Ultra Low Frequency Neuromodulation for Nociceptive Chronic Low Back Pain

NCT06763653 | Recruiting DMC FDA Device

• 1 other identifier: PMH-006
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Nociceptive Pain; Axial Back Pain

Keywords

Neuromodulation; Spinal cord stimulation; Chronic low back pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Composite of back pain relief measured by VAS and functional improvement measured by ODI at 6 months

  6 months

• Back pain VAS responder rate at 6 months

  6 months

• Functional improvement measured by ODI at 6 months

  6 months

• Average change in back pain VAS at 3 months

  3 months

• Average change in back pain VAS at 6 months

  6 months

Study Arms (2)

ULF therapy plus CMM

EXPERIMENTAL

An implanted SCS device delivering ultra low frequency neuromodulation

Device: ULF therapy; Other: CMM

CMM alone

ACTIVE COMPARATOR

Conventional medical management

Other: CMM

Interventions

ULF therapy DEVICE

ultra low frequency spinal cord stimulation

ULF therapy plus CMM

CMM OTHER

conventional medical management

CMM alone; ULF therapy plus CMM

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Symptoms have failed to respond adequately to conservative therapies, including: physical therapy/exercise, medications, and interventional therapies.
• Back pain greater than leg pain.
• ODI score ≥30 and ≤80.
• On stable pain medications or on no pain medications.
• Considered medically stable and a suitable surgical candidate.
• Able to operate the device.
• Willing to sign the Human Research Ethics Committee (HREC)/Institutional Review Board (IRB) approved informed consent form.
• Willing and deemed capable of complying with the requirements of the study protocol, including attending all scheduled visits.
• Twenty-two (22) years of age or older.
• Able to complete questionnaires independently.

You may not qualify if:

• Have a systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study.
• Suffer from severe cognitive impairment that would impair ability to complete subject questionnaires or operation of the device.
• 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.
• Presence of spinal stenosis, structural spinal abnormality, or spinal instrumentation observed on MRI or CT that would make lead placement unsafe or untowardly difficult.
• Previous experience with neuromodulation devices for pain.
• Opioid usage with average total daily morphine equivalent dose (MED) of \>100 mg.
• Have an untreated addiction to alcohol or other drugs within 6 months of screening visit.
• Have a cardiac demand pacemaker, implanted defibrillator, or another implanted electronic device.
• Have a known hypersensitivity to any of the procedural agents or materials in the study device that is inserted into the subject.
• Have a known need for an MRI or surgery through the end of the study.
• Candidates of child-bearing potential cannot be pregnant nor plan to become pregnant during the study.
• Diagnosed with untreated malicious or malignant neoplasms or have a life expectancy of less than 1 year.
• Be participating in another interventional clinical trial.

Sponsors & Collaborators

• Presidio Medical, Inc: lead

Study Sites (3)

The International Spine Centre

Norwood, South Australia, 5067, Australia

RECRUITING

CerCare Pty Ltd

Wayville, South Australia, Australia

RECRUITING

Monash House Research Centre

Clayton, Victoria, 3168, Australia

RECRUITING

MeSH Terms

Conditions

Nociceptive Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Valerie Cimmarusti

CONTACT

+1 (626) 353-8667; vcimmarusti@presidiomedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Option to crossover to alternate treatment arm at 6 months

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 8, 2025
• Study Start: January 17, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2029
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)