Electrical Nerve Stimulation of the Ulnar Nerve

Cubital Tunnel Syndrome Clinical Trial

— ESTIM  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02566616
• Other study ID #: 14-0646
• Status: Withdrawn
• Phase: N/A
• First received: September 30, 2015
• Last updated: April 3, 2017
• Start date: November 2015
• Est. completion date: April 1, 2017

Study information

• Verified date: April 2017
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cubital Tunnel Syndrome

Intervention

Device:
• Ulnar Nerve Stimulation
1 hour of continued stimulation of the ulnar nerve using a hand held stimulator

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	EMG	Electromyelopgraph to confirm ulnar nerve neuropathy and improvement at 3 months post op	Pre-op and 3 month post op visit
Other	Monofilament test	Measure sensation on fingers	5 minutes, pre op and each post op visit
Other	2 point discrimination	Measure 2 point discrimination on fingers	5 minutes, pre op and each post op visit
Other	Pinch Strength	Measure Pinch strength	5 minutes, pre op and each post op visit
Other	Grip strength	Measure hand grip strength	5 minutes, pre op and each post op visit
Primary	Patient Related Ulnar Nerve Evaluation	PRUNE Survey with 0-100 score	10 minutes
Secondary	QuickDASH	Survey	10 minutes, pre op and each post op visit
Secondary	Michigan Hand Questionnaire	Survey	20 minutes, pre op and each post op visit