Electrical Nerve Stimulation of the Ulnar Nerve

NCT ID: NCT02566616

Last Updated: 2017-04-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-04-01

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

Conditions

Cubital Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention

Cubital Tunnel Release with stimulator for nerve location

1 hour of Ulnar nerve stimulation

Group Type: EXPERIMENTAL

Ulnar Nerve Stimulation

Intervention Type: DEVICE

1 hour of continued stimulation of the ulnar nerve using a hand held stimulator

Non-Intervention

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

Group Type: ACTIVE_COMPARATOR

Ulnar Nerve Stimulation

Intervention Type: DEVICE

1 hour of continued stimulation of the ulnar nerve using a hand held stimulator

Interventions

Ulnar Nerve Stimulation

1 hour of continued stimulation of the ulnar nerve using a hand held stimulator

Intervention Type: DEVICE

Other Intervention Names

Stimulation

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jovito Angeles, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago Medical Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

14-0646

Identifier Type: -

Identifier Source: org_study_id