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Clinical Trials/NL-OMON49688
NL-OMON49688
Recruiting
Not Applicable

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. Education - TRIBECA FUSIO

EOC Lugano0 sites75 target enrollmentTBD
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Conditionspijn catastrofatiespinal fusion surgery and catasthrophyzingsurgical technique that joins two or more vertebrae and strong negative thoughts about pain10009720

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
pijn catastrofatie
Sponsor
EOC Lugano
Enrollment
75
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
EOC Lugano

Eligibility 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
  • •\- 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.

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
  • •\- 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

Outcomes

Primary Outcomes

Not specified

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