The Impact of Cognitive Behavioral Therapy (CBT) on Treatment Outcome after Lumbar Spinal Fusion Surgery in Patients with High Pain Catastrophizing: a Two-center Randomized Controlled Trial of CBT vs. Educatio

Recruiting

Conditions: pijn catastrofatie
spinal fusion surgery and catasthrophyzing
surgical technique that joins two or more vertebrae and strong negative thoughts about pain
10009720

Registration Number: NL-OMON49688

Lead Sponsor: EOC Lugano

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 75

Inclusion Criteria

- age >= 18 years
- able to read and speak Italian (site 1) or Dutch (site 2)
- a primary diagnosis of spinal stenosis (central or foraminal, or both),
degenerative or isthmic spondylolisthesis or degenerative disc disease (DDD)
determined by expert spine surgeons
- selected for lumbar spinal fusion surgery with decompression
- patients with a score of >= 24 on the pain catastrophizing scale (PCS) will be
eligible to be randomized to perioperative cognitive behaviour therapy (CBT) or
education.
- patients with a score of < 24 PCS will not be randomized to one of the
treatment groups but are eligible for preoperative and postoperative assessment.
- are able to provide informed consent and have signed the informed subject
consent form

Exclusion Criteria

- report plans to undergo major surgery within six months after current lumbar
spinal fusion surgery
- comorbid severe psychiatric conditions such as schizophrenia or personality
disorder
- known or suspected non-compliance, drug or alcohol abuse
- inability to follow the procedures of the study, e.g. due to dementia, etc.
of the participant
- the presence of any serious medical comorbidity such as sepsis or cancer that
might cause disability or worsen the patient*s general health condition
- pregnancy is an *automatic* exclusion because women who are pregnant are
excluded by their physicians from lumbar spinal fusion surgery
- an opioid intrathechal pump
- prisoners

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome:<br /><br>- Core Outcome Measures Index (COMI) at 12 months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes at 4 days postoperative<br /><br>- 11-point Numeric Rating Scale (NRS) (out of COMI) for back and leg on the 4th<br /><br>post-operative day, ranging from 0 (no pain at all) to 10 (worst pain ever).<br /><br><br /><br>Secondary outcomes at 8 weeks and 6 and 12 months:<br /><br>- Core Outcome Measures Index (COMI) is also assessed at 8 weeks and 6 months<br /><br>- 11-point NRS for back and leg, ranging from 0 (no pain at all) to 10 (worst<br /><br>pain ever) (included in COMI)<br /><br>- Disability: Modified Oswestry Disability Index (ODI)<br /><br>- Health related quality of life: EuroQualityOfLife-5 dimensions* (EQ-5D)<br /><br>questionnaire<br /><br>- Depression: PROMIS, (Patient-Reported Outcomes Measurement Information<br /><br>Sys-tem) v1.0)<br /><br>- Patient Global Impression of Change (PGIC)<br /><br>- Pain Catastrophizing Scale (PCS)<br /><br>- Medication Quantification Scale (MQS)<br /><br>- Employment status</p><br>