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Electrical Nerve Stimulation of the Ulnar Nerve

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02566616
Acronym
ESTIM
Enrollment
0
Registered
2015-10-02
Start date
2015-11-30
Completion date
2017-04-01
Last updated
2017-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cubital Tunnel Syndrome

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

Interventions

DEVICEUlnar Nerve Stimulation

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

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Patient Related Ulnar Nerve Evaluation10 minutesPRUNE Survey with 0-100 score

Secondary

MeasureTime frameDescription
QuickDASH10 minutes, pre op and each post op visitSurvey
Michigan Hand Questionnaire20 minutes, pre op and each post op visitSurvey

Other

MeasureTime frameDescription
Pinch Strength5 minutes, pre op and each post op visitMeasure Pinch strength
EMGPre-op and 3 month post op visitElectromyelopgraph to confirm ulnar nerve neuropathy and improvement at 3 months post op
Grip strength5 minutes, pre op and each post op visitMeasure hand grip strength
Monofilament test5 minutes, pre op and each post op visitMeasure sensation on fingers
2 point discrimination5 minutes, pre op and each post op visitMeasure 2 point discrimination on fingers

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026