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New treatment option for Nociceptive Pain
Official title Ultra Low Frequency Neuromodulation for Nociceptive Chronic Low Back Pain
ClinicalTrials.gov ID: NCT06763653
What this study is testing
- What it's testing
- 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.
- Time commitment: about 24 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join 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 treatment therapies.
- Back pain greater than leg pain.
- ODI score ≥30 and ≤80.
- On stable pain medications or on no pain medications.
You likely can't join 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...
- Presence of spinal stenosis, structural spinal abnormality, or spinal instrumentation observed on MRI or CT that would make lead placement unsafe or...
- Previous experience with neuromodulation devices for pain.
- Opioid usage with average total daily morphine equivalent dose (MED) of \>100 mg.
See the full eligibility criteria
- 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 treatment 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.
- 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...
- 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 treatment clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Norwood, South Australia, Australia
- Wayville, South Australia, Australia
- Clayton, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Norwood, South Australia, Australia; Wayville, South Australia, Australia; Clayton, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.