Ultra Low Frequency Neuromodulation for Nociceptive 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

The goal of this clinical trial is to learn if Ultra Low Frequency (ULF) neuromodulation works to treat nociceptive chronic low back pain in adults. It will also evaluate the safety of ULF therapy. The main questions it aims to answer are:

• Does ULF neuromodulation reduce chronic low back pain?
• What, if any, unexpected medical problems do participants experience when treated with ULF neuromodulation?

Researchers will compare ULF therapy to conventional treatments for chronic low back pain. Participants will:

• Be randomly assigned to either the study device or to conventional medical treatments
• Undergo standard surgical procedures to place the study device if assigned to the device arm
• Attend regular clinic visits over 24 months for checkups and data collection

Study Overview

• Status: Recruiting
• Conditions: Nociceptive Pain; Axial Back Pain
• Intervention / Treatment: Device: ULF therapy; Other: CMM

Detailed Description

This is a prospective, multi-center, randomized, controlled trial in which subjects with chronic, intractable axial low back pain with prominent nociceptive features will be randomized 2:1 into either Ultra Low Frequency (ULF) therapy combined with conventional medical management (CMM) or CMM alone. The purpose of this study is to compare the safety and efficacy of ULF neuromodulation to CMM in Subjects with chronic, intractable axial low back pain with prominent nociceptive features over a 24-month period.

Subjects assigned to CMM will continue with further optimization of the best available medical treatments. Subjects assigned to ULF therapy will proceed with a temporary trial phase and be eligible for permanent device implant if they experience at least 50% back pain relief. An option to cross over to the alternative treatment arm will be permitted at the 6-month timepoint for subjects who meet the criteria. The study primary endpoint will be evaluated at 3 months and follow-up will continue for 24 months total.

• Study Type: Interventional
• Enrollment (Estimated): 303
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• Australia
  • South Australia
    • Norwood, South Australia, Australia, 5067
      • Recruiting
      • The International Spine Centre
      • Contact: James Swift; Phone Number: +61 8 8223 4055; Email: JSwift@3dresearch.au
      • Contact: YH Yau, MBChB FRCSEd FCSHK DIMCRCSEd
    • Wayville, South Australia, Australia
      • Recruiting
      • CerCare Pty Ltd
      • Contact: Helen Plummer; Phone Number: +61 8 8340 7733; Email: helen@painmedsa.com
      • Contact: Matthew Green, BMBS
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Recruiting
      • Monash House Research Centre
      • Contact: Paul Verills, MBBS; Phone Number: (03) 8394 0700; Email: info@monashhouse.com.au
      • Contact: Paul Verrills, MBBS

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ULF therapy plus CMM; An implanted SCS device delivering ultra low frequency neuromodulation	Device: ULF therapy; ultra low frequency spinal cord stimulation; Other: CMM; conventional medical management
Active Comparator: CMM alone; Conventional medical management	Other: CMM; conventional medical management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Back pain VAS responder rate at 3 months	Comparison between the groups of the proportion of participants achieving at least 50% back pain relief from baseline, measured on a 10 cm visual analog scale (VAS).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of back pain relief measured by VAS and functional improvement measured by ODI at 6 months	Comparison between the groups of the proportion of participants who are both back pain responders (at least 50% relief from baseline VAS) and have at least a 10 point improvement in disability from baseline as measured by Oswestry Disability Index (ODI).	6 months
Back pain VAS responder rate at 6 months	Comparison between the groups of the proportion of participants achieving at least 50% back pain relief from baseline, measured on a 10 cm visual analog scale (VAS).	6 months
Functional improvement measured by ODI at 6 months	Comparison between the groups of the proportion of participants who have at least a 10 point improvement in disability from baseline as measured by Oswestry Disability Index (ODI).	6 months
Average change in back pain VAS at 3 months	Comparison between the groups in the average percentage change from baseline in back pain intensity, measured on a 10 cm visual analog scale (VAS).	3 months
Average change in back pain VAS at 6 months	Comparison between the groups in the average percentage change from baseline in back pain intensity, measured on a 10 cm visual analog scale (VAS).	6 months
Average change in disability measured by ODI at 3 months	Comparison between the groups in the average change from baseline in disability, measured by the Oswestry Disability Index (ODI).	3 months
Average change in disability measured by ODI at 6 months	Comparison between the groups in the average change from baseline in disability, measured by the Oswestry Disability Index (ODI).	6 months
Average change in health-related quality of life assessed by EQ-5D-5L at 6 months	Comparison between the groups in the average change from baseline in health-related quality of life, measured by the EuroQol Index (EQ-5D-5L).	6 months
Back pain VAS remitter rate at 6 months	Comparison between the groups of the proportion of participants achieving back pain remission from baseline, defined as a score of 3 cm or less for 6 consecutive months, measured on a 10 cm visual analog scale (VAS).	6 months
Leg pain VAS responder rate at 3 months	Among subjects with baseline leg pain VAS of at least 5 cm, comparison between the groups of the proportion of participants achieving at least 50% leg pain relief from baseline, measured on a 10 cm visual analog scale (VAS).	3 months
Leg pain VAS responder rate at 6 months	Among subjects with baseline leg pain VAS of at least 5 cm, comparison between the groups of the proportion of participants achieving at least 50% leg pain relief from baseline, measured on a 10 cm visual analog scale (VAS).	6 months
Average change in opioid dose at 6 months	Comparison between the groups in the average change from baseline in opioid equivalent medication dosage.	6 months

Collaborators and Investigators

• Sponsor: Presidio Medical, Inc

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: January 1, 2025
• First Submitted That Met QC Criteria: January 1, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Neuromodulation; Chronic low back pain; Spinal cord stimulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Nociceptive Pain
• Other Study ID Numbers: PMH-006

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.: No