The Effect of Pre-operative Electrical Stimulation on Peripheral Nerve Regeneration.
Peripheral Nerve Injuries, Sensory Deficit, Digital Nerve Lesion
About this trial
This is an interventional treatment trial for Peripheral Nerve Injuries
Eligibility Criteria
Inclusion Criteria:
- aged 18-65
- with a traumatic complete transection of one or more digital nerve(s) in the hand
- and receive surgery within 2 weeks of injury.
Exclusion Criteria:
- Age <18y and >65y,
- Uncontrolled diabetes (HbA1C>8%),
- Cognitively impaired,
- Non-English speaking,
- Medically unfit for general anesthetic or personally refuse GA,
- Incomplete partial nerve lacerations,
- Crush injury,
- Concomitant bone injury in the same digit of nerve injury,
- Large nerve gap requiring graft, conduit or extreme joint flexion,
- Injury>14days prior to surgical repair,
- Patients unable to comply with 6 month follow-up.
Sites / Locations
- Royal Alexandra HospitalRecruiting
- University of Alberta HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Sham Comparator
Experimental
Pre-operative stimulation
Sham stimulation
Pre and Post-operative stimulation
Patients randomized to this group will receive 1 hour of continuous electrical stimulation three days prior to scheduled surgical date. The frequency will be fixed at 20Hz and the voltage and duration of electrical pulses will be sequentially increased to the maximum tolerable limit. As the nerve becomes accustomed to the sensation of the stimulation, the voltage is increased to the next tolerable threshold and this is repeated throughout the one-hour period. Once the stimulation is complete, the stimulator is detached and the patient is informed of the surgical date. The wires are taken out at the conclusion of the pre-operative appointment. These patients will have fine gauge wires for post-operative sham stimulation implanted at the time of surgery. In the post-operative recovery room the stimulator is attached to their wires. However, the voltage will only be increased to a level they are able to sense.
These patients will have the stimulator attached to their wires 3 days prior to scheduled surgical date and postoperatively as were in the previous groups. However, the voltage will only be increased to a level they are able to sense. The stimulator was then be turned off without the patients' knowledge. All connections are left in place for anhour duration. These patients will similarly have their wires removed after the conclusion of their pre-operative appointment and at the first post-operative follow-up within 1 week of surgery.
Patients randomized to this group will receive 1 hour of continuous electrical stimulation three days prior to scheduled surgical date and then again immediately post operatively. The frequency will be fixed at 20Hz and the voltage and duration of electrical pulses will be sequentially increased to the maximum tolerable limit. As the nerve becomes accustomed to the sensation of the stimulation, the voltage is increased to the next tolerable threshold and this is repeated throughout the one-hour period. Patients randomized to this group will also receive 1 hour of continuous electrical stimulation post-operatively. These patients will have fine gauge wires for post-operative stimulation implanted at the time of surgery. In the post-operative recovery room the stimulator is attached to their wires. The frequency will be fixed at 20Hz and the voltage and duration of electrical pulses will be sequentially increased to the maximum tolerable limit for one hour.