Direct Current Neuromuscular Electrical Stimulation for Treatment of Peripheral Neuropathy

NeuFit

Status: Completed

Conditions: Neuropathy

Treatments: Device: TENS; Device: Neubie Direct Current Electrical Stimulation Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05442021

Pro00063515

Details and patient eligibility

About

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.

Full 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.

Participants will receive 12 treatments over 6 weeks. EMG/NCS and a neuropathy pain questionnaire will be measured at both the initial evaluation and at the completion of the final session, and will provide both quantitative and qualitative data on the severity of neuropathy symptoms.

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

148 participants in 2 patient groups

Neubie Direct Current Electrical Stimulation

Experimental group

Description:

The experimental group subjects follow with 12 sessions of physical therapy over a 6-week period which include: a 30-min foot bath session using the Neubie and 15-min of various physical therapy exercises.

Treatment:

Device: Neubie Direct Current Electrical Stimulation Device

Transcutaneous Electrical Nerve Stimulation

Other group

Description:

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.

Treatment:

Device: TENS