Effectiveness and Safety of Transcutaneous Electrical Stimulation With 40 kHz Alternating Currents in People With Spinal Cord Injury and Neuropathic Pain. A Randomised, Double-blind, Parallel Pilot Study With Placebo Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain perception - NPSI
研究概览
简要总结
To investigate the safety and effectiveness of transcutaneous electrical stimulation with 40 kHz alternating currents combined with standard treatment compared to placebo electrical stimulation plus standard treatment for neuropathic pain in people with spinal cord injury.
详细描述
Neuropathic pain affects more than a third of people with spinal cord injuries, reducing their quality of life, and the effectiveness of current treatments is limited. The latest research on healthy volunteers has shown that transcutaneous electrical stimulation with high-frequency blocking currents could have a potential effect on pain, proving to be a safe intervention.
To investigate the safety and effectiveness of transcutaneous electrical stimulation with 40 kHz alternating currents combined with standard treatment compared to placebo electrical stimulation plus standard treatment for neuropathic pain in people with spinal cord injury.
Design: Parallel, randomised, double-blind, placebo-controlled pilot clinical trial.
Participants and location: People with spinal cord injury over the age of 18, with a history of more than three months, neuropathic pain at the level of injury and/or below the level of injury, and pain intensity ≥ 30 mm on the visual analogue scale (VAS) for pain. Participants with any contraindications for the application of transcutaneous electrical stimulation will be excluded. The study will be conducted at the National Hospital for Paraplegics in Toledo.
Intervention: Participants will be randomly assigned to two intervention groups:
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, Outcomes Assessor)
盲法说明
Blinding of participants will be performed using the same equipment, electrodes, and placement for the real or sham stimulation treatments. In addition, both the participants and the outcome assessor will not have a view of the equipment screen.
Blinding of the outcome assessor will be performed using different team members for randomization of the interventions (Researcher 1), intervention (Researcher 2), evaluation (Researcher 3), and statistical analysis (Researcher 4). Randomization will be kept hidden from participants and research team members and only the researcher who will deliver the intervention (Researcher 2) will know the group assignment. Successful blinding of participants and evaluator will be analyzed.
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
- •People with spinal cord injuries of any aetiology affecting the D1 spinal cord level or lower (paraplegia)
- •With injury grade A, B, C, or D according to the ASIA (American Spinal Injury Association) Impairment Scale (AIS)
- •Time since spinal cord injury ≥ 3 months
- •A score of ≥ 4 points on the Dolour Neuropathique 4 (DN4) scale
- •Neuropathic pain at the level of the injury (within the dermatome at that level and up to three dermatomes below) and/or below the level of the injury (more than three dermatomes below)
- •Duration of pain ≥ 1 month
- •Average pain perception score ≥ 30 mm on the visual analogue scale (VAS) in the week prior to eligibility, with a daily record of 5 days (Monday to Friday) in the morning.
- •Be able to understand instructions and assessment tools
- •Agree to participate in the study and sign the informed consent form
排除标准
- •Cauda equina injuries
- •Brain injuries or other central nervous system injuries concomitant with spinal cord injury
- •A value of 100 mm in any of the daily records collected in the week prior to eligibility
- •Having any contraindications for the application of transcutaneous electrical stimulation: cardiac pacemaker or any other implanted electrical device, epilepsy, pregnancy, active malignant tumours in the area of application of the stimulation, and wounds or skin damage in the area of stimulation
- •History of psychiatric illness
- •Major depression
- •Spinal cord injury caused by autolysis
- •Changes in medication prescribed for the treatment of pain and spasticity during the study
- •Acute nociceptive pain in any area of the body during the study
研究组 & 干预措施
Experimental: 40 kHz
Alternating current stimulation with a 40kHz frequency with a transcutaneous approach, 20 minutes for each intervention.
干预措施: Active group 40 kHz (Device)
Sham stimulation
Sham stimulation via transcutaneous approach will be delivered only for the first 30 seconds, following the same procedures as the 40kHz group.
干预措施: Sham intervention (Device)
结局指标
主要结局
Pain perception - NPSI
时间窗: Prior to the intervention (Baseline), during the intervention after five sessions (Day 5), after the intervention (Day 10) and one week after the end of the intervention (Day 15)
It will be assessed using the Spanish version of the Neuropathic Pain Symptom Inventory (NPSI), and the result will be taken as the change from baseline at different time points. This questionnaire has a score ranging from 0 to 100 points, with a higher score indicating greater severity of neuropathic pain symptoms. Regarding the psychometric properties of this questionnaire, it has been shown that the areas under the receiver operating characteristic curves were greater than 0.85 and all reliability coefficients were greater than 0.70.
次要结局
- Pain perception - VAS(Baseline (-5 to 0 days), week 1 treatment (days 1-5), week 2 treatment (days 6-10) and post-treatment week (days 11-15).)
- Change in pain threshold evoked by mechanical stimuli(Prior to the intervention (Baseline), during the intervention after five sessions (Day 5), after the intervention (Day 10) and one week after the end of the intervention (Day 15))
- Change in pain threshold evoked by thermal (cold and heat) stimuli(Prior to the intervention (Baseline), during the intervention after five sessions (Day 5), after the intervention (Day 10) and one week after the end of the intervention (Day 15))
- Patient's Overall Impression of Change(During the intervention after five sessions (Day 5), after the intervention (Day 10) and one week after the end of the intervention (Day 15))
- Percentage of participants responding to treatment(Baseline (-5 to 0 days), week 1 treatment (days 1-5), week 2 treatment (days 6-10) and post-treatment week (days 11-15).)
- Pain interference with sleep(Baseline (-5 to 0 days), week 1 treatment (days 1-5), week 2 treatment (days 6-10) and post-treatment week (days 11-15).)
- Spasticity(Prior to the intervention (Baseline), during the intervention after five sessions (Day 5), after the intervention (Day 10) and one week after the end of the intervention (Day 15))
- Frequency of spasms(Prior to the intervention (Baseline), during the intervention after five sessions (Day 5), after the intervention (Day 10) and one week after the end of the intervention (Day 15))
- Adverse events(Week 1 treatment (days 1-5), week 2 treatment (days 6-10))