Clinical trial NCT03196258: Cognitive Behavioural Therapy to Reduce Persistent Post-Surgical Pain After Fracture
Official title: Cognitive Behavioural Therapy to Improve Outcomes of High Risk Patients Following Internal Fixation of Extremity Fractures: A Randomized Controlled Trial (SPOC-CBT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain, Postoperative
Fractures, Closed
Fractures, Open
Keywords: fracture
persistent pain
cognitive behavioural therapy
post surgical pain
health-related quality of life
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Hamilton Academic Health Sciences Organization
name: Hamilton Health Sciences Corporation
name: Unity Health Toronto
First posted: 2017-06-22
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants with operatively managed extremity fractures who screen positive for unhelpful illness beliefs (SPOC scores ≥78) 6-weeks post-fracture fixation will be randomized to receive either 6 weekly one-on-one, 1-hour sessions of cognitive behavioral therapy (CBT) or standard of care (control). Outcomes will be assessed at 3 months, 6 months, 9 months, and 12 months' post-fracture
Primary purpose: PREVENTION

Brief summary: Psychological factors such as stress, distress, anxiety, depression, and poor coping strategies may be associated with ongoing pain following injuries such as fractures. In order to study this relationship, researchers at McMaster University have developed the Somatic Pre-Occupation and Coping (SPOC) questionnaire, which identifies illness beliefs that may help to predict which patients are at risk for ongoing pain, reduced quality of life, and delays in returning to work and leisure activities after a fracture requiring surgical treatment. Previous research using the SPOC questionnaire suggests the possibility that fracture patients with illness beliefs that put them at risk for developing ongoing pain could be identified early in the treatment process. These patients may benefit from 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 is effective in reducing ongoing pain and improving quality of life in fracture patients who show illness beliefs that may place them at risk for developing ongoing pain.

Detailed description: In North America, chronic non-cancer pain affects approximately 30% of the population, with similar rates in Europe and Australia. Surgery and trauma are frequently cited as triggering events responsible for the development of chronic pain. A survey of 5,130 patients attending 10 outpatient clinics located throughout North Britain found that 41% attributed their chronic pain to a traumatic event or surgery. The presence of persistent pain can have a major impact on patients' quality of life, including their ability to return to work and their daily activities.

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.

Clinical outcomes following operatively managed fractures of the extremities are variable and many patients continue to experience persistent pain and disability one-year after surgery and beyond. In a recent trial involving patients with open extremity fractures, 65% of patients reported moderate to very severe pain and 35% reported moderate to extreme pain interference at one-year. A systematic review of 20 observational studies of traumatic tibial fracture repairs found the mean incidence of persistent post-surgical pain (PPSP) was 47.4% (range: 10% to 86%) at an average of 23.9 months after surgery. Although several risk factors for PPSP have been identified, many, such as younger age and female gender, are non-modifiable and thus not amendable to direct intervention.

The effect of patients' beliefs and expectations on their recovery following traumatic injuries is an under-investigated area. In response to this gap, Busse et al. developed and evaluated the Somatic Pre-Occupation and Coping (SPOC) questionnaire to identify unhelpful illness beliefs that are predictive of poorer functional outcomes post-fracture. This self-administered questionnaire identified unhelpful illness beliefs among approximately one third of patients with operatively managed extremity fractures. Furthermore, high somatic pre-occupation and poor coping at 6-weeks post-fracture (as measured by the SPOC questionnaire) were found to be strongly associated with PPSP, functional limitations, unemployment, and reduced quality of life 1 year after fracture fixation. This suggests the possibility that fracture patients who exhibit unhelpful illness beliefs can be identified and targeted for concurrent therapy designed to modify such cognitions and improve prognosis. At present, however, there are no approaches that have been shown effective for improving recovery among high-risk patients.

The findings from the FLOW trial highlight the importance of patient beliefs in recovery from orthopaedic trauma. A number of systematic reviews have shown patients' perceptions regarding their illness experience can be modified, and that such efforts can improve outcomes. Moss-Morris and colleagues explored the effect of CBT among patients attending a multidisciplinary chronic pain clinic and found that changes in cognitive processes accounted for 26% of the variation in improved health-related quality of life scores. Collectively, these findings suggest that targeting and modifying unhelpful beliefs through CBT may provide an effective strategy to improve outcomes among high-risk trauma patients.

Eligibility criteria: The inclusion criteria are:

1. Adult men or women aged 18 years and older.
2. Acute open or closed fracture(s) of the appendicular skeleton. Patients with multiple fractures may be included.
3. Fracture treated operatively with internal fixation.
4. Screened for eligibility within 6 weeks of their fracture.
5. Cognitive ability and language skills required to participate in the CBT intervention (in the judgement of site research personnel).
6. Able to start the CBT within 8 weeks of their fracture surgery.
7. Provision of informed consent.
8. Screen positive for unhelpful illness beliefs (SPOC scores ≥74), as assessed at 6 weeks' post-surgical fixation.

The exclusion criteria are:

1. Fragility fracture.
2. Stress fracture.
3. 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.
4. Active psychosis.
5. Active suicidality.
6. 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 study.
7. Already participating in, or planning to start other psychological treatments (including CBT) within the duration of the study (12 months).
8. Anticipated problems with the patient attending CBT sessions and/or returning for follow-up.
9. Incarceration.
10. Other reason to exclude the patient, as specified.

Primary outcomes:
measure: The prevalence of Persistent Post-Surgical Pain at 12 months' post-fracture
timeFrame: 12 months post-fracture
Secondary outcomes:
measure: Short Form 12 (SF-12)
timeFrame: 1 year
measure: Return to Function questionnaire
timeFrame: 1 year
measure: PROMIS-Physical Function 28
timeFrame: 1 year
Other outcomes:
measure: Exploratory outcome 1: Fracture healing complications
timeFrame: 1 year
measure: Exploratory outcome 2: time to fracture healing
timeFrame: 1 year
measure: Exploratory outcome 3: opioid use
timeFrame: 1 year
Locations:
city: Hamilton
country: Canada
facility: St. Joseph Hospital
state: Ontario
Study officials:
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