Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT03969602
Eligibility Criteria:
Inclusion Criteria:
* able to read and speak Italian (site 1) or Dutch (site 2)
* a primary diagnosis of spinal stenosis, 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 PCS to be randomized to perioperative CBT plus usual care or education plus usual care, required to complete all questionnaires (see study schedule)
* patients with a score of \< 24 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
* 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 intrathecal pump
* prisoners
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03969602
Study Brief:
Protocol Section:
NCT03969602