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Device
Spinal Cord Stimulation for Chronic Lower Back Pain
N/A
Recruiting
Led By Daniel C Lu, MD, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study how spinal cord stimulators impact functional measures in patients with chronic low back pain. Spinal cord stimulators have shown promise in reducing the need for drugs to manage pain. The
Who is the study for?
This trial is for individuals with chronic low back pain who haven't found relief through long-term medication. It's designed to see if spinal cord stimulators can help reduce pain without the need for drugs, potentially lowering opioid use.
What is being tested?
The study tests how an epidural electrical spinal cord stimulator affects people with chronic lower back pain. Researchers will look at changes in brain function, nerve activity, walking patterns, and self-reported pain levels.
What are the potential side effects?
Spinal cord stimulation may cause discomfort at the implant site, unwanted tingling or pricking sensations, infection risk from surgery, and potential equipment malfunction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Detection of brain connectivity using functional MRI
Secondary study objectives
Detection of brain waves using electroencephalography (EEG)
Other study objectives
Neurological gait kinematics assessment
Neurophysiological functional assessment using pain-related evoked potential (PREP)
Neurophysiological functional assessment using somatosensory evoked potential (SSEP)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Responders to spinal cord stimulationExperimental Treatment1 Intervention
Patients with chronic low back pain, with \>50% pain reduction in response to spinal cord stimulation
Group II: Non-responders to spinal cord stimulationExperimental Treatment1 Intervention
Patients with chronic low back pain, with minimal to no pain reduction in response to spinal cord stimulation
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Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,565 Previous Clinical Trials
10,263,169 Total Patients Enrolled
Daniel C Lu, MD, PhDPrincipal InvestigatorUniversity of California, Los Angeles
3 Previous Clinical Trials
98 Total Patients Enrolled
Lily Chau, MD, PhDStudy DirectorUniversity of California, Los Angeles
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