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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
ULF therapy
Deviceultra low frequency spinal cord stimulation
CMM
Other interventionconventional medical management
Treatment groups
303 Participants
are divided into 2 treatment groupsGroup A: ULF therapy plus CMMExperimental treatment 2 interventions
Group B: CMM aloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Back pain VAS responder rate at 3 months
Comparison between the groups of the proportion of participants achieving at least 50% back pain relief from baseline, measured on a 10 cm visual analog scale (VAS).
Time frame
3 monthsSecondary outcomes
1
Composite of back pain relief measured by VAS and functional improvement measured by ODI at 6 months
Comparison between the groups of the proportion of participants who are both back pain responders (at least 50% relief from baseline VAS) and have at least a 10 point improvement in disability from baseline as measured by Oswestry Disability Index (ODI).
Time frame
6 months2
Back pain VAS responder rate at 6 months
Comparison between the groups of the proportion of participants achieving at least 50% back pain relief from baseline, measured on a 10 cm visual analog scale (VAS).
Time frame
6 months3
Functional improvement measured by ODI at 6 months
Comparison between the groups of the proportion of participants who have at least a 10 point improvement in disability from baseline as measured by Oswestry Disability Index (ODI).
Time frame
6 months4
Average change in back pain VAS at 3 months
Comparison between the groups in the average percentage change from baseline in back pain intensity, measured on a 10 cm visual analog scale (VAS).
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov