Electrical Nerve Stimulation of the Ulnar Nerve (ESTIM)

The University of Chicago

Status: Withdrawn

Conditions: Cubital Tunnel Syndrome

Treatments: Device: Ulnar Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02566616

14-0646

Details and patient eligibility

About

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?

Full 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

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Device: Ulnar Nerve Stimulation

Non-Intervention

Active Comparator group

Description:

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

Treatment:

Device: Ulnar Nerve Stimulation