Ultra Low Frequency Neuromodulation for Nociceptive Chronic Low Back Pain

Launched by PRESIDIO MEDICAL, INC · Jan 1, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called Ultra Low Frequency (ULF) neuromodulation to see if it can help adults with chronic low back pain, which is pain that lasts for a long time and doesn’t respond well to regular treatments. The researchers want to find out if this new therapy can reduce pain and if there are any unexpected health issues that might come up during treatment. Participants will be randomly assigned to either receive the ULF therapy or conventional treatments, and those in the ULF group will have a device surgically placed to administer the therapy. Over the course of two years, participants will attend regular check-ups to monitor their progress.

To be eligible for the trial, participants must be at least 22 years old and experience significant ongoing back pain that hasn't improved with standard therapies like physical therapy or medications. They should have been on stable pain medications or none at all and should be able to complete study questionnaires independently. It’s important for potential participants to know that there are certain health conditions or treatments that would exclude them from joining the study, such as severe cognitive impairments or specific spinal issues. This trial is currently recruiting, and those interested should be willing to commit to attending all scheduled visits and follow the study guidelines.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. Symptoms have failed to respond adequately to conservative therapies, including: physical therapy/exercise, medications, and interventional therapies.
• • 3. Back pain greater than leg pain.
• • 4. ODI score ≥30 and ≤80.
• • 5. On stable pain medications or on no pain medications.
• • 6. Considered medically stable and a suitable surgical candidate.
• • 7. Able to operate the device.
• • 8. Willing to sign the Human Research Ethics Committee (HREC)/Institutional Review Board (IRB) approved informed consent form.
• • 9. Willing and deemed capable of complying with the requirements of the study protocol, including attending all scheduled visits.
• • 10. Twenty-two (22) years of age or older.
• • 11. Able to complete questionnaires independently.
• Exclusion Criteria:
• • 1. Have a systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study.
• • 2. Suffer from severe cognitive impairment that would impair ability to complete subject questionnaires or operation of the device.
• • 3. 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.
• • 4. Presence of spinal stenosis, structural spinal abnormality, or spinal instrumentation observed on MRI or CT that would make lead placement unsafe or untowardly difficult.
• • 5. Previous experience with neuromodulation devices for pain.
• • 6. Opioid usage with average total daily morphine equivalent dose (MED) of \>100 mg.
• • 7. Have an untreated addiction to alcohol or other drugs within 6 months of screening visit.
• • 8. Have a cardiac demand pacemaker, implanted defibrillator, or another implanted electronic device.
• • 9. Have a known hypersensitivity to any of the procedural agents or materials in the study device that is inserted into the subject.
• • 10. Have a known need for an MRI or surgery through the end of the study.
• • 11. Candidates of child-bearing potential cannot be pregnant nor plan to become pregnant during the study.
• • 12. Diagnosed with untreated malicious or malignant neoplasms or have a life expectancy of less than 1 year.
• • 13. Be participating in another interventional clinical trial.