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
Locations
Sponsors and collaborators
NeuFit - Neurological Fitness and Education
Lead sponsor
EA Therapeutic Health
Collaborator
Mayo Clinic
Collaborator