Ultra Low Frequency Spinal Cord Stimulation for Chronic Low Back Pain

NCT ID: NCT05837234

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-09
• Study Completion Date: 2028-03-31

Brief Summary

The Presidio Medical Ultra Low Frequency (ULF™) Spinal Cord Stimulation (SCS) System is intended to provide pain relief to participants who have been clinically diagnosed with chronic low back pain with or without leg pain.

Detailed Description

This is a prospective, open-label, multi-center clinical trial in which participants with chronic low back pain (CLBP) with/without leg pain will be invited to enroll and undergo treatment with the ULF SCS system. The purpose of this study is to evaluate the safety and effectiveness of ULF SCS over a 3-year period.

Conditions

Chronic Pain; Chronic Low-back Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ULF SCS

Participants with chronic low back pain that is refractory to conservative care will undergo temporary trial stimulation with the ULF SCS system. Those receiving at least 50% pain relief of their chronic back pain will be eligible for a permanent device implant and followed for 24 months.

Group Type: EXPERIMENTAL

ULF SCS

Intervention Type: DEVICE

Ultra low frequency spinal cord stimulation

Interventions

ULF SCS

Ultra low frequency spinal cord stimulation

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Presidio Medical, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Willem Volschenk, MBCHB

Role: PRINCIPAL_INVESTIGATOR

Genesis Research Services

Mattew Green, BMBS

Role: PRINCIPAL_INVESTIGATOR

CerCare

Paul Verrills, MBBS

Role: PRINCIPAL_INVESTIGATOR

Monash House Research Centre

Locations

Genesis Research Services Pty Ltd

Newcastle, New South Wales, Australia

CerCare Pty Ltd

Wayville, South Australia, Australia

Monash House Research Centre

Clayton, Victoria, Australia

Countries

Australia

Other Identifiers

PMH-003

Identifier Type: -

Identifier Source: org_study_id