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

Summary

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.

Conditions

• Lumbar Spinal Stenosis
• Lumbar Spondylolisthesis
• Lumbar Instability
• Spinal Disease

Interventions

BEHAVIORAL

Cognitive-behavioral Therapy

The biopsychosocial approach of CBT focuses on the complex interaction between psychological, social and biological factors. The biopsychosocial model assumes that health problems are hardly ever limited to just one domain of human experience but by multiple domains of human experience. CBT helps patients understand thoughts and feelings that influence behaviors. It consists of a cognitive aspect and a behavioral aspect. The cognitive aspect is based on Becks cognitive model: the way that individuals perceive a situation is more closely connected to their reaction than the situation itself. A person's cognition has impact on their mood and emotions, their bodily reactions and their behavior. The second part of cognitive behavior therapy focuses on the actual behaviors that are contributing to the problem. The goal of CBT is to identify maladaptive thoughts and change them into more realistic and constructive thoughts to modify feelings and behavior and thereby the experience of pain.

OTHER

Biomedical and surgery-specific education

Biomedical and surgery-specific education preoperatively and an exercise manual postoperatively.

Sponsors & Collaborators

• Maastricht University

  collaborator OTHER

• Schulthess Klinik

  collaborator OTHER

• Neurocenter of Southern Switzerland

  lead OTHER

Principal Investigators

• Pietro Scarone, M.D. · Neurocenter of Southern Switzerland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-23

Primary Completion

2023-07-30

Completion

2023-07-30

Countries

• Switzerland

Study Locations