Pain Detecting and Analgesic Stimulating Device on Low Back Pain

The Effects of a Pain Detecting and Analgesic Stimulating Device on Low Back Pain Patients' Clinical Outcomes

Purpose of study is to test in a randomized controlled trial (RCT) the effects of the Nervomatrix device on various clinical outcomes of patients with low back pain, as well as its mechanisms of action.

This will be a matched randomized-controlled trial - RCT. Using random numbers from a random number generator, pairs of patients will be randomized to either the Nervomatrix stimulation (experimental group) or to sham stimulation (controls). Matching of pairs will be done based on the baseline data of the primary outcomes - pain and disability, as well as on other treatments received.

Inclusion Criteria:

• chronic low back pain persisting for at least 3 months

Exclusion Criteria:

• patho-anatomical diagnosis (such as fractures, tumors, rheumatic diseases and neurological diseases)
• initiated a new conventional therapy during the study period
• pregnant
• patients having a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device