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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Chronic Low-back Pain
• Intervention / Treatment: Device: ULF SCS

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 1-year period.

• Study Type: Interventional
• Enrollment (Estimated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valerie Cimmarusti; Phone Number: +1 (626) 353-8667; Email: vcimmarusti@presidiomedical.com

Study Locations

• Australia
  • New South Wales
    • Newcastle, New South Wales, Australia
      • Recruiting
      • Genesis Research Services Pty Ltd
      • Principal Investigator: Willem Volschenk, MBCHB
      • Contact: Heather Macdonald; Phone Number: +61 2 4985 1841; Email: r.manager@genesisresearchservices.com
  • South Australia
    • Wayville, South Australia, Australia
      • Recruiting
      • CerCare Pty Ltd
      • Contact: Helen Plummer; Phone Number: +61 8 8340 7733; Email: Helen@painmedsa.com
      • Principal Investigator: Matthew Green, BMBS
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Recruiting
      • Metro Pain Research Institute
      • Contact: Maja Green, PhD; Phone Number: +61 3 9595 6181; Email: mgreen@MPRI.com.au
      • Principal Investigator: Paul Verrills, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 12 months.	Device: ULF SCS; Ultra low frequency spinal cord stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Back pain responder rate at 3 months as assessed using a visual analog scale (VAS)	A responder is defined as a participant that achieved at least 50% reduction in back pain at the follow-up compared to baseline. Responder rate is defined as the percentage of participants that were responders.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in back pain VAS at 3 months	The mean percentage change in VAS back pain intensity from baseline.	3 months
Change in back pain VAS at 6 months	The mean percentage change in VAS back pain intensity from baseline.	6 months
Change in back pain VAS at 12 months	The mean percentage change in VAS back pain intensity from baseline.	12 months
Change in leg pain VAS at 3 months	The mean percentage change in VAS leg pain intensity from baseline. Calculated only for participants who scored at least 40 out of 100mm for leg pain at baseline.	3 months
Change in leg pain VAS at 6 months	The mean percentage change in VAS leg pain intensity from baseline. Calculated only for participants who scored at least 40 out of 100mm for leg pain at baseline.	6 months
Change in leg pain VAS at 12 months	The mean percentage change in VAS leg pain intensity from baseline. Calculated only for participants who scored at least 40 out of 100mm for leg pain at baseline.	12 months
Proportion of participants with a minimal clinically important difference (MCID) as measured by Oswestry Disability Index (ODI) at 3 months	The MCID is defined as at least a 10-point improvement on ODI.	3 months
Proportion of participants with a MCID as measured by ODI at 6 months	The MCID is defined as at least a 10-point improvement on ODI.	6 months
Proportion of participants with a MCID as measured by ODI at 12 months	The MCID is defined as at least a 10-point improvement on ODI.	12 months
Change in EuroQol-5 Dimension (EQ-5D) quality of life index at 3 months	The mean change in EQ-5D index from baseline.	3 months
Change in EQ-5D quality of life index at 6 months	The mean change in EQ-5D index from baseline.	6 months
Change in EQ-5D quality of life index at 12 months	The mean change in EQ-5D index from baseline.	12 months
Proportion of participants with remission of low back pain as assessed by VAS at 6 months	Remission is defined as VAS score of 30mm or less for 6 consecutive months.	6 months
Proportion of participants with remission of low back pain as assessed by VAS at 9 months	Remission is defined as VAS score of 30mm or less for 6 consecutive months.	9 months
Proportion of participants with remission of low back pain as assessed by VAS at 12 months	Remission is defined as VAS score of 30mm or less for 6 consecutive months.	12 months
Change in sleep quality as assessed by Medical Outcomes Study Sleep Scale (MOS-SS) at 3 months	The mean change in MOS-SS index from baseline.	3 months
Change in sleep quality as assessed by MOS-SS at 6 months	The mean change in MOS-SS index from baseline.	6 months
Change in sleep quality as assessed by MOS-SS at 12 months	The mean change in MOS-SS index from baseline.	12 months

Collaborators and Investigators

• Sponsor: Presidio Medical, Inc
• Investigators: Principal Investigator: Willem Volschenk, MBCHB, Genesis Research Services; Principal Investigator: Mattew Green, BMBS, CerCare; Principal Investigator: Paul Verrills, MBBS, Metro Pain Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: April 19, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Neuromodulation; Spinal Cord Stimulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Chronic Pain
• Other Study ID Numbers: PMH-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes