Using Ultra Low Frequency Neuromodulation to Treat Chronic Low Back Pain

A Prospective, Multi-Center, Randomized, Controlled Trial to Compare the Safety and Efficacy of Ultra Low Frequency Spinal Cord Stimulation Plus Conservative Medical Management (CMM) to CMM Alone in the Treatment of Chronic Axial Low Back Pain With Prominent Nociceptive Etiology - The FULFILL Study

This study is testing if a new low-frequency therapy can help adults with chronic low back pain feel better compared to standard treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 303 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Presidio Medical, Inc (Industry-sponsored)
• Locations: 3 sites (Norwood, South Australia and 2 other locations)
• Trial ID: NCT06763653 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of Ultra Low Frequency (ULF) neuromodulation in treating nociceptive chronic low back pain in adults. Participants will be randomly assigned to receive either ULF therapy combined with conventional medical management or conventional treatments alone. The study will monitor participants over a 24-month period, assessing pain relief and any unexpected medical issues that arise. The primary endpoint will be evaluated at 3 months, with an option for participants to switch treatment arms if necessary.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 and older with chronic, intractable nociceptive axial low back pain that has not adequately responded to conservative treatments.

Not a fit: Patients with systemic conditions that are not stabilized or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce chronic low back pain for patients who have not responded to traditional therapies.

How similar studies have performed: While the approach of ULF neuromodulation is relatively novel, similar neuromodulation techniques have shown promise in other studies.

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.

Where this trial is running

Norwood, South Australia and 2 other locations

• The International Spine Centre — Norwood, South Australia, Australia (Recruiting)
• CerCare Pty Ltd — Wayville, South Australia, Australia (Recruiting)
• Monash House Research Centre — Clayton, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Valerie Cimmarusti

Conditions Nociceptive Pain; Axial Back Pain; Neuromodulation; Spinal cord stimulation; Chronic low back pain