy in Pain, Postoperative, Pain, Acute and Pain, Chronic, sponsored by McMaster University. Completed at 10 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-05.
Sponsored by McMaster University · Not applicable, Interventional, and Prevention
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.
The relationship between psychological factors, behaviors, and cognitive processes and the sensation of pain is well documented. Stress, distress, anxiety, depression, catastrophizing, fear-avoidance behaviors, and poor coping strategies appear to have a significant positive relationship with both acute and chronic pain. Evidence suggests that these psychological factors can cause alterations along the spinal and supraspinal pain pathways which influence the perception of pain. Previous studies suggest that patients' beliefs and expectations may be associated with clinical outcomes, including self-reported pain. Previous studies in trauma patients have demonstrated patients' beliefs and expectations regarding their recovery following surgery are associated with functional limitations, lower rates of return to work, and reduced quality of life one year after injury. Furthermore, up to two thirds of patients with operative managed extremity fractures demonstrate unhelpful illness beliefs that increase risks of negative outcomes, including persistent pain. Psychological interventions, such as cognitive behavioural therapy (CBT), that are designed to modify unhelpful beliefs and behaviours have the potential to reduce persistent post-surgical pain and its associated effects among trauma patients.
Our primary objective is to determine if CBT, versus usual care, reduces the prevalence of moderate to severe PPSP over 12 months post-fracture in participants with an open or closed fracture of the appendicular skeleton. Our secondary objectives are to determine if CBT, versus usual care: 1) increases physical functioning, 2) improves mental functioning, 3) accelerates return to function, 4) reduces pain severity, and 5) reduces pain interference over 12 months post-fracture, and 6) reduces the proportion of participants prescribed opioid class medications at 6 and 12 months post-fracture. This trial is a multi-centre randomized controlled trial (RCT) of 1,000 participants with an open fracture of the appendicular skeleton or closed fracture of the lower extremity or pelvis treated with internal fixation.
Exclusion Criteria:
Participants in this arm will receive cognitive behavioural therapy (CBT). Participants will complete a series of online modules via a mobile application in addition to standard of care for their fracture injury. Participants will be assigned a dedicated CBT therapist, and receive feedback and support from their therapist via in-app messaging. The CBT program will last approximately 6-8 weeks.
Behavioral: Cognitive Behavioural Therapy
Participants in the control arm of the study will receive standard of care treatment for their fracture(s) but will not receive any Cognitive Behavioral Therapy.
Participants who are randomized to the CBT intervention will be encouraged to begin CBT immediately following randomization. The CBT intervention will focus on addressing maladaptive beliefs related to pain and recovery as well as teaching skills to enhance coping and management of pain symptoms. The specific focus of CBT sessions will be informed by each individual patient's responses to baseline questionnaires. All other aspects of post-operative care will be at the discretion of participant's surgeon.
Also known as: CBT
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.
Time frame: 12 months post-fracture
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).
Time frame: 12 months post-fracture
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.
Time frame: 12 months post-fracture
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).
Time frame: 12 months post-fracture
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.
Time frame: 12 months post-fracture
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