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Trial record 99 of 337 for:    Charcot Marie Tooth

Electrical Nerve Stimulation of the Ulnar Nerve (ESTIM)

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ClinicalTrials.gov Identifier: NCT02566616
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : October 2, 2015
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
University of Chicago

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?


Condition or disease Intervention/treatment Phase
Cubital Tunnel Syndrome Device: Ulnar Nerve Stimulation Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Electrical Nerve Stimulation of the Ulnar Nerve During Cubital Tunnel Decompression Surgery: Does it Improve Long Term Functional Outcomes?
Study Start Date : November 2015
Actual Primary Completion Date : April 1, 2017
Actual Study Completion Date : April 1, 2017


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 Name: 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 Name: Stimulation




Primary Outcome Measures :
  1. Patient Related Ulnar Nerve Evaluation [ Time Frame: 10 minutes ]
    PRUNE Survey with 0-100 score


Secondary Outcome Measures :
  1. QuickDASH [ Time Frame: 10 minutes, pre op and each post op visit ]
    Survey

  2. Michigan Hand Questionnaire [ Time Frame: 20 minutes, pre op and each post op visit ]
    Survey


Other Outcome Measures:
  1. EMG [ Time Frame: Pre-op and 3 month post op visit ]
    Electromyelopgraph to confirm ulnar nerve neuropathy and improvement at 3 months post op

  2. Monofilament test [ Time Frame: 5 minutes, pre op and each post op visit ]
    Measure sensation on fingers

  3. 2 point discrimination [ Time Frame: 5 minutes, pre op and each post op visit ]
    Measure 2 point discrimination on fingers

  4. Pinch Strength [ Time Frame: 5 minutes, pre op and each post op visit ]
    Measure Pinch strength

  5. Grip strength [ Time Frame: 5 minutes, pre op and each post op visit ]
    Measure hand grip strength



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02566616


Locations
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United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Jovito Angeles, MD University of Chicago

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02566616     History of Changes
Other Study ID Numbers: 14-0646
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Ulnar Nerve Compression Syndromes
Nerve Compression Syndromes
Cubital Tunnel Syndrome
Ulnar Neuropathies
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries