Sciatic Block in Contralateral Limb for Treatment of Refractory Phantom and Residual Limb Pain; a Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Functional Improvement
研究概览
简要总结
This research is being done to determine if an anesthetic like Lidocaine, may be effective when injected around the sciatic nerve of the intact limb in patients with limb loss pain on the contralateral side.
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, Investigator)
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
- •Lower extremity amputation performed more than 12 months before study enrollment
- •PLP/RLP in affected amputated limb > 4 on NRS26
- •Pain duration of more than 6 months despite a trial of conservative therapies for at least 2 months, including oral medications, topical medicines, physical therapy, and physical modalities (i.e., heat, cold, transcutaneous electrical nerve stimulation, phonophoresis)
- •Willingness to undergo image guided diagnostic nerve block
排除标准
- •Refusal / inability to participate or provide consent
- •Contraindications to diagnostic nerve block
- •Non-neurogenic source of PLP/RLP
- •Current opioid use > 50 morphine milligram equivalents per day
- •Any interventional pain treatment in the residual limb within the last 30 days
- •Severe uncontrolled medical condition (i.e., hypertensive crisis, decompensated hypothyroidism)
- •Use of investigational pain drug within past 30 days or other concurrent clinical trial enrollment
研究组 & 干预措施
Lidocaine Group
Subjects will receive a lidocaine injection in the back of their residual limb.
干预措施: Lidocaine (Drug)
Sham Group
Subjects will receive a placebo injection in the back of their residual limb.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Functional Improvement
时间窗: Baseline, 5 days post-injection
Measured using self-reported 20-item Orthotic and Prosthetics User's Survey (OPUS) Lower Extremity Functional Status Measurement survey. Total scores range from 0-100 scale with higher scores indicating a better outcome.
Change in pain
时间窗: Baseline, 60 minutes post injection
Measured using self-reported Numerical Rating Scale (NRS) where 0=no pain and 10=worst pain.
次要结局
- Step Count(5 days post-injection)
- Change in disability(Baseline, 5 days post-injection)
- Change in Pressure-Pain Algometry(Baseline, 5 days post-injection)
研究者
Cole W. Cheney
Principal Investigator
Mayo Clinic