A randomized controlled TRIal of cognitive BEhavioral therapy for high Catastrophizing in patients undergoing lumbar fusion surgery: the TRIBECA study

P Scarone,M Peters,E Koetsier,S M J Van Kuijk,H Van Santbrink,A Y J M Smeets

doi:10.1186/s12891-020-03826-w

Abstract

BackgroundAround 20% of patients undergoing spinal fusion surgery have persistent back or leg pain despite surgery. Pain catastrophizing is the strongest psychological predictor for chronic postsurgical pain. Psychological variables are modifiable and could be target for intervention. However, randomized controlled trials evaluating the effectiveness of psychological interventions to reduce chronic pain and disability after spinal fusion in a population of patients with high preoperative pain catastrophizing scores are missing. The aim of our study is to examine whether an intervention targeting pain catastrophizing mitigates the risk of chronic postsurgical pain and disability. Our primary hypothesis is that targeted perioperative cognitive behavioral therapy decreases the risk of chronic postsurgical pain and disability after spinal fusion surgery in high catastrophizing patients.MethodsWe will perform a two-center prospective, single-blind, randomized, controlled study comparing lumbar spinal fusion surgery outcome between 2 cohorts. Adult patients selected for lumbar spinal fusion with decompression surgery and a minimum score of 24 on the pain catastrophizing scale will be randomized with 1:1 allocation for either perioperative cognitive behavioral therapy (intervention group) or a perioperative education plus progressive exercise program (control group). Patients randomized to the intervention group will receive six individual sessions of cognitive behavioral therapy, two sessions before the operation and four after. Primary outcome is the Core Outcome Measures Index at 12 months. Secondary outcomes include pain, disability, depression and quality of life.DiscussionThis is the first trial that evaluates the effectiveness of cognitive behavioral therapy as a perioperative tool to improve pain and disability after spinal fusion surgery in comparison with an educational/exercise control intervention, in patients with high levels of pain catastrophizing. If perioperative cognitive behavioral therapy proves to be effective, this might have important clinical implications, reducing the incidence of chronic postsurgical pain and improving outcome after spinal fusion surgery.Trial registrationClinicaltrials (NCT03969602). Registered 31 May 2019,

Highlights

Around 20% of patients undergoing spinal fusion surgery have persistent back or leg pain despite surgery
The aim of our study is to examine whether a perioperative intervention that targets pain catastrophizing can mitigate the risk of chronic postsurgical pain (CPSP), i.e. improve the outcome of the surgical intervention, in patients that report high levels of pain catastrophizing and for whom lumbar spinal fusion surgery is indicated
While a clear benefit in terms of pain, disability and return to work has been shown in patients suffering from spinal instability [46,47,48], recent randomized controlled trials (RCT)’s [47, 49] have questioned the usefulness of spinal fusion procedures for other conditions like spinal stenosis or degenerative spondylolisthesis

Summary

Introduction

Around 20% of patients undergoing spinal fusion surgery have persistent back or leg pain despite surgery. Our primary hypothesis is that targeted perioperative cognitive behavioral therapy decreases the risk of chronic postsurgical pain and disability after spinal fusion surgery in high catastrophizing patients. Several predictive factors for CPSP have been identified, the most important being chronic preoperative pain, high intensity of acute postoperative pain and several psychological factors [4]. Of these psychological factors, pain catastrophizing has emerged as a robust predictor of pain severity and work disability among individuals with persistent musculoskeletal pain and is the strongest predictor for CPSP [5,6,7]. It is even postulated that catastrophizing could have a direct influence on the neurophysiologic mechanisms involved in pain processing [8]

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