Function And Speed of Transection Recovery After Therapeutic Electrostimulation of Nerves
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- Two Point Discrimination
研究概览
简要总结
The goal of this clinical study is to evaluate if a period of electrical stimulation delivered during the surgical repair procedure can speed up nerve healing.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Candidate for surgical intervention under general anesthesia.
- •Require primary nerve injury repair in at least 1 digital nerve.
- •Following resection, have a resulting nerve gap of ≤ 10mm.
- •Able to complete tension-free end-to-end direct repair, or repair with a conduit, autograft, or allograft with a length ≤15mm
- •Signed and dated informed consent form.
排除标准
- •Severe comorbid conditions, such as arrhythmia or congestive heart failure, preventing surgery under general anesthesia.
- •Nerve repair occurring >1 month post-injury.
- •Incomplete nerve transection.
- •Injury requiring replantation of target digit
- •Injury distal to the distal interphalangeal joint.
- •Injury proximal to branching into the proper or common digital nerves.
- •Injuries to both digital arteries of an affected digit.
- •History of neuropathy, diabetic neuropathy, or any other known neuropathy
- •History of chronic ischemic condition of the upper extremity
- •Cognitive impairment preventing the ability to provide consent, follow post-operative instructions, or complete clinical assessments.
研究组 & 干预措施
Standard of Care Repair
Individuals will receive standard of care surgical repair of their digital nerve injury as determined by their surgeon.
干预措施: Digital Nerve Repair (Procedure)
Repair + Therapy
During the surgical repair for digital nerve injury (standard of care), a 10 minute dose of therapeutic electrical stimulation will be delivered during surgery.
干预措施: Brief Electrical Stimulation Therapy (Device)
Repair + Therapy
During the surgical repair for digital nerve injury (standard of care), a 10 minute dose of therapeutic electrical stimulation will be delivered during surgery.
干预措施: Digital Nerve Repair (Procedure)
结局指标
主要结局
Two Point Discrimination
时间窗: 2 weeks - 9 months
Evaluation of sensory function based on ability to discern two point of contact for different distances between the contacts (2-15mm). Evaluated at each follow-up visit.
次要结局
- Semmes-Weinstein Monofilament Test(2 weeks - 9 months)
- Visual Analog Scale (VAS)(2 weeks - 9 months)
- quick Disabilities of Arm, Hand, and Shoulder (quickDASH)(2 weeks - 9 months)
- Michigan Hand Outcomes Questionnaire (MHQ)(2 weeks - 9 months)