Understanding how spinal cord stimulation affects chronic low back pain
Characterizing Functional MRI Phenotypes in Response to Spinal Cord Stimulation in Chronic Low Back Pain
NA · University of California, Los Angeles · NCT06310226
This study is testing how spinal cord stimulation can help people with chronic low back pain feel better and improve their daily activities.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles (other) |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06310226 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of spinal cord stimulation (SCS) on patients with chronic low back pain (CLBP) by examining various functional measures such as functional MRI, neurophysiology, gait analysis, and patient questionnaires. The goal is to identify the neurophysiological processes associated with pain and develop predictors for treatment response to SCS. By understanding these mechanisms, the study aims to improve the effectiveness of SCS and reduce reliance on opioid medications for pain management. This research addresses the challenges of unpredictable responses to SCS and seeks to establish a more reliable treatment approach for CLBP.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who have been experiencing chronic low back pain for over three months and are currently undergoing spinal cord stimulation treatment.
Not a fit: Patients with significant decision-making incapacity or medical conditions that interfere with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatments for chronic low back pain, reducing the need for opioid medications.
How similar studies have performed: While spinal cord stimulation has been used for decades, this study's approach to understanding the neurophysiological mechanisms is novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 days in the past 6 months\* (\*Chronic low back pain criteria as defined by the NIH Pain Consortium Research Task Force (RTF) and BACPAC Minimum Dataset Working Group) * Already undergoing spinal cord stimulator treatment for chronic low back pain * Able to use their lower extremities * Able to tolerate fMRI and neurophysiological evaluation Exclusion Criteria: * 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, psychiatric illness, development disability, sensory impairment such as vision and hearing loss, history of birth weight less than 2000 grams and/or gestational age less than 34 weeks) * 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
Where this trial is running
Los Angeles, California
- University of California, Los Angeles — Los Angeles, California, United States (RECRUITING)
Study contacts
- Principal investigator: Daniel C Lu, MD, PhD — University of California, Los Angeles
- Study coordinator: Lily Chau, MD, PhD
- Email: lilychau@mednet.ucla.edu
- Phone: 310-267-1770
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Low Back Pain