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Nociceptive PainNCT06763653

Ultra Low Frequency Neuromodulation for Nociceptive Chronic Low Back Pain

A study testing ULF therapy and CMM in people with Nociceptive Pain and Axial Back Pain, run by Presidio Medical, Inc at 3 sites in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Nociceptive Pain, Axial Back Pain
What is being tested?
ULF therapy and CMM
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
303 participants
Where
3 sitesAustralia
Study dates
17 Jan 2025to Apr 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Valerie Cimmarusti contact

+1 (626) 353-8667

vcimmarusti@presidiomedical.com

Australia3 sites, 3 recruiting

  • Monash House Research Centre

    Clayton, Victoria, 3168

    Paul Verills, MBBS, (03) 8394 0700, info@monashhouse.com.au

    Paul Verrills, MBBS

    Recruiting

  • The International Spine Centre

    Norwood, South Australia, 5067

    James Swift, +61 8 8223 4055, JSwift@3dresearch.au

    YH Yau, MBChB FRCSEd FCSHK DIMCRCSEd

    Recruiting

  • CerCare Pty Ltd

    Wayville, South Australia

    Helen Plummer, +61 8 8340 7733, helen@painmedsa.com

    Matthew Green, BMBS

    Recruiting

Other trials in Australia

About this study

Official title: 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?
Read more

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
Read the 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.

Being tested
ULF therapy, CMM
Keywords
Neuromodulation, Spinal cord stimulation, Chronic low back pain
Medical subject headings
Nociceptive Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ULF therapyDevice

    ultra low frequency spinal cord stimulation

  • CMMOther

    conventional medical management

Study groups in NCT06763653
Study groupRoleWhat they receive
ULF therapy plus CMMExperimentalAn implanted SCS device delivering ultra low frequency neuromodulation
Receives: Device: ULF therapy; Other: CMM
CMM aloneActive comparatorConventional medical management
Receives: Other: CMM

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 3 months

Secondary outcomes (12)

  1. 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).

    Measured: 6 months

  2. 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).

    Measured: 6 months

  3. 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).

    Measured: 6 months

  4. 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).

    Measured: 3 months

  5. 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).

    Measured: 6 months

  6. 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).

    Measured: 3 months

  7. 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).

    Measured: 6 months

  8. 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).

    Measured: 6 months

  9. 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).

    Measured: 6 months

  10. 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).

    Measured: 3 months

  11. 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).

    Measured: 6 months

  12. Average change in opioid dose at 6 months

    Comparison between the groups in the average change from baseline in opioid equivalent medication dosage.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2025
  2. Study start17 Jan 2025
  3. Primary completionJan 2027 (estimated)
  4. Study completionApr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Option to crossover to alternate treatment arm at 6 months
Masking
None (open label)
Enrolment
303 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06763653
Sponsor's protocol ID
PMH-006
Status last verified
Jan 2025
First submitted
1 Jan 2025
Last updated
24 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ULF therapy and CMM in people with Nociceptive Pain and Axial Back Pain, run by Presidio Medical, Inc at 3 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Valerie Cimmarusti (+1 (626) 353-8667, vcimmarusti@presidiomedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Back pain VAS responder rate at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06763653.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.

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