Randomized, Double-blinded, Controlled Trial of Early-intervention TENS for the Reduction of the Prevalence and Severity of Chronic Neuropathic Pain During the First Year After Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- The Percentage of Subjects Who Develop Chronic Neuropathic Pain.
研究概览
简要总结
The purpose of this research study is to: 1) test whether transcutaneous electrical nerve stimulation (TENS) after spinal cord injury can reduce the onset of post-injury neuropathic pain; and 2) to learn more about this kind of pain and who is at risk for suffering from this type of pain after spinal cord injury. Neuropathic pain is a type of pain that occurs in about 50% of people with spinal cord injury. This type of pain is usually described as "burning" or "tingling," and is present around the level of injury and/or in areas below the level of injury. The investigators' goal is to try a non-drug treatment (TENS) that may help prevent this pain from occurring. Pain symptoms will be compared between the study participants who receive active TENS and the study participants who receive a sham TENS treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Age ≥ 18;
- •Traumatic spinal cord injury;
- •Date of injury occurring within four months of study enrollment.
排除标准
- •More than four months since date of injury;
- •Contraindications for the study intervention, transcutaneous electrical nerve stimulation (TENS),88 including:
- •Implanted electronic device such as a pacemaker;
- •Cardiovascular problems;
- •Pregnancy;
- •Epilepsy;
- •Persons with a spinal cord injury at the C2 level, as placement of TENS electrodes on the neck is not recommended;
- •Cognitive dysfunction which limits the ability of the participant to adequately understand procedures and risks.
- •Prisoners
- •Pregnant Women
- •Special populations:
- •Adults unable to consent: excluded from study
- •Individuals -who are not yet adults: individuals who are less than 18 years old will be excluded from the study
- •Pregnant women: Women who are known to be pregnant will not be recruited into the study. A pregnancy test will be administered to females prior to enrollment in TENS (or sham) treatment. Women who become pregnant before or during the 8-week TENS treatment period will be discontinued from the study. Women who become pregnant after the 8-week TENS treatment portion of the study will continue to be enrolled, and followed according to protocol guidelines (no information will be collected specifically on the pregnancy or fetus).
- •Prisoners: excluded from study
- •Neonates: not applicable
研究组 & 干预措施
Active TENS
Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.
干预措施: TENS (Device)
Sham TENS
Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation.
干预措施: Sham TENS (Other)
结局指标
主要结局
The Percentage of Subjects Who Develop Chronic Neuropathic Pain.
时间窗: 12 months
as defined by a score of ≥2 on the Spinal Cord Injury Pain Inventory (SCIPI), a self-report scale of symptoms. SCIPI has a total score ranging from 0 to 4 with scores of \>=2 screening positive for Neuropathic Pain in people with spinal cord injury
Neuropathic Pain Symptom Inventory (NPSI) Scores
时间窗: 12 months
NPSI has a total score ranging from 0 to 100 with the higher score indicating more severe symptoms of neuropathic pain
次要结局
- Pain Interference With Function(12 months)
- Number of Participants With Adverse Events(12 months)
- Depressive Symptoms(12 months)
研究者
Elizabeth Felix
Research Professor
University of Miami