Electrical Nerve Stimulation of the Ulnar Nerve During Cubital Tunnel Decompression Surgery: Does it Improve Long Term Functional Outcomes?
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Patient Related Ulnar Nerve Evaluation
研究概览
简要总结
Cubital tunnel syndrome is caused by compression of the ulnar nerve at the elbow. This leads to symptoms such as chronic hand weakness, numbness and pain. This is usually treated with a surgical procedure where the nerve is decompressed. Research has shown that nerve simulators speed up the recovery of nerves following injury. The purpose of our research is to examine the difference in patient outcomes after the nerve decompression surgery with and without nerve stimulation.
Our research questions is: What are the differences in long term functional outcomes of patients that have ulnar nerve decompression surgery with and without nerve stimulation?
详细描述
- Patients will be seen in University of Chicago clinics, if they are diagnosed with Cubital Tunnel Syndrome, they will be approached to be enrolled in our study
- If they fit inclusion and exclusion criteria, failed conservative management, and consent to be part of the study, they will be scheduled for Cubital Tunnel Surgery and randomized into intervention/non-intervention group
- Patients will have pre-operative subjective pain and upper extremity function surveys and objective hand strength/sensation measurements done by a blinded Occupational Therapist in University of Chicago Occupational Therapy Clinic. Patient will also have a pre-operative EMG done.
- Patient will be discharged following surgery and followed up at 6 weeks, 3 months, 6 months, 12 months. EMG will be done at 3 months and the same outcome measurements (Pain scores, PRUNE evaluation, QuickDash Questionnaire, Michigan hand Questionnaire, grip strength, sensation measurements) will be taken at each postoperative visit by the same blinded occupational therapist
- Data will be compared pre and postoperatively
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •EMG confirmed ulnar nerve neuropathy at cubital tunnel with or without these symptoms:
- •Paresthesia or numbness of the small finger and/or ring finger
- •Complaints of hand weakness
- •Exam shows positive flexion compression test at elbow and/or positive tinel's sign at the cubital tunnel
- •Failed conservative management for 6 weeks
- •○ Has completed a combination of these for 6 weeks and still has symptoms
- •Night splinting in 45-60 degrees of flexion and forearm neutral
- •Padding of elbow with an elbow pad during the day
- •Daily NSAIDs if able to take them
- •Cubital tunnel steroid injection
- •Age restriction: 18--65years old
排除标准
- •Psychiatric conditions
- •Workman's compensation patients
- •Neurologic conditions (ex. MS)
- •Inflammatory rheumatologic conditions (Connective tissues disease, RA… etc)
- •Associated elbow and upper extremity fractures
- •Previous Cubital Tunnel Surgeries
- •Previous C-Spine Surgeries
- •Pregnancy
研究组 & 干预措施
Intervention
Cubital Tunnel Release with stimulator for nerve location
1 hour of Ulnar nerve stimulation
干预措施: Ulnar Nerve Stimulation (Device)
Non-Intervention
Cubital Tunnel Release with stimulator for nerve location NO prolonged ulnar nerve stimulation
干预措施: Ulnar Nerve Stimulation (Device)
结局指标
主要结局
Patient Related Ulnar Nerve Evaluation
时间窗: 10 minutes
PRUNE Survey with 0-100 score
次要结局
- QuickDASH(10 minutes, pre op and each post op visit)
- Michigan Hand Questionnaire(20 minutes, pre op and each post op visit)