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.
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
Currently pregnant
Cardiac pacemaker
Active or recently treated cancer
Active or recent blood clots
Parallel
Neubie Direct Current Stimulation Device
DevicePulsed Direct Current Electrical Stimulation Device
Modified Oswestry Disability Index
MODIFIED OSWESTRY DISABILITY SCALE - Each question is scored from 0-5 (minimum to maximum). The point total from each section is summed and the then divided by the total number of questions answered and multiplied by 100 to create a percentage disability. The scores range from 0-100% with lower scores meaning less disability.
Modified Oswestry Disability Index
MODIFIED OSWESTRY DISABILITY SCALE - Each question is scored from 0-5 (minimum to maximum). The point total from each section is summed and the then divided by the total number of questions answered and multiplied by 100 to create a percentage disability. The scores range from 0-100% with lower scores meaning less disability.
Visual Analog Pain Scale
The Visual Analog Scale (VAS) for measuring pain ranges from 0-10, with 0 representing "no pain" and 10 representing "worst pain imaginable".
Visual Analog Pain Scale
The Visual Analog Scale (VAS) for measuring pain ranges from 0-10, with 0 representing "no pain" and 10 representing "worst pain imaginable".
Click on the lead sponsor to view all of their trials.
NeuFit - Neurological Fitness and Education
Lead sponsor
EA Therapeutic Health
Collaborator
Mayo Clinic
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
