Actively Recruiting
Ultra Low Frequency Neuromodulation for Nociceptive Chronic Low Back Pain
Led by Presidio Medical, Inc · Updated on 2025-01-24
303
Participants Needed
3
Research Sites
219 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Ultra Low Frequency Neuromodulation for Nociceptive Chronic Low Back Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 22 years or older
- Chronic, difficult-to-treat nociceptive axial low back pain for at least 3 months with back pain greater than leg pain
- Pain score of 6 cm or higher on a visual analog scale for back pain over 7 days
- Symptoms not adequately improved by physical therapy, medications, or interventional therapies
- Oswestry Disability Index (ODI) score between 30 and 80
- On stable pain medications or not taking pain medications
- Medically stable and suitable for surgery
- Able to operate the study device
- Willing to sign consent and comply with study visits
- Able to complete questionnaires independently
You will not qualify if you...
- Having an unstable systemic disease or condition
- Severe cognitive impairment preventing questionnaire completion or device use
- Active psychological or psychiatric disorder impacting pain perception or treatment compliance
- Spinal stenosis, structural abnormalities, or spinal hardware making device placement unsafe
- Previous use of neuromodulation devices for pain
- Using high-dose opioids (morphine equivalent dose over 100 mg per day)
- Untreated addiction to alcohol or drugs within 6 months
- Having a cardiac pacemaker, defibrillator, or other implanted electronic device
- Known allergy to materials used in the study device
- Need for MRI or surgery during the study period
- Pregnancy or planning pregnancy for women of childbearing potential
- Untreated malignant tumors or life expectancy less than 1 year
- Participation in another interventional clinical trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
The International Spine Centre
Norwood, South Australia, Australia, 5067
Actively Recruiting
2
CerCare Pty Ltd
Wayville, South Australia, Australia
Actively Recruiting
3
Monash House Research Centre
Clayton, Victoria, Australia, 3168
Actively Recruiting
Research Team
V
Valerie Cimmarusti
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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