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Electrical Nerve Stimulation of the Ulnar Nerve (ESTIM)

Primary Purpose

Cubital Tunnel Syndrome

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ulnar Nerve Stimulation
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cubital Tunnel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Chicago Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Non-Intervention

Arm Description

Cubital Tunnel Release with stimulator for nerve location 1 hour of Ulnar nerve stimulation

Cubital Tunnel Release with stimulator for nerve location NO prolonged ulnar nerve stimulation

Outcomes

Primary Outcome Measures

Patient Related Ulnar Nerve Evaluation
PRUNE Survey with 0-100 score

Secondary Outcome Measures

QuickDASH
Survey
Michigan Hand Questionnaire
Survey

Full Information

First Posted
September 30, 2015
Last Updated
April 3, 2017
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT02566616
Brief Title
Electrical Nerve Stimulation of the Ulnar Nerve
Acronym
ESTIM
Official Title
Electrical Nerve Stimulation of the Ulnar Nerve During Cubital Tunnel Decompression Surgery: Does it Improve Long Term Functional Outcomes?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled
Study Start Date
November 2015 (undefined)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
April 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cubital Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Cubital Tunnel Release with stimulator for nerve location 1 hour of Ulnar nerve stimulation
Arm Title
Non-Intervention
Arm Type
Active Comparator
Arm Description
Cubital Tunnel Release with stimulator for nerve location NO prolonged ulnar nerve stimulation
Intervention Type
Device
Intervention Name(s)
Ulnar Nerve Stimulation
Other Intervention Name(s)
Stimulation
Intervention Description
1 hour of continued stimulation of the ulnar nerve using a hand held stimulator
Primary Outcome Measure Information:
Title
Patient Related Ulnar Nerve Evaluation
Description
PRUNE Survey with 0-100 score
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
QuickDASH
Description
Survey
Time Frame
10 minutes, pre op and each post op visit
Title
Michigan Hand Questionnaire
Description
Survey
Time Frame
20 minutes, pre op and each post op visit
Other Pre-specified Outcome Measures:
Title
EMG
Description
Electromyelopgraph to confirm ulnar nerve neuropathy and improvement at 3 months post op
Time Frame
Pre-op and 3 month post op visit
Title
Monofilament test
Description
Measure sensation on fingers
Time Frame
5 minutes, pre op and each post op visit
Title
2 point discrimination
Description
Measure 2 point discrimination on fingers
Time Frame
5 minutes, pre op and each post op visit
Title
Pinch Strength
Description
Measure Pinch strength
Time Frame
5 minutes, pre op and each post op visit
Title
Grip strength
Description
Measure hand grip strength
Time Frame
5 minutes, pre op and each post op visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jovito Angeles, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

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Electrical Nerve Stimulation of the Ulnar Nerve

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