pijn catastrofatie spinal fusion surgery and catasthrophyzing
Conditions
Interventions
Cognitive Behavious Therapy (CBT): Participants randomized to the experimental
group will receive six individual 1-hour sessions of CBT (except the first
session which will take 1.5 hour). Two sessi
Sponsors
EOC Lugano
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: - Core Outcome Measures Index (COMI) at 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes at 4 days postoperative - 11-point Numeric Rating Scale (NRS) (out of COMI) for back and leg on the 4th post-operative day, ranging from 0 (no pain at all) to 10 (worst pain ever). Secondary outcomes at 8 weeks and 6 and 12 months: - Core Outcome Measures Index (COMI) is also assessed at 8 weeks and 6 months - 11-point NRS for back and leg, ranging from 0 (no pain at all) to 10 (worst pain ever) (included in COMI) - Disability: Modified Oswestry Disability Index (ODI) - Health related quality of life: EuroQualityOfLife-5 dimensions* (EQ-5D) questionnaire - Depression: PROMIS, (Patient-Reported Outcomes Measurement Information Sys-tem) v1.0) - Patient Global Impression of Change (PGIC) - Pain Catastrophizing Scale (PCS) - Medication Quantification Scale (MQS) - Employment status | — |
Countries
Netherlands
Outcome results
None listed