Lumbar Spinal Stenosis Clinical Trial
— TRIBECAOfficial title:
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 Plus Usual Care
Catastrophizing has emerged as the strongest independent predictor for persistent
postsurgical pain. Although behavioral interventions, including Cognitive Behavioral Therapy
(CBT), have been shown to reduce the impact of persistent pain, postsurgical patients have
not historically been offered these interventions. The aim of our study is to examine whether
an intervention targeting pain catastrophizing can reduce the risk of persistent pain and
disability after spinal fusion.
Our primary hypothesis is that a perioperative cognitive behavioral intervention with the
goal to decrease anxiety and pain catastrophizing will decrease the risk of persistent pain
and disability after spinal fusion surgery in high catastrophizing patients.
To study this hypothesis the investigators will perform a prospective, randomized, controlled
multicenter trial with 1:1 allocation, comparing 2 cohorts.
Patients aged > 18 years/old, with a primary diagnosis of spinal stenosis, degenerative or
isthmic spondylolisthesis or degenerative disc disease (DDD) determined by expert spine
surgeons and selected for lumbar spinal fusion surgery with decompression will be screened
for high levels of pain catastrophizing using the Pain Catastrophizing Scale (PCS). Patients
with a score of ≥ 24 on the PCS who will consent to the study will be randomized to CBT (2
sessions preoperatively and 4 sessions postoperatively) plus usual care (experimental group)
or usual care (control group). To limit expectation bias, an educational intervention will be
added in the control group.
Primary outcome is the Core Outcome Measure Index (COMI) at 12 months. Secondary outcomes are
scores on 11-point Numeric Rating Scale (NRS) for back and leg pain, Oswestry Disability
Index (ODI), Patient-reported outcomes measurement - depression (PROMIS-D), Patient Global
Impression of Change (PGIC), Pain Catastrophizing (PCS), reliance on analgesics and
employment status. NRS will be measured on the 4th postoperative day, at 8 weeks, 6 months
and 1 year, while all other outcomes will be measured at 8 weeks, 6 months and 1 year.
Status | Recruiting |
Enrollment | 126 |
Est. completion date | July 30, 2023 |
Est. primary completion date | July 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Neurocenter of Southern Switzerland, Neurosurgical Service | Lugano |
Lead Sponsor | Collaborator |
---|---|
Neurocenter of Southern Switzerland | Maastricht University, Schulthess Klinik |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | COMI (Core Outcome Measure Index) | The COMI comprises a short set of questions used to assess the impact of spinal disorders on multiple patient-orientated outcome domains. It is based on a set of individual items selected from established questionnaires and recommended for standardized use by an international group of experts in the field. It consists of seven items to assess the extent of the patient's back pain and leg pain, difficulties with functioning in everyday life, symptom-specific well-being, general quality of life, and social and work disability. A summary index score from 0 (best health status) to 10 (worst health status) can be computed by averaging the values of the five subscales. | 12 months post surgery | |
Secondary | NRS Pain (The Numeric Rating Scale for Pain) | NRS-11 is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. Rating = 0 indicates no pain, rating =1-3 indicates mild pain, rating 4-6 indicates moderate pain while rating 7-10 indicates severe pain. | 4 days, 8 weeks, 6 and 12 months post surgery | |
Secondary | ODI (Oswestry Disability Index) | The ODI questionnaire is a self-administered set of ten questions assessing the patient's level of pain and function during activities of daily living such as walking, personal care, standing, sleeping, etc. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score as follows: 0%-20%=Minimal disability, 20%-40% = Moderate disability, 40%-60% = Severe disability, 60%-80%= Crippled, 80%-100% = bed bound. | 8 weeks, 6 and 12 months post surgery | |
Secondary | PROMIS (Patient-Reported Outcomes Measurement Information System) for depression | The PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. For the present study, the PROMIS Short Form v1.0 - Depression 8b will be used. This questionnaire, part of the PROMIS depression toolbox, has 8 items that are scored on a 1- 5 scale. For each question, a score of 1 indicates "never" (better score) while a score of 5 indicates "always" (worse score). A total score is obtained by summing the values of the responses to each question, ranging from 8 (low level of depression) to 40 (high level of depression). | 8 weeks, 6 and 12 months post surgery | |
Secondary | PGIC (Patient's global impression of change) | Patients rate their perceived improvement on a 7-point Likert Scale from 1 (very much improved) to 7 (very much worse). | 8 weeks, 6 and 12 months post surgery | |
Secondary | PCS (Pain catastrophizing) | The Pain Catastrophizing Scale (PCS) has 13 items that are scored on a 5-point scale ranging from 0 (never) to 4 (always), providing a total score that can range from 0 to 52. | 8 weeks, 6 and 12 months post surgery | |
Secondary | EQ-5D-5L (The 5-level EuroQol 5 Dimensions) for quality of life | The EQ-5D-5L questionnaire uses a health state classification defining health in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems and 5= extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state, ranging from 11111 (no problems in any of the 5 dimensions) to 55555 (extreme problems in all dimensions). The health states are then converted into a single index value from 0 (worse) to 1 (best). | 8 weeks, 6 and 12 months post surgery |
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