Impact of Direct Current Neuromuscular Electrical Stimulation on Physical Therapy Treatment of Peripheral Neuropathy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 148
- Locations
- 20
- Primary Endpoint
- Fibular Motor Nerve Conduction Velocity
Study Overview
Brief Summary
This study will compare two methods of electrical stimulation (alternating current and direct current) as an adjunctive therapy to treating peripheral neuropathy. Both types of electrical stimulation have been used in clinical practice for physical therapy, however direct current stimulation is much less common and there is less known about their impact on physical therapy outcomes. The aim of this project is to show the efficacy of a novel device, the Neubie direct current device, compared to traditional TENS unit, in clinical physical therapy treatment of neuropathy. Outcomes measured will include three methods of two-point discrimination, vibration sense, pain, and score on the modified Toronto Clinical Neuropathy scale.
Detailed Description
To determine the efficacy of direct current electrical stimulation (the Neubie device) on long-term symptoms and severity of neuropathy, participants will enroll in a 6-week treatment regimen at one of 9 Hands On Physical Therapy associated clinic sites listed included in application. The first session will consist of an EMG/NCS evaluation to determine severity of neuropathy and to rule out polyneuropathy, which will serve as baseline (and a within subject control) for the intervention.
Participants will then undergo a specialized neuropathy protocol that includes traditional PT therapy for neuropathy, as well as treatment with the Neubie (or traditional e-stim) both during PT exercises and as additional treatment after sessions. Subjects receive an evaluation session that includes an Electrodiagnostic Study, pain assessment, evaluation of two-point discrimination, and vibration sense.
The experimental group subjects follow with 12 sessions of physical therapy over a 6-week period which include: a 30-min foot bath session with the Neubie and 15-min of various physical therapy exercises.
The control group subjects follow with 12 sessions of physical therapy over a 6-week period which include: a 30-min footbath with TENS and 15-min of various physical therapy exercises.
At the end of the 12 sessions of treatment, subjects receive a final evaluation session that includes an Electrodiagnostic Study, pain assessment, evaluation of two-point discrimination, and vibration sense.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcomes will be assessed by clinicians at Hands on Diagnostics locations. Assessors will be blinded to which intervention participant has received.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Must have a minimum score of 1 on the modified Toronto Clinical Neuropathy Score
- •Must be able to attend weekly sessions for the 6 week period of the study (no extended travel)
- •Must be at least 18 years old.
Exclusion Criteria
- •Currently pregnant
- •Cardiac pacemaker
- •Active or recent cancer in the lower limbs
- •Active or recent blood clots in the lower limbs
- •History of epilepsy
- •No open wounds
Outcomes
Primary Outcomes
Fibular Motor Nerve Conduction Velocity
Time Frame: Pre-intervention
Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Fibular Motor Nerve.
H-Reflex
Time Frame: Pre-intervention
Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the H-Reflex.
Distal Latency
Time Frame: 6 weeks
The time in milliseconds that it takes the impulse to travel from the stimulation point at the wrist to the recording electrode.
Sural Sensory Nerve Conduction Velocity
Time Frame: 6 weeks
Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Sural Sensory Nerve.
Superficial Fibular Sensory Nerve Conduction Velocity
Time Frame: Pre-intervention
Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Superficial Fibular Sensory Nerve.
Ulnar Motor Nerve Conduction Velocity
Time Frame: 6 weeks
Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Ulnar Motor Nerve.
Ulnar Sensory Nerve Conduction Velocity
Time Frame: 6 weeks
Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Ulnar Sensory Nerve.
Tibial Motor Nerve Conduction Velocity
Time Frame: 6 weeks
Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Tibial Motor Nerve.
Tibial F-Wave
Time Frame: 6 weeks
Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Tibial F-Wave.
Secondary Outcomes
No secondary outcomes reported