Pain relief using ultra low frequency spinal cord stimulation for chronic low back pain

A Prospective, Open-Label, Multi-Center Trial to Evaluate the Safety and Effectiveness of Ultra Low Frequency Spinal Cord Stimulation in Patients with Chronic Low Back Pain

This study is testing a new spinal cord stimulation device to see if it can help people with chronic low back pain feel better when other treatments haven't worked.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 55 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Presidio Medical, Inc (Industry-sponsored)
• Locations: 3 sites (Newcastle, New South Wales and 2 other locations)
• Trial ID: NCT05837234 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of the Presidio Medical Ultra Low Frequency Spinal Cord Stimulation (SCS) System in patients suffering from chronic low back pain, with or without leg pain. Participants will be enrolled in a prospective, open-label, multi-center format and will receive treatment with the ULF SCS system over a two-year period. The study aims to assess how well this neuromodulation approach alleviates pain in individuals who have not found relief through conservative therapies.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with chronic low back pain that has not responded to conservative treatments for at least three months.

Not a fit: Patients who have not been diagnosed with chronic low back pain or those who are not considered good surgical candidates may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant pain relief for patients suffering from chronic low back pain.

How similar studies have performed: Other studies have shown promise with spinal cord stimulation approaches, but the ultra low frequency aspect of this method is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Diagnosed with chronic low back pain with/without leg pain (VAS ≥60mm for back pain for the past week), which has been refractory to conservative therapy for a minimum of 3 months.
2. Be on no or stable pain medications, as determined by the investigator, for at least 28 days prior to the screening visit.
3. Is currently considered medically stable as judged by investigator.
4. Able to operate the SCS device (e.g., using remote control) and charge the device appropriately.
5. Determined to be a good surgical candidate by the investigator.
6. Willing to sign the Human Research Ethics Committee (HREC) approved informed consent and deemed capable of complying with the requirements of the study protocol.
7. Willing to stay on stable medications until implantable pulse generator (IPG) activation (i.e., from IPG implant to IPG activation, except for usual postoperative medications required following IPG insertion).
8. Able to comply with study requirements and attend all scheduled visits.
9. Eighteen (18) years of age or older.
10. Literate, able to speak English and able to complete questionnaires independently.

Exclusion Criteria:

1. Diagnosis of 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 in a psychological assessment performed at Baseline.
2. Chronic pain in any area other than back or legs, such that it precludes subject's ability to assess their pain for the primary indication of chronic low back pain as determined by Investigator.
3. Previous experience with implantable neuromodulation devices (e.g., spinal cord stimulation, peripheral nerve stimulation, dorsal root ganglion stimulation).
4. Opioid usage with average total daily morphine equivalent dose (MED) of \>60 mg.
5. A known need for an MRI or surgery within a 2-week period of the screening visit through the end of the study.
6. Female candidates of childbearing potential that are pregnant (confirmed by positive urine/blood pregnancy test) or plan to get pregnant during the duration of the study.
7. Subject is participating in another interventional clinical trial.

Where this trial is running

Newcastle, New South Wales and 2 other locations

• Genesis Research Services Pty Ltd — Newcastle, New South Wales, Australia (Recruiting)
• CerCare Pty Ltd — Wayville, South Australia, Australia (Recruiting)
• Monash House Research Centre — Clayton, Victoria, Australia (Recruiting)

Study contacts

• Principal investigator: Willem Volschenk, MBCHB — Genesis Research Services
• Study coordinator: Valerie Cimmarusti

Conditions Chronic Pain; Chronic Low-back Pain; Neuromodulation; Spinal Cord Stimulation