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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- COMI (Core Outcome Measure Index)
研究概览
简要总结
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.
详细描述
The incidence of moderate to severe chronic postsurgical pain (CPSP) at 12 months after surgery is circa 12% in Europe, depending in part upon the surgical procedure. Worldwide, more than 230 million people undergo major surgery every year; the global annual cost of new cases of CPSP is in the hundreds of billions of dollars. The response to this costly tragedy has been unacceptably slow.
Perioperative protocols have historically not incorporated routine screening for patients at-risk for post-surgery persistent pain or compromised function. However, early detection and management of patients at high risk for CPSP may modify the postsurgical pain trajectory and reduce the incidence of CPSP.
In particular, persistent pain and disability after spinal surgery poses a large problem. Around 20% of the patients have persistent or recurrent pain in the back or limbs after surgical interventions for spinal disease. Several risk factors for such unfavorable outcomes have been identified, among which psychological factors. The most robust psychological predictors of high levels of acute postsurgical pain and of persistent pain in the back or limbs after spinal surgery are high levels of preoperative anxiety and pain catastrophizing.
Psychological variables are modifiable and could be target for intervention. Cognitive Behavioral Therapy (CBT) is the leading psychological treatment for chronic pain. CBT aims to reduce maladaptive cognitions and behaviors and replace these with more adaptive ones. CBT has been shown to reduce anxiety and catastrophizing and to increase self-efficacy and feelings of control beliefs and through this lowers pain-related disability and pain interference (including sleep problems and depression).
This study is a prospective, randomized, controlled multicenter trial with 1:1 allocation, comparing lumbar spinal fusion surgery outcome between 2 groups with high pain catastrophizing, 1 that receives perioperative CBT plus usual care (experimental group) and 1 that receives usual care (control group). To minimize expectation bias in patients, an educational intervention is added in the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The investigators and research assistants assessing outcomes will be blinded to group assignment. The psychologist/s delivering the CBT and the clinicians delivering the educational intervention in the control group cannot be blinded. Nevertheless, patients will be blinded to study hypotheses and will be informed that the study is examining the comparative benefits of two treatments that are given in addition to usual care and that may potentially improve outcomes. The patients will not be aware of the study hypotheses and will not be informed about the likely association between a high PCS score and lower outcomes after lumbar spinal surgery, neither about the fact that the control intervention (i.e. an educational & exercise intervention that is expected to minimize/cancel any expectation bias) will not address catastrophizing.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
COMI (Core Outcome Measure Index)
时间窗: 12 months post surgery
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.
次要结局
- NRS Pain (The Numeric Rating Scale for Pain)(4 days, 8 weeks, 6 and 12 months post surgery)
- ODI (Oswestry Disability Index)(8 weeks, 6 and 12 months post surgery)
- PROMIS (Patient-Reported Outcomes Measurement Information System) for depression(8 weeks, 6 and 12 months post surgery)
- PGIC (Patient's global impression of change)(8 weeks, 6 and 12 months post surgery)
- PCS (Pain catastrophizing)(8 weeks, 6 and 12 months post surgery)
- EQ-5D-5L (The 5-level EuroQol 5 Dimensions) for quality of life(8 weeks, 6 and 12 months post surgery)
研究者
Pietro Scarone
Staff Neurosurgeon, Principal Investigator
Neurocenter of Southern Switzerland