Electrical Nerve Stimulation of the Ulnar Nerve

Not Applicable

Withdrawn

• Conditions: Cubital Tunnel Syndrome
• Interventions: Device: Ulnar Nerve Stimulation

• Registration Number: NCT02566616
• Lead Sponsor: University of Chicago

Brief Summary

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

1. 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

2. 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

3. 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.

4. 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

5. Data will be compared pre and postoperatively

Study Timeline

• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-02
• Study Start: 2015-11
• Status Verified: 2017-04
• Primary Completion: 2017-04-01
• Study Completion: 2017-04-01
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Ulnar Nerve Stimulation	Cubital Tunnel Release with stimulator for nerve location 1 hour of Ulnar nerve stimulation
Non-Intervention	Ulnar Nerve Stimulation	Cubital Tunnel Release with stimulator for nerve location NO prolonged ulnar nerve stimulation

Primary Outcome Measures

Name	Time	Method
Patient Related Ulnar Nerve Evaluation	10 minutes	PRUNE Survey with 0-100 score

Secondary Outcome Measures

Name	Time	Method
QuickDASH	10 minutes, pre op and each post op visit	Survey
Michigan Hand Questionnaire	20 minutes, pre op and each post op visit	Survey

Trial Locations

Locations (1)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States