MC5-A Scrambler Therapy for the Treatment of Chronic Neuropathic Extremity Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change over time in pain on the Numerical Rating Scale-11 Pain Score (NRS-11)
研究概览
简要总结
The FDA-approved MC5-A Scrambler Therapy (MC5-A ST) is an electroanalgesia device that interferes with pain signal transmission by using nerve fibers as a passive means to convey a message of normality (sans pain) to the central nervous system. While preliminary research has demonstrated its efficacy in treating chronic neuropathic pain secondary to cancer and failed back surgery syndrome, its effectiveness in treating chronic neuropathic pain secondary to traumatic musculoskeletal injuries like those experienced in combat has not been investigated. The purpose of this prospective, double-blind, randomized controlled, study is to determine if the MC5-A ST is efficacious in altering the biological, psychological, and social components of the chronic neuropathic pain experience in military Service Members (SMs) with traumatic musculoskeletal extremity injuries.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •military service members (active duty & retirees) between the ages of 18 and 79, inclusive
- •neuropathic pain symptoms present for 3 months or greater prior to entry into the study
- •rated pain intensity equal to or greater than 3 on NRS-11 pain scale
- •painful peripheral neuropathy in an extremity that is the result of a traumatic injury (post-traumatic/ post-surgical neuropathy, stump pain, entrapment neuropathy), or low back pain with radiculopathy
- •stable pain medication treatment regimen
- •able to speak and read English, understand the study procedures, and consent to study participation
排除标准
- •pacemaker or other implantable devices
- •vena cava, aneurysm clips, coronary or other vascular stents
- •pregnancy via a pregnancy test
- •history of epilepsy, brain injury, symptomatic brain metastases
- •prior celiac plexus block, or other neurolytic pain control treatment, within 4 weeks
- •wounds or skin irritation in areas where the electrodes are required to be placed
- •cardiac ischemia within the previous 6 months
- •severe arrhythmia
- •documented history of moderate or severe traumatic brain injury
- •latex allergies
- •open wound over site of chronic pain
- •unable to stop anti-epileptic medications or gabapentin over 2 weeks of MC5-A ST treatment
- •history of electroanalgesia treatment (electroacupuncture, biomodulator, TENS) over last 30 days
- •participation in the study would delay the medical board (MEB) processing of the service member off of active duty status or would delay a return to duty status to their home unit.
- •metal implants such as cardiac pacemakers, automatic defibrillators, aneurysm clips, vena cava clips and skull plates
研究组 & 干预措施
MC5-A Scrambler Therapy
MC5-A Scrambler Therapy is an electroanalgesia device that interferes with pain signal transmission by using nerve fibers as a passive means to convey a no pain message to the central nervous system. Electrodes are placed on dermatomes that correspond to the area of pain. Patient is treated for 30 minutes and given up to 10 treatment sessions.
干预措施: MC5-A Scrambler Therapy (Device)
MC5-A Scrambler Therapy Sham Device
The MC5-A Scrambler Therapy Device will be used as an active sham device in this randomized double blind study. Participants assigned to this arm will not receive active therapy.
干预措施: MC5-A Scrambler Therapy Sham Device (Device)
结局指标
主要结局
Change over time in pain on the Numerical Rating Scale-11 Pain Score (NRS-11)
时间窗: Baseline, Week 3, Week 6
次要结局
- Change over time in oral consumption of analgesic medications(Baseline, Week 3, Week 6)
研究者
Ann Marie Nayback-Beebe, PhD, RN
LTC Ann Marie Nayback-Beebe
Brooke Army Medical Center