Observational Study of the Nociceptive Flexion Reflex Threshold to Predict Outcome After Interventional Pain Management Procedures in Patients With Chronic Back and Neck Pain. A Study of Diagnostic Accuracy
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- ROC-AUC for incidence of pain reduction>30% at 1 week
研究概览
简要总结
Interventional pain management for back and neck pain is widely used, but the indications and relative merits of these techniques rest subject to discussion. This study aims to identify prognostic criteria for patients who might specifically benefit from interventional pain management. Specifically, the nociceptive reflex threshold will be investigated, which is a measure of central sensibilisation and thus a potentially important prognostic factor.
详细描述
Interventional pain management is resource-intensive and carries non-negligible risks. Not all patients profit equally from such procedures. For those who do not benefit, the risk of potential complications is futile, and the resources are wasted. Therefore, a possibility to distinguish responding patients from non-responders would be important.
Central pain sensitization has been related to poor outcome, and electrical pain and reflex thresholds are a good measure of pain hypersensitivity at least in chronic low back pain. Especially the nociceptive flexion reflex (NFR) threshold has been identified to correlate well with central pain hypersensibility. Successful interventional pain treatment has been shown to reverse central hypersensibility as measured by the NFR threshold.
NFR threshold, in contrast to pain threshold, seems to be a measure independent of psychological factors. Thus the NFR threshold could give information independent of psychological factors in order to predict poor outcome of interventional pain management procedures.
The study will be a prospective observational trial of diagnostic accuracy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •patients with chronic low back or neck pain (duration >3 months)
- •scheduled for the following interventions: epidural injection, facet block, medial branch block, facet radiofrequency denervation, spinal cord stimulator implantation
排除标准
- •inability to understand the patient information or the study questionnaires
- •patients <18 years old
- •patients with implanted pacemakers or defibrillators
结局指标
主要结局
ROC-AUC for incidence of pain reduction>30% at 1 week
时间窗: 1 week
Primary study outcome is the diagnostic accuracy of the NFR threshold, measured as area under the "receiver operating characteristic ROC" curve, for the following main pain management outcome: "pain reduction of 30% one week after the interventional procedure
次要结局
- ROC-AUC for patient rating of improvement and satisfaction at 1 week(1 week)
- ROC-AUC for incidence of pain reduction>30% at 1 month(1 month)
- ROC-AUC for emotional functioning at 1 week(1 week)
- ROC-AUC for incidence of pain reduction>30% at 6 months(6 months)
- adverse events of interventional pain management(1 week)
- patient disposition at 1 week, 1,3, and 6 months(6 months)
- ROC-AUC for incidence of pain reduction>30% at 3 months(3 months)
- ROC-AUC for physical functioning at 1 week(1 week)
研究者
Benno Rehberg-Klug
Médecin adjoint agrégé
University Hospital, Geneva