NCT03969602: TRIBECA

Cognitive Behavioral Therapy (CBT) After Lumbar Spinal Fusion in Patients With High Pain Catastrophizing

Status unknown NA Last updated 6 October 2020

What this trial tests

NA trial testing Cognitive-behavioral Therapy in Lumbar Spinal Stenosis in 126 participants. Status unknown.

Timeline

23 January 2020

Primary endpoint
30 July 2023

30 July 2023

Quick facts

Lead sponsor	Neurocenter of Southern Switzerland
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	126
Start date	23 January 2020
Primary completion	30 July 2023
Estimated completion	30 July 2023
Sites	1 location across Switzerland

Drugs / interventions tested

• Cognitive-behavioral Therapy
• Biomedical and surgery-specific education

Conditions studied

• Lumbar Spinal Stenosis — all drugs for Lumbar Spinal Stenosis →
• Lumbar Spondylolisthesis — all drugs for Lumbar Spondylolisthesis →
• Lumbar Instability — all drugs for Lumbar Instability →
• Spinal Disease — all drugs for Spinal Disease →

Sponsor

Neurocenter of Southern Switzerland

Who can join

18 and older, any sex, with Lumbar Spinal Stenosis or Lumbar Spondylolisthesis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Catastrophizing has emerged as the strongest independent predictor for persistent postsurgical pain. Although behavioral interventions, including Cognitive Behavioral Therapy (CBT), have been shown to reduce the impact of persistent pain, postsurgical patients have not historically been offered these interventions. The aim of our study is to examine whether an intervention targeting pain catastrophizing can reduce the risk of persistent pain and disability after spinal fusion.

Our primary hypothesis is that a perioperative cognitive behavioral intervention with the goal to decrease anxiety and pain catastrophizing will decrease the risk of persistent pain and disability after spinal fusion surgery in high catastrophizing patients.

To study this hypothesis the investigators will perform a prospective, randomized, controlled multicenter trial with 1:1 allocation, comparing 2 cohorts.

Patients aged \> 18 years/old, with a primary diagnosis of spinal stenosis, degenerative or isthmic spondylolisthesis or degenerative disc disease (DDD) determined by expert spine surgeons and selected for lumbar spinal fusion surgery with decompression will be screened for high levels of pain catastrophizing using the Pain Catastrophizing Scale (PCS). Patients with a score of ≥ 24 on the PCS who will consent to the study will be randomized to CBT (2 sessions preoperatively and 4 sessions postoperatively) plus usual care (experimental group) or usual care (control group). To limit expectation bias, an educational intervention will be added in the control group.

Primary outcome is the Core Outcome Measure Index (COMI) at 12 months. Secondary outcomes are scores on 11-point Numeric Rating Scale (NRS) for back and leg pain, Oswestry Disability Index (ODI), Patient-reported outcomes measurement - depression (PROMIS-D), Patient Global Impression of Change (PGIC), Pain Catastrophizing (PCS), reliance on analgesics and employment status. NRS will be measured on the 4th postoperative day, at 8 weeks, 6 months and 1 year, while all other outcomes will be measured at 8 weeks, 6 months and 1 year.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A randomized controlled TRIal of cognitive BEhavioral therapy for high Catastrophizing in patients undergoing lumbar fusion surgery: the TRIBECA study.
   Scarone P, Smeets AYJM, van Kuijk SMJ, van Santbrink H, et al · · 2020 · cited 11× · PMID 33276768 · DOI 10.1186/s12891-020-03826-w