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Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain

RecruitingNAAges 21 Years - 85 YearsAllUniversity of California, San Francisco
NCT05265000 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

As a leading cause of disability worldwide, chronic low back pain (cLBP) represents a significant medical and socioeconomic problem with estimated health care spending of $87 billion/annually. The efficacy of dorsal column electrical stimulation to inhibit pain was first described over 50 years ago. Since then, several large clinical trials have investigated the therapeutic potential of electrical spinal cord stimulation (SCS) and found that over 70% of patients with intractable pain had over 50% pain relief after 1 year of treatment. Thus, SCS is a promising therapeutic intervention that has superior patient outcomes when compared to traditional modalities for the treatment of cLBP. To date, SCS for treatment of cLBP has been delivered via epidural electrodes, requiring neurosurgical implantation. Although, the implantable stimulators have a low rate of adverse events, secondary complic

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📋 Eligibility rules (as published)
Inclusion Criteria: * Low back pain * Able to get in and out of chair unassisted * No changes in medication within 2 weeks of study enrollment * Stable dose of their medications within 2 weeks of study enrollment Exclusion Criteria: * Body Mass Index (BMI) \> 28 * Hardware in the spine from prior surgeries * Presence of epidural stimulation leads * Presence of any additional neuromuscular pain unrelated to spinal condition * Intolerance to any form of electrical stimulation, such as neuromuscular stimulation in the past * Lack of perceived endurance to go through multiple experimental assessments in one day/complete the study which may take up to 3 hours * Changes in medications within 2 weeks of study enrollment * Moderate/severe depression (Beck Depression Inventory score \> 20)
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What it tests

  • tSpinalStim
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Where

1 site
San Francisco VA Medical Center
San Francisco, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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