NCT07659743尚未招募不适用
A Randomized, Double-blind, Sham-controlled, Parallel-group Trial Designed to Evaluate the Efficacy of BreEStim in Managing Neuropathic Pain After Spinal Cord Injury (SCI)
The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2026年10月1日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
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 sham BreEStim and Transcutaneous Electrical Nerve Stimulation (TENS) in management of neuropathic pain in patients after spinal cord injury (SCI).
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)
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •has a history of SCI > 1 year
- •has a DN4 (Douleur Neuropathique en 4 Questions) score of 4 or greater
- •has neuropathic pain >3 months
- •is stable on oral pain medications at least one month
- •Able to tolerate BreEStim treatment for 1 minute
排除标准
- •is on a mechanical ventilator
- •is currently having active urinary tract infection (UTI)
- •does not have any residual sensation in the arms
- •has other pain (musculoskeletal, visceral etc.), but not neuropathic, e.g., shoulder pain from wheelchair use
- •has a pacemaker to avoid possible side effect of electrical stimulation
- •is not able to follow commands, or to give consent
- •has asthma or other pulmonary disease
- •has a history of cardiac pathology, implanted pacemakers, or current use of rhythm altering medication like beta-blockers
- •has baclofen pump or deep brain implants
- •has respiratory tract/sinus infection and rhinorrhea
- •has low motor neuron injury that no responses will be triggered by electrical stimulation
- •has severe mental disorders (e.g., depression, substance abuse) and is receiving active treatment and frequent monitoring
- •is not medically stable
研究组 & 干预措施
Active BreEStim Treatment
Experimental
干预措施: Active BreEStim Treatment (Device)
The transcutaneous electrical nerve stimulation (TENS) Treatment
Active Comparator
干预措施: The TENS Treatment (Device)
Sham BreEStim Treatment
Sham Comparator
干预措施: Sham BreEStim Treatment (Device)
结局指标
主要结局
未指定
次要结局
- the difference in the percentage of responders between active BreEStim and Sham BreEStim groups(Baseline, 10-15 minutes after intervention)
- the difference in the percentage of responders between between active BreEStim and transcutaneous electrical nerve stimulation (TENS) groups.(Baseline, 10-15 minutes after intervention)
研究者
Sheng Li
Professor
The University of Texas Health Science Center, Houston
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Effects of Breathing Exercises on Cognition in Older AdultsOlder Adults (65 Years and Older)CognitionBalance Control in ElderlyFall Prevention in Healthy AgingNCT07505914Istanbul University - Cerrahpasa40
尚未招募
不适用
Effects of Controlled Breathing Added to Therapeutic Exercise in Multiple MyelomaMultiple MyelomaNCT07312942Universidad Complutense de Madrid32
已完成
不适用
Breathing Exercises Guided by Student Midwives During LaborNCT07357246Antalya Bilim University90
尚未招募
不适用
Effect of Stacked Breathing vs Conventional Chest Physiotherapy on Lung Function in COPD PatientsCTRI/2025/07/091448Dr Yash Bhandari30
尚未招募
不适用
Effects of Controlled Breathing on Cardiorespiratory Variables in Multiple MyelomaNCT07376733Universidad Complutense de Madrid26