NCT02566616

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?

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

1.4 years

First QC Date

September 30, 2015

Last Update Submit

April 3, 2017

Conditions

Cubital Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

  • Patient Related Ulnar Nerve Evaluation

    PRUNE Survey with 0-100 score

    10 minutes

Secondary Outcomes (2)

  • QuickDASH

    10 minutes, pre op and each post op visit

  • Michigan Hand Questionnaire

    20 minutes, pre op and each post op visit

Other Outcomes (5)

  • EMG

    Pre-op and 3 month post op visit

  • Monofilament test

    5 minutes, pre op and each post op visit

  • 2 point discrimination

    5 minutes, pre op and each post op visit

  • +2 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Device: Ulnar Nerve Stimulation

Non-Intervention

ACTIVE COMPARATOR

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

Device: Ulnar Nerve Stimulation

Interventions

Ulnar Nerve StimulationDEVICE

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

Also known as: Stimulation
InterventionNon-Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Cubital Tunnel Syndrome

Condition Hierarchy (Ancestors)

Ulnar NeuropathiesMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesUlnar Nerve Compression SyndromesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Officials

  • Jovito Angeles, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 2, 2015

Study Start

November 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

April 5, 2017

Record last verified: 2017-04

Locations

US(1)