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

• Published in: BMC musculoskeletal disorders Vol. 21; no. 1; p. 810
• Main Authors: Scarone, P, Smeets, A Y J M, van Kuijk, S M J, van Santbrink, H, Peters, M, Koetsier, E
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 04.12.2020; BioMed Central; BMC
• Subjects: Adult; Back surgery; Behavior modification; Care and treatment; Catastrophization; Chronic pain; Chronic postsurgical pain (CPSP); Clinical trials; Cognitive ability; Cognitive Behavioral Therapy; Cognitive behavioral therapy (CBT); Cognitive therapy; Comorbidity; Complications and side effects; Decompression; Education; Ethics; Humans; Intervention; Lumbar spinal fusion surgery; Lumbar Vertebrae - surgery; Musculoskeletal diseases; Neurosurgery; Pain; Pain catastrophizing; Pain, Postoperative; Patients; Pedicle screws; Prospective Studies; Psychological aspects; Quality of Life; Single-Blind Method; Spinal fusion; Spinal Fusion - adverse effects; Study Protocol; Surgery; Testing; Treatment Outcome; Netherlands; Switzerland; Lumbar spinal fusion surgery; Pain catastrophizing; Education; Chronic postsurgical pain (CPSP); Pedicle screws; Cognitive behavioral therapy (CBT)
• ISSN: 1471-2474; 1471-2474
• DOI: 10.1186/s12891-020-03826-w

Around 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. We 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. This 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. Clinicaltrials ( NCT03969602 ). Registered 31 May 2019.