Cognitive Behavioral Therapy (CBT) After Lumbar Spinal Fusion in Patients With High Pain Catastrophizing (TRIBECA)
Lumbar Spinal Stenosis, Lumbar Spondylolisthesis, Lumbar Instability
About this trial
This is an interventional treatment trial for Lumbar Spinal Stenosis focused on measuring Pain Catastrophizing, Cognitive Behavioral Therapy, Rehabilitation, Spinal disease, Spinal fusion
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
Sites / Locations
- Neurocenter of Southern Switzerland, Neurosurgical ServiceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
No Intervention
Experimental Group
Control Group
Observational Group (low catastrophizing)
Participants randomized will receive six individual 1-hour sessions of CBT: two sessions before the operation and four after, delivered by a psychologist trained in CBT for chronic pain. The CBT intervention is tailored to reduce pain catastrophizing. Main techniques are: pain education and the influence of cognitions, emotions and behavior on pain and pain disability; identification of catastrophizing cognitions and replacing them with more adaptive cognitions; stress/anxiety reduction by diaphragmatic breathing and progressive muscle relaxation; emotion regulation skills training; cognitive restructuring; coping skills training to combat helplessness and foster a sense of control and self-efficacy for dealing with acute post-operative pain. The four postoperative sessions build on and further extend the skills learned preoperatively. Each session ends with specific homework assignments. All patients receive a homework book and an individually tailored instruction manual.
Participants will have six meetings with members of the research team (in person or through telephone). In a first preoperative meeting a member of the team provides verbal information on the preparation for surgery, surgery itself and recovery from surgery, stressing the importance of postoperative exercise. Any questions raised by the patient are discussed. A booklet is provided with information about: structure of the spinal column and spinal diseases; examinations before surgery; the operative environment; surgical procedures; anesthetic procedures; postoperative care and postoperative pain reduction. A second preoperative (telephone) meeting is scheduled to answer any remaining questions. During the postoperative phase, instructions and an exercise manual are provided, Patients keep a diary to record their training activity. Three, six and eight months after discharge patients are contacted by telephone and their training progress is discussed.
Patients will be routinely prescribed medications for pain control and are referred for physical therapy on an out-patient basis in different sites or an in-patient basis in specialized rehabilitation centers following lumbar spinal fusion surgery, depending on the needs. Typically, a full rehabilitation regime starts 2-3 weeks after surgery. Usual programs involve active spinal mobilization aimed at gradually improving the range of motion, exercises to strengthen spinal deep muscles, and segmentary stretching involving the lower limb and back muscles, together with manual therapy. The patients are also given walking exercises and trained in how to change position.