Evaluation of an Online Tool (E-TOOL) in the Selection of Patients for Spinal Cord Stimulation for Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Numerical rating scale
研究概览
简要总结
This observational multicenter study aims to evaluate the reliability and validity of the e-tool for selecting patients eligible for SCS for chronic pain caused by one of the four etiologies listed above in the experience of daily clinical practice. The implantation procedure and devices used will be those used in the routine clinical practice of participating centers. Since the study is observational, the use of the e-tool will not replace the routine medical and psychological evaluation in participating centers before SCS implantation.
Study Objectives:
Primary Objective: Evaluate the degree of agreement/disagreement between the physicians opinion and the e-tool in selecting patients eligible for spinal cord stimulation for chronic pain. Endpoint: Calculation of the probability of disagreement (πD) between the e-tool and the physicians opinion regarding the appropriateness of the intervention.
Secondary Objective: Evaluate the ability of the e-tool to classify interventions defined as appropriate and highly likely to succeed; (scores 7-9) at 3 different time points: trial, 6-month follow-up, and 12-month follow-up. The proportion of interventions that were successful at the trial implantation in different time points will be compared with the proportion of interventions identified as appropriate and highly likely to succeed by the e-tool.
Study Period: 24 months. 12 months of enrollment + 12 months of follow-up. Subjects: Number of subjects to be included: at least 60 (total divided between the two centers)
Participating Centers:
- Pain Therapy Unit - ICSMaugeri, Pavia
- Anesthesia and Pain Therapy SD - Azienda Ospedaliero Universitaria Pisana Pisa
详细描述
Spinal Cord Stimulation (SCS) has been a therapy in the treatment of chronic pain for 50 years, particularly for patients resistant to conventional pharmacological treatment and other less complex invasive procedures. Over the years, various versions of guidelines have been established and drafted for the selection and clinical indications in which SCS therapy is most likely to be successful. The main clinical indications include:
- Chronic pain in the lumbar region and lower limbs, especially in patients who have undergone spine surgeries (Failed Back Surgery Syndrome, FBSS).
- Complex Regional Pain Syndrome (CRPS).
- Peripheral neuropathic pain.
- Ischemic pain in the limbs. In daily clinical practice, the heterogeneity of patients often makes it difficult to determine which patients are eligible for this treatment. A large number of clinical studies suggest that cognitive aspects and individual coping mechanisms in dealing with pain experiences impact treatment response. For this reason, international guidelines recommend that individuals considered for SCS should undergo a comprehensive psychological evaluation.
Recently, an online tool (SCS-e-tool) has been implemented for selecting patients eligible for SCS implantation. Developed by a team of experts in pain therapy with various clinical backgrounds, this tool is freely available online and can be used by healthcare professionals. It is designed to assist in evaluating a patients suitability for spinal cord stimulation and aid in making informed clinical decisions.
The SCS-e-tool takes into account various factors, including cognitive aspects and the patient pain management modalities. The goal is to provide a comprehensive and personalized assessment to identify patients who may benefit most from spinal cord stimulation therapy. This tool can be a valuable aid for healthcare professionals in the decision-making process regarding patient selection for SCS therapy.
It is important to note that, despite the utility of assessment tools, the final decision on a patient candidacy for spinal cord stimulation should be based on a comprehensive evaluation that includes clinical, psychological, and individual aspects of the patient.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Males and females aged between 18 and 85 years.
- •Patients with chronic pain and indication for implantation of a temporary neurostimulator for spinal cord stimulation testing.
- •Signed informed consent.
排除标准
- •• Patients who, in the researcher's judgment, are unable to follow the protocol instructions.
- •Patients in presumed/confirmed pregnancy.
- •Contraindications to implantation.
结局指标
主要结局
Numerical rating scale
时间窗: through study completion, an average of 1 year
Numeric Rating Scale (NRS): a scale for pain intensity assessment useful for controlling therapies, clinical routine monitoring, and scientific studies. The result is the indication of pain intensity on a scale from 0 to 10, where 0 indicates no pain, and 10 indicates the maximum imaginable pain
次要结局
- Oswestry Disability Index(through study completion, an average of 1 year)
- European Quality of life, EuroQol(through study completion, an average of 1 year)
- Evaluate the ability of the E-TOOL to classify interventions defined as appropriate and highly likely to succeed(perioperatively/periprocedurally)
- Patient global impression of change (PGIC)(through study completion, an average of 1 year")