Electrical Nerve Stimulation of the Ulnar Nerve

Study Overview
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Brief Summary
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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?

Detailed Description
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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

Official Title
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Electrical Nerve Stimulation of the Ulnar Nerve During Cubital Tunnel Decompression Surgery: Does it Improve Long Term Functional Outcomes?

Conditions
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Cubital Tunnel Syndrome

Intervention / Treatment
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* Device: Ulnar Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria 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 Exclusion criteria 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Cubital Tunnel Release with stimulator for nerve location 1 hour of Ulnar nerve stimulation | Device: Ulnar Nerve Stimulation<br>* 1 hour of continued stimulation of the ulnar nerve using a hand held stimulator<br>* Other names: Stimulation;|
| Active Comparator: Non-Intervention<br>Cubital Tunnel Release with stimulator for nerve location NO prolonged ulnar nerve stimulation | Device: Ulnar Nerve Stimulation<br>* 1 hour of continued stimulation of the ulnar nerve using a hand held stimulator<br>* Other names: Stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Related Ulnar Nerve Evaluation | PRUNE Survey with 0-100 score | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QuickDASH | Survey | 10 minutes, pre op and each post op visit | 
| Michigan Hand Questionnaire | Survey | 20 minutes, pre op and each post op visit |