This study is evaluating a new therapeutic use of electrical stimulation to promote nerve healing and improve functional recovery following surgical intervention for peripheral nerve injury in arm. Participants will be randomized into one of two groups, treatment or control, with all participants receiving standard of care treatment for the nerve injury. The treatment group will also receive a single dose of the therapeutic stimulation during the surgical intervention for their nerve injury.
Preliminary research has shown that delivering a brief period of electrical stimulation following nerve repair promotes nerve healing and functional recovery. This pilot study is investigating the use of a single dose of therapeutic electrical stimulation to promote nerve healing. The therapy is delivered as part of the surgical intervention to address peripheral nerve injury in the arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Single use medical device, consisting of electric stimulator and intraoperative lead. Therapy consists of single, 10 minute dose delivered proximal to site of decompression/repair
The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery
Columbus, Ohio, United States
RECRUITINGChange in Motor Recovery assessed using the Medical Research Council (MRC) motor grading
Grading of muscle strength on 0 to 5 scale, with higher score representing greater function.
Time frame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
Grip Strength
Maximum grip strength.
Time frame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
Lateral Pinch Strength
Maximum lateral pinch.
Time frame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
2-point discrimination
Evaluation of sensory function, measuring tactile discrimination.
Time frame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
Semmes-Weinstein Monofilament Testing
Evaluation of sensory function, measuring pressure detection threshold.
Time frame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
Patient Reported Outcome Measurement System (PROMIS) Upper Extremity Function
Questionnaire providing patient reported estimate of upper extremity function on a 0-100 scale with \>50 representing greater normal function.
Time frame: Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
Patient Reported Outcome Measurement System (PROMIS) Pain Interference
Questionnaire providing patient reported estimate of interference of pain on daily activities on a 0-100 scale with \>50 representing greater than normal pain interference on daily activities.
Time frame: Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
quick Disabilities of thee Arm, Shoulder, and Hand (DASH) questionnaire
Questionnaire providing patient reported estimate upper extremity function. The score ranges from 0 (no disability) to 100 (most severe disability).
Time frame: Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
Electromyography (EMG)
Measurement of the electrical activity in a muscle.
Time frame: 4 months, 6 months, and 8 months
Motor Unit Number Estimation (MUNE)
Estimate of the number of motor units within the muscle based on recorded electrical activity.
Time frame: 4 months, 6 months, and 8 months
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