Pain, Postoperative Clinical Trial
Official title:
Cognitive Behavioural Therapy to Improve Outcomes of High Risk Patients Following Internal Fixation of Extremity Fractures: A Randomized Controlled Trial (SPOC-CBT)
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.
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.
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