Clinical trial NCT02566616: Electrical Nerve Stimulation of the Ulnar Nerve
Official title: Electrical Nerve Stimulation of the Ulnar Nerve During Cubital Tunnel Decompression Surgery: Does it Improve Long Term Functional Outcomes?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cubital Tunnel Syndrome
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2015-10-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Patient Related Ulnar Nerve Evaluation
timeFrame: 10 minutes
Secondary outcomes:
measure: QuickDASH
timeFrame: 10 minutes, pre op and each post op visit
measure: Michigan Hand Questionnaire
timeFrame: 20 minutes, pre op and each post op visit
Other outcomes:
measure: EMG
timeFrame: Pre-op and 3 month post op visit
measure: Monofilament test
timeFrame: 5 minutes, pre op and each post op visit
measure: 2 point discrimination
timeFrame: 5 minutes, pre op and each post op visit
measure: Pinch Strength
timeFrame: 5 minutes, pre op and each post op visit
measure: Grip strength
timeFrame: 5 minutes, pre op and each post op visit
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Jovito Angeles, MD
role: PRINCIPAL_INVESTIGATOR
References: