Electrical Nerve Stimulation of the Ulnar Nerve (ESTIM)

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

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?

Study Overview

• Status: Withdrawn
• Conditions: Cubital Tunnel Syndrome
• Intervention / Treatment: Device: Ulnar 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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Cubital Tunnel Release with stimulator for nerve location 1 hour of Ulnar nerve stimulation	Device: Ulnar Nerve Stimulation; 1 hour of continued stimulation of the ulnar nerve using a hand held stimulator; Other Names: Stimulation
ACTIVE_COMPARATOR: Non-Intervention; Cubital Tunnel Release with stimulator for nerve location NO prolonged ulnar nerve stimulation	Device: Ulnar Nerve Stimulation; 1 hour of continued stimulation of the ulnar nerve using a hand held stimulator; Other Names: Stimulation

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
EMG	Electromyelopgraph to confirm ulnar nerve neuropathy and improvement at 3 months post op	Pre-op and 3 month post op visit
Monofilament test	Measure sensation on fingers	5 minutes, pre op and each post op visit
2 point discrimination	Measure 2 point discrimination on fingers	5 minutes, pre op and each post op visit
Pinch Strength	Measure Pinch strength	5 minutes, pre op and each post op visit
Grip strength	Measure hand grip strength	5 minutes, pre op and each post op visit

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Jovito Angeles, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (ACTUAL): April 1, 2017
• Study Completion (ACTUAL): April 1, 2017

Study Registration Dates

• First Submitted: September 30, 2015
• First Submitted That Met QC Criteria: September 30, 2015
• First Posted (ESTIMATE): October 2, 2015

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Ulnar Nerve Compression Syndromes; Ulnar Neuropathies; Cubital Tunnel Syndrome
• Other Study ID Numbers: 14-0646