Ultra Low Frequency Neuromodulation for Nociceptive Chronic Low Back Pain
NCT ID: NCT06763653
Last Updated: 2025-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
303 participants
INTERVENTIONAL
2025-01-17
2029-04-30
Brief Summary
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* 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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ULF therapy plus CMM
An implanted SCS device delivering ultra low frequency neuromodulation
ULF therapy
ultra low frequency spinal cord stimulation
CMM
conventional medical management
CMM alone
Conventional medical management
CMM
conventional medical management
Interventions
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ULF therapy
ultra low frequency spinal cord stimulation
CMM
conventional medical management
Eligibility Criteria
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Inclusion Criteria
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
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.
22 Years
ALL
No
Sponsors
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Presidio Medical, Inc
INDUSTRY
Responsible Party
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Locations
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The International Spine Centre
Norwood, South Australia, Australia
CerCare Pty Ltd
Wayville, South Australia, Australia
Monash House Research Centre
Clayton, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PMH-006
Identifier Type: -
Identifier Source: org_study_id
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