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New treatment option for Chronic Low Back Pain
Official title Phenotyping Response to Spinal Cord Stimulation in Chronic Low Back Pain
ClinicalTrials.gov ID: NCT06310226
What this study is testing
- What it's testing
- Chronic low back pain (CLBP) is a debilitating condition and costly to treat. Long-term drug treatment often fails due to habituation, breakthrough of pain, or adverse effects of drug treatment.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Able to give informed consent for participation in the trial and be able to comply with study-related requirements, procedures, and visits
- Male or female, between the ages of 18 and 80 years (inclusive)
- Current self-report of chronic low back pain (pain between the lower posterior margin of the rib cage and the horizontal gluteal fold), which has...
- Already undergoing spinal cord stimulator treatment for chronic low back pain
- Able to use their lower extremities
You likely can't join if
- Significant decision-making incapacity preventing informed consent
- Any medical condition that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as...
- Lifetime history of psychiatric disorder (schizophrenia, bipolar disorder with psychotic features, or other psychotic disorder), or current suicidal...
- Any stimulation device and/or implant other than a spinal cord stimulator, such as a drug pump, pacemaker, deep brain stimulator (DBS), or sacral...
- Life expectancy of less than 1 year
- Pregnant or nursing (if female and sexually active, patient must be using a reliable form of birth control, be surgically sterile, or be at least 2...
See the full eligibility criteria
- Able to give informed consent for participation in the trial and be able to comply with study-related requirements, procedures, and visits
- Male or female, between the ages of 18 and 80 years (inclusive)
- Current self-report of chronic low back pain (pain between the lower posterior margin of the rib cage and the horizontal gluteal fold), which has persisted for \> the past 3 months AND has resulted in pain on \> 50% of...
- Already undergoing spinal cord stimulator treatment for chronic low back pain
- Able to use their lower extremities
- Able to tolerate fMRI and neurophysiological evaluation
- Significant decision-making incapacity preventing informed consent
- Any medical condition that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator.
- Lifetime history of psychiatric disorder (schizophrenia, bipolar disorder with psychotic features, or other psychotic disorder), or current suicidal ideation
- Any stimulation device and/or implant other than a spinal cord stimulator, such as a drug pump, pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS)
- Life expectancy of less than 1 year
- Pregnant or nursing (if female and sexually active, patient must be using a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal)
- Any documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency (not including marijuana use)
- Participation in another clinical trial currently or within the past 30 days
- Current treatment with electroconvulsive therapy (ECT) or transcranial magnetic stimulation (rTMS)
- Conditions that preclude assessing brain function by fMRI: previous head injury, brain surgery, dementia, spinal cord injury, traumatic brain injury, cortical atrophy, serious neurological or medical illness...
- MRI compatibility: No major contraindication to MRI (e.g. claustrophobia, pacemaker, vascular stents, metallic ear tubes) and metal implants that would preclude use of MRI
- History of spine surgery with existing instrumentation failure (i.e., broken screws or rods) or pseudarthrosis (lack of fusion) that could be the cause of CLBP
- Any other comorbidity or condition that, in the opinion of the Investigator would make the subject unsuitable for the study or unable to comply with the study requirements
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. 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.