Ultra Low Frequency Neuromodulation for Nociceptive Chronic Low Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorPresidio Medical, Inc
About this trial
The goal of this clinical trial is to learn if Ultra Low Frequency (ULF) neuromodulation works to treat nociceptive chronic low back pain in adults. It will also evaluate the safety of ULF therapy. The main questions it aims to answer are:
* Does ULF neuromodulation reduce chronic low back pain? * What, if any, unexpected medical problems do participants experience when treated with ULF neuromodulation?
Researchers will compare ULF therapy to conventional treatments for chronic low back pain. Participants will:
* Be randomly assigned to either the study device or to conventional medical treatments * Undergo standard surgical procedures to place the study device if assigned to the device arm * Attend regular clinic visits over 24 months for checkups and data collection
Eligibility criteria
Qualifiers
Chronic, intractable nociceptive axial low back pain with or without leg pain (VAS ≥6 cm for back pain over 7 days) for a minimum of 3 months.
Symptoms have failed to respond adequately to conservative therapies, including: physical therapy/exercise, medications, and interventional therapies.
Back pain greater than leg pain.
ODI score ≥30 and ≤80.
Disqualifiers
Have a systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study.
Suffer from severe cognitive impairment that would impair ability to complete subject questionnaires or operation of the device.
Diagnosed with an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance, intervention and/or ability to evaluate treatment outcome as assessed by a clinical psychologist or psychiatrist.
Presence of spinal stenosis, structural spinal abnormality, or spinal instrumentation observed on MRI or CT that would make lead placement unsafe or untowardly difficult.
Trial design
Treatments tested in this trial
- ULF therapy
- CMM
Treatment groups
303 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov