The Effect of Pre-operative And/or Post-operative Electrical Stimulation on Enhancing Regeneration of Peripheral Sensory Nerve Regeneration in Human Hand, a Double Blind Randomized Controlled Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Sensory nerve conduction studies
研究概览
简要总结
Traumatic injury to the peripheral nerves is most common in the young population with high associated costs to the patient, as well as to society. These range from acute healthcare cost to loss of productivity and rehabilitation. Despite major efforts in improving surgical technique, functional outcome has not significantly improved in the past thirty years. Irreversible denervation, atrophy of target muscles, and deranged sensation secondary to slow or aberrant axonal outgrowth remains a significant challenge. Although pre-operative conditioning of the injured peripheral nerve with electrical stimulation has shown promise in animal studies, it has not been tested in humans.
In animal studies, pre-operative conditioning with electrical stimulation (ES) of the injured peripheral nerves promoted peripheral nerve regeneration in both sensory and motor fibres. We propose to conduct a clinical trial comparing 3 different treatments of complete digital nerve laceration before and after surgical repair. Participants will be randomized to one of three treatment arms: i) pre and post operative electrical stimulation, ii) pre-operative electrical stimulation alone , or iii) control group that receives sham pre and post-operative electrical stimulation. We will evaluate the effect of pre-operative electrical stimulation on axonal regeneration, as well as determine whether there is an additive effect of pre and post-operative electrical stimulation on sensory nerve axonal regeneration.
详细描述
Purpose:
The purpose of this research study is to determine the effect of pre-operative electrical stimulation (ES) on sensory nerve regeneration in the digital nerves that have been traumatically transected and subsequently surgically repaired.
Hypothesis:
Based on previous animal and human research, we hypothesize that pre-operative ES will result in significant improvement of sensory nerve regeneration in the hand compared to surgery alone after a traumatic digital nerve laceration. Additionally, we hypothesize that pre-operative along with post-operative ES will have an additive effect on sensory nerve regeneration compared to pre-operative ES and surgery alone.
Justification:
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-65
- •with a traumatic complete transection of one or more digital nerve(s) in the hand
- •and receive surgery within 2 weeks of injury.
排除标准
- •Age <18y and >65y,
- •Uncontrolled diabetes (HbA1C>8%),
- •Cognitively impaired,
- •Non-English speaking,
- •Medically unfit for general anesthetic or personally refuse GA,
- •Incomplete partial nerve lacerations,
- •Crush injury,
- •Concomitant bone injury in the same digit of nerve injury,
- •Large nerve gap requiring graft, conduit or extreme joint flexion,
- •Injury>14days prior to surgical repair,
- •Patients unable to comply with 6 month follow-up.
研究组 & 干预措施
Pre-operative stimulation
Patients randomized to this group will receive 1 hour of continuous electrical stimulation three days prior to scheduled surgical date. The frequency will be fixed at 20Hz and the voltage and duration of electrical pulses will be sequentially increased to the maximum tolerable limit. As the nerve becomes accustomed to the sensation of the stimulation, the voltage is increased to the next tolerable threshold and this is repeated throughout the one-hour period. Once the stimulation is complete, the stimulator is detached and the patient is informed of the surgical date. The wires are taken out at the conclusion of the pre-operative appointment. These patients will have fine gauge wires for post-operative sham stimulation implanted at the time of surgery. In the post-operative recovery room the stimulator is attached to their wires. However, the voltage will only be increased to a level they are able to sense.
干预措施: Electrical Stimulation (Procedure)
Sham stimulation
These patients will have the stimulator attached to their wires 3 days prior to scheduled surgical date and postoperatively as were in the previous groups. However, the voltage will only be increased to a level they are able to sense. The stimulator was then be turned off without the patients' knowledge. All connections are left in place for anhour duration. These patients will similarly have their wires removed after the conclusion of their pre-operative appointment and at the first post-operative follow-up within 1 week of surgery.
干预措施: Sham Stimulation (Procedure)
Pre and Post-operative stimulation
Patients randomized to this group will receive 1 hour of continuous electrical stimulation three days prior to scheduled surgical date and then again immediately post operatively. The frequency will be fixed at 20Hz and the voltage and duration of electrical pulses will be sequentially increased to the maximum tolerable limit. As the nerve becomes accustomed to the sensation of the stimulation, the voltage is increased to the next tolerable threshold and this is repeated throughout the one-hour period. Patients randomized to this group will also receive 1 hour of continuous electrical stimulation post-operatively. These patients will have fine gauge wires for post-operative stimulation implanted at the time of surgery. In the post-operative recovery room the stimulator is attached to their wires. The frequency will be fixed at 20Hz and the voltage and duration of electrical pulses will be sequentially increased to the maximum tolerable limit for one hour.
干预措施: Electrical Stimulation (Procedure)
结局指标
主要结局
Sensory nerve conduction studies
时间窗: Change from baseline to 6 months
An electromyography technique used to analyze sensory nerve recovery of the digital nerve.
次要结局
- CASE (Computer assisted Sensory Examination)(Baseline, 1,2,3,4,5,6 months)
- Cold temperature detection threshold(Baseline, 1,2,3,4,5,6 months)
- Semmes-Weinstein Monofilaments(Baseline, 1,2,3,4,5,6 months)
- DASH questionnaire(Baseline, 1,2,3,4,5,6 months)
- Two Point Discrimination Disk(Baseline, 1,2,3,4,5,6 months)
- Vibration Threshold Testing(Baseline, 1,2,3,4,5,6 months)