A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Average Change in Pain as Measured by the Visual Analog Scale (VAS)
研究概览
简要总结
The purpose of this study is to compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (BreEStim) and conventional electrical stimulation (EStim) in management of neuropathic phantom limb pain in patients after limb amputation after multiple sessions of treatment.
详细描述
Subjects will receive 10-session BreEStim and 10-session EStim treatment in a random order. The interval between BreEStim and EStim is at least 2 weeks. The following assessment will be made before and after
- Visual analogue scale (VAS).
- Quantitative sensory testing (QST). It includes non-invasive assessment of tactile sensation threshold (TST), electrical sensation threshold (EST), electrical pain threshold (EPT), and thermal thresholds.
- Hear rate variability (HRV). It consists of 5-minute electrocardiogram (ECG) recording before and after a treatment session.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •has phantom limb pain (PLP) after amputation of one limb, upper or lower limb;
- •has chronic pain, >3 months;
- •is stable on oral pain medications at least two weeks. (patients are allowed to continue their pain medications, i.e., no change in pain medications.)
排除标准
- •currently adjusting oral pain medications for their PLP;
- •has pain, but not PLP (e.g., from inflammation at the incision wound of the residual limb);
- •has a pacemaker, or other metal and/or implanted devices;
- •has cognitive impairment from brain injury or are not able to follow commands, or to give consent;
- •has amputation in multiple limbs;
- •have asthma or other pulmonary diseases;
- •are not medically stable;
- •have preexisting psychiatric disorders;
- •alcohol or drug abuse;
- •have a history of seizures/Epilepsy, or taking benzodiazepines, anticonvulsants, and antidepressants.
结局指标
主要结局
Average Change in Pain as Measured by the Visual Analog Scale (VAS)
时间窗: From Baseline to completion of 10 intervention sessions (about 2 weeks)
VAS Scores are recorded from 0 to 10 with 0 being "no pain" and 10 being "worst pain", a higher score indicating a higher level of pain. For each session change is reported as \[(VAS score at baseline) - (VAS Score 10 minutes after each intervention)\] - a positive value indicates that the score (and pain level) decreased. For this outcome measure we report the average change over all 10 sessions which is calculated by the sum of all divided by 10.
次要结局
- Average Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Detection Threshold (EST)(From Baseline to completion of 10 intervention sessions (about 2 weeks))
- Average Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Detection Threshold (EPT)(From Baseline to completion of 10 intervention sessions (about 2 weeks))
研究者
Sheng Li
Professor
The University of Texas Health Science Center, Houston