Pulsed Direct Current Electrical Stimulation for Treatment of Low Back Pain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorNeuFit - Neurological Fitness and Education

About this trial

The goal of this interventional clinical trail is to determine the efficacy of the use of the Neubie pulsed direct current electrical stimulation device for the treatment of participants experiencing mechanical low back pain. The main question it aims to answer is:

Does treatment with the Neubie improve symptoms and time to resolution of back pain compared to standard of care?

Researchers will compare a 12 session treatment physical therapy regimen using the Neubie to standard of care to see if there is a difference in symptom severity and time to resolution.

Participants will:

* Visit the clinic 2 times a week to undergo active physical therapy treatments with or without electrical stimulation from the Neubie. * Undergo testing and fill out surveys on evaluation and final session on quality of life, disability, pain, and spinal mobility.

Eligibility criteria

Qualifiers

Must show evidence of axial mechanical low back pain at least 3/10 on visual analog scale, without radiation to the lower limbs. Pain has to have been present for at least two weeks or diagnosed as chronic .

Normal lower limb strength

Able to attend twice weekly physical therapy visis for up to 6 weeks

18 years of age, or older

Disqualifiers

Currently pregnant

Cardiac pacemaker

Active or recently treated cancer

Active or recent blood clots

Trial design

Treatments tested in this trial

  • Neubie Direct Current Stimulation Device

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

NeuFit - Neurological Fitness and Education

Lead sponsor

EA Therapeutic Health

Collaborator

Mayo Clinic

Collaborator