Spinal Cord Stimulation for Refractory Pain in Erythromelalgia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6
- 试验地点
- 7
- 主要终点
- Changes in pain
研究概览
简要总结
Erythromelalgia is a rare disorder characterized by red, warm, and painful extremities, which is often precipitated by warm conditions. The pathophysiology is incompletely understood. The management of pain in erythromelalgia is challenging as no single therapy has been found to be effective. Response to pharmacotherapy varies, meaning that the physician has to take a stepwise trial and error approach with each patient. Consequently, this disorder is often associated with poorer health-related quality of life. There is currently no consensus or guideline on management of pain in erythromelalgia. Spinal cord stimulation is a widely applied therapy to treat severe chronic pain of various origin. Case reports and anecdotal evidence suggest that this therapy might alleviate refractory pain in patients with erythromelalgia.
The aim of this trial is to evaluate the efficacy of spinal cord stimulation for refractory pain in erythromelalgia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
1st blinding: patients will be blinded to the actual treatment allocation during the different study periods (first blinding). 2nd: surgeons and all study personnel involved in handling the patients and collecting the study data (except those who perform the actual setting of the device) will be blinded to the actual treatment allocation. 3rd: All study personnel evaluating end point measures will be blinded to the actual treatment. 4th All the tables and figures to be presented from the study will be settled before any data from the study is evaluated in order to avoid selective presentation of findings according to statistical results. 5th The statistician performing the statistical procedures on the outcome of the study will be blinded. The data will only show treatment allocation as treatment A and treatment B. Then the tables and figures are filled in.
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
- •A diagnosis of primary or idiopathic erythromelalgia
- •Patients ≥18 years who have developed chronic pain that has remained refractory to medical treatment for ≥6 months.
- •Minimum pain intensity of 5/10 on a numeric rating scale NRS at baseline.
- •Successful two-week SCS testing period with tonic stimulation (≥2 points reduction in pain NRS from baseline). This means patients will experience paresthesia during the trial period of spinal cord stimulation.
排除标准
- •Coexisting conditions that would increase procedural risk (e.g., sepsis, coagulopathy).
- •History of laminectomy or posterior fusion at the thoracolumbar junction, where percutaneous electrode end tips are routinely placed.
- •Abnormal pain behavior and/or unresolved psychiatric illness.
- •Unresolved issues of secondary gain or inappropriate medication use.
- •Unfit for participation for any other reason as judged by the study physician.
研究组 & 干预措施
Burst spinal cord stimulation (SCS)
following implantation of a generator that sends pulses to a thin wire (lead), which delivers pulses to nerves along the spinal cord, the patients will initially undergo four six-week long periods with either burst SCS or no stimulation (sham) in a randomized order. During this period all patients will undergo two periods of SCS and sham stimulation.
干预措施: Burst Spinal Cord Stimulation (Procedure)
Burst spinal cord stimulation (SCS)
following implantation of a generator that sends pulses to a thin wire (lead), which delivers pulses to nerves along the spinal cord, the patients will initially undergo four six-week long periods with either burst SCS or no stimulation (sham) in a randomized order. During this period all patients will undergo two periods of SCS and sham stimulation.
干预措施: Sham spinal cord stimulation (Procedure)
sham spinal cord stimulation (SCS)
following implantation of a generator that sends pulses to a thin wire (lead), which delivers pulses to nerves along the spinal cord, the patients will initially undergo four six-week long periods with either burst SCS or no stimulation (sham) in a randomized order. During this period all patients will undergo two periods of SCS and sham stimulation.
干预措施: Burst Spinal Cord Stimulation (Procedure)
sham spinal cord stimulation (SCS)
following implantation of a generator that sends pulses to a thin wire (lead), which delivers pulses to nerves along the spinal cord, the patients will initially undergo four six-week long periods with either burst SCS or no stimulation (sham) in a randomized order. During this period all patients will undergo two periods of SCS and sham stimulation.
干预措施: Sham spinal cord stimulation (Procedure)
结局指标
主要结局
Changes in pain
时间窗: 6 months
assessed with a 0 -to-10 numerical rating scale (NRS)
次要结局
- Daily physical activity(6 months)
- Severity of erythema(6 months)
- Health Care Provider's Costs(6 months)
- Change in generic health-related quality of life(6 months)
- Oswestry disability index (ODI) score(6 months)