Targeted Spinal Cord Plasticity for Alleviating SCI-related Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in minimum intensity at which the sensation covers the maximum area of skin (radiating threshold, RT)
研究概览
简要总结
The purpose of the second part of the study is to examine the effect of reflex training in the leg to decrease neuropathic pain. For this, the researchers are recruiting 15 individuals with neuropathic pain due to spinal cord injury to participate in the reflex training procedure. The study involves approximately 50 visits with a total study duration of about 6.5 months (3 months for baseline and training phases followed by 1 month and 3 month follow-up visits).
详细描述
As part of the larger study of the relationship between reflexes in the leg and the presence of neuropathic pain, the researchers are also recruiting 30 individuals with spinal cord injury (SCI) total, 15 individuals with neuropathic pain due to SCI and 15 individuals without neuropathic pain. For this portion of the study, there are 2 visits. The first visit will examine cutaneous reflexes in the leg. During the second visit, the study team will assess sensation in the leg and administer questionnaires about pain, functioning, and quality of life. This portion of the study does not involve an intervention.
The study will then recruit 15 individuals who will participate in reflex training, as described in the brief summary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •neurologically stable (>1 year post SCI)
- •medical clearance to participate
- •ability to stand with or without an assistive device for at least 3 minutes at a time
- •expectation that current medication will be maintained without change for at least 3 months (stable use of anti-spasticity medication is accepted)
- •For participants with neuropathic pain, the area of neuropathic pain must include lower leg.
排除标准
- •motoneuron injury
- •known cardiac condition
- •medically unstable condition (incl. pregnancy)
- •cognitive impairment
- •uncontrolled peripheral neuropathy
- •frequent use of electrical spinal stimulation (either transcutaneous or epidural) for pain treatment
- •daily use of electrical stimulation to the leg
- •complete lack of cutaneous sensation around foot.
结局指标
主要结局
Change in minimum intensity at which the sensation covers the maximum area of skin (radiating threshold, RT)
时间窗: change from baseline to immediately after completing the training protocol, at 1 month follow up and at 3 months follow up
This is measured by slowly increasing the nerve stimulation and recording the minimum intensity of stimulation at which the sensation covers the maximum skin area). A decrease in this threshold indicates improved sensation.
Change in neuropathic pain as measured by the Neuropathic Pain Symptom Inventory (NPSI)
时间窗: Completed at baseline, start of conditioning visits 13, 19, and 25, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up
The NPSI is a self-report questionnaire that characterizes neuropathic pain symptom severity. Participants rate different symptoms of neuropathic pain on a scale of 0 (no pain) to 10 (intense pain).
Change in minimum stimulation intensity required to barely detect the sensation (perceived threshold, perT)
时间窗: change from baseline to immediately after completing the training protocol, at 1 month follow up and at 3 months follow up
This is measured by slowly increasing the nerve stimulation and recording the minimum intensity of stimulation at which the participant is barely able to perceive the sensation. A decrease in this threshold would demonstrate improved sensation.
Change in minimum intensity at which the stimulus become painful (pain threshold, PainT)
时间窗: change from baseline to immediately after completing the training protocol, at 1 month follow up and at 3 months follow up
This is measured by slowly increasing the nerve stimulation and recording the intensity of stimulation at which the stimulation first becomes painful. An increase in this threshold indicates an increased tolerance to pain.
Change in pain as measured by the McGill Pain Questionnaire (MPQ)
时间窗: Completed at baseline, start of conditioning visits 13, 19, and 25, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up
The MPQ is a self-report questionnaire that assesses quality and intensity of pain. Scores range from 0 (no pain) to 78 (severe pain).
次要结局
- Change in functional independence as measured by the Functional Independence Measure (FIM)(Completed at baseline, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up)
- Change in ability to perceive various types of sensations as indicated by Quantitative Sensory Testing (QST)(Completed at baseline, start of conditioning visits 13, 19, and 25, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up)
- Change in quality of life as measured by Spinal Cord Injury Quality of Life and Participation Questionnaire (SCI-QOL)(Completed at baseline, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up)
- Change in basic functional independence as measured by the Spinal Cord Independence Measure (SCIM III)(Completed at baseline, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up)
研究者
Aiko Thompson
Associate Professor
Medical University of South Carolina