Chronic PainNCT05837234
Ultra Low Frequency Spinal Cord Stimulation for Chronic Low Back Pain
A study testing ULF SCS in people with Chronic Pain and Chronic Low-back Pain, run by Presidio Medical, Inc at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Chronic Low-back Pain
- What is being tested?
- ULF SCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 3 sitesAustralia
- Study dates
- 9 May 2023to Mar 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Be on no or stable pain medications, as determined by the investigator, for at least 28 days prior to the screening visit.
- Is currently considered medically stable as judged by investigator.
- Able to operate the SCS device (e.g., using remote control) and charge the device appropriately.
- Determined to be a good surgical candidate by the investigator.
- Willing to sign the Human Research Ethics Committee (HREC) approved informed consent and deemed capable of complying with the requirements of the study protocol.
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- 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).
- Able to comply with study requirements and attend all scheduled visits.
- Eighteen (18) years of age or older.
- Literate, able to speak English and able to complete questionnaires independently.
Who cannot join
- 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.
- 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.
- Previous experience with implantable neuromodulation devices (e.g., spinal cord stimulation, peripheral nerve stimulation, dorsal root ganglion stimulation).
- Opioid usage with average total daily morphine equivalent dose (MED) of >60 mg.
- A known need for an MRI or surgery within a 2-week period of the screening visit through the end of the study.
- 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.
- Subject is participating in another interventional clinical trial.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Monash House Research Centre
Clayton, Victoria, 3168
Genesis Research Services Pty Ltd
Newcastle, New South Wales
CerCare Pty Ltd
Wayville, South Australia
About this study
Official title: 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.
Read the 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
- Being tested
- ULF SCS
- Keywords
- Neuromodulation, Spinal Cord Stimulation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ULF SCSDevice
Ultra low frequency spinal cord stimulation
| Study group | Role | What they receive |
|---|---|---|
| ULF SCS | Experimental | 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. Receives: Device: ULF SCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (18)
Change in back pain VAS at 3 months
The mean percentage change in VAS back pain intensity from baseline.
Measured: 3 months
Change in back pain VAS at 6 months
The mean percentage change in VAS back pain intensity from baseline.
Measured: 6 months
Change in back pain VAS at 12 months
The mean percentage change in VAS back pain intensity from baseline.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Change in EQ-5D quality of life index at 6 months
The mean change in EQ-5D index from baseline.
Measured: 6 months
Change in EQ-5D quality of life index at 12 months
The mean change in EQ-5D index from baseline.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Change in sleep quality as assessed by MOS-SS at 6 months
The mean change in MOS-SS index from baseline.
Measured: 6 months
Change in sleep quality as assessed by MOS-SS at 12 months
The mean change in MOS-SS index from baseline.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start9 May 2023
- Primary completion19 May 2025
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Presidio Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Willem Volschenk, MBCHB, Principal investigator, Genesis Research ServicesMattew Green, BMBS, Principal investigator, CerCarePaul Verrills, MBBS, Principal investigator, Monash House Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837234
- Sponsor's protocol ID
- PMH-003
- Status last verified
- Aug 2025
- First submitted
- 19 Apr 2023
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05837234
- Acronym / sponsor ID
- PMH-003
- Conditions
- Chronic Pain, Chronic Low-back Pain
- Keywords
- Neuromodulation, Spinal Cord Stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Presidio Medical, IncIndustry (pharma, biotech, devices)
- Study start
- 9 May 2023 (actual)
- Primary completion
- 19 May 2025 (actual)
- Study completion
- Mar 2028 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ULF SCS | Experimental | Device: ULF SCSParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Be on no or stable pain medications, as determined by the investigator, for at least 28 days prior to the screening visit.
- Is currently considered medically stable as judged by investigator.
- Able to operate the SCS device (e.g., using remote control) and charge the device appropriately.
- Determined to be a good surgical candidate by the investigator.
Key exclusion criteria (7 listed)
- 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.
- 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.
- Previous experience with implantable neuromodulation devices (e.g., spinal cord stimulation, peripheral nerve stimulation, dorsal root ganglion stimulation).
- Opioid usage with average total daily morphine equivalent dose (MED) of >60 mg.
- A known need for an MRI or surgery within a 2-week period of the screening visit through the end of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ULF SCSUltra low frequency spinal cord stimulation | Device | ULF SCS |
Primary outcome
Back pain responder rate at 3 months as assessed using a visual analog scale (VAS)
Time frame: 3 months
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.
18 secondary outcomes
Change in back pain VAS at 3 months
Time frame: 3 months
Change in back pain VAS at 6 months
Time frame: 6 months
Change in back pain VAS at 12 months
Time frame: 12 months
Change in leg pain VAS at 3 months
Time frame: 3 months
Change in leg pain VAS at 6 months
Time frame: 6 months
Change in leg pain VAS at 12 months
Time frame: 12 months
Proportion of participants with a minimal clinically important difference (MCID) as measured by Oswestry Disability Index (ODI) at 3 months
Time frame: 3 months
Proportion of participants with a MCID as measured by ODI at 6 months
Time frame: 6 months
Proportion of participants with a MCID as measured by ODI at 12 months
Time frame: 12 months
Change in EuroQol-5 Dimension (EQ-5D) quality of life index at 3 months
Time frame: 3 months
Change in EQ-5D quality of life index at 6 months
Time frame: 6 months
Change in EQ-5D quality of life index at 12 months
Time frame: 12 months
Proportion of participants with remission of low back pain as assessed by VAS at 6 months
Time frame: 6 months
Proportion of participants with remission of low back pain as assessed by VAS at 9 months
Time frame: 9 months
Proportion of participants with remission of low back pain as assessed by VAS at 12 months
Time frame: 12 months
Change in sleep quality as assessed by Medical Outcomes Study Sleep Scale (MOS-SS) at 3 months
Time frame: 3 months
Change in sleep quality as assessed by MOS-SS at 6 months
Time frame: 6 months
Change in sleep quality as assessed by MOS-SS at 12 months
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Willem Volschenk, MBCHB principal investigator
Genesis Research Services
Mattew Green, BMBS principal investigator
CerCare
Paul Verrills, MBBS principal investigator
Monash House Research Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ULF SCS in people with Chronic Pain and Chronic Low-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 10 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 29 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Back pain responder rate at 3 months as assessed using a visual analog scale (VAS) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2025.