Non-invasive spinal cord stimulation for chronic low back pain relief
Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain
This study is testing a new way to relieve chronic low back pain using a non-invasive method that sends electrical signals to the spinal cord, helping people feel better without surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years to 85 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05265000 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of transcutaneous spinal cord stimulation (tSCS) as a non-invasive method to alleviate chronic low back pain (cLBP). The approach aims to provide pain relief without the need for surgical implantation of devices, which can carry risks of complications. By utilizing electrical stimulation on the spinal cord, the study seeks to evaluate the effectiveness of this method in reducing pain levels in patients suffering from cLBP. Participants will undergo assessments to determine the impact of tSCS on their pain management.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals experiencing chronic low back pain who can independently perform daily activities.
Not a fit: Patients with a Body Mass Index over 28 or those with prior spinal hardware or other neuromuscular pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a safer and effective alternative for managing chronic low back pain without the need for invasive procedures.
How similar studies have performed: Previous studies on spinal cord stimulation have shown promising results, indicating that this approach may be effective, although the specific non-invasive method being tested is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
San Francisco, California
- San Francisco VA Medical Center — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Anastasia Keller, PhD — University of California, San Francisco
- Study coordinator: Anastasia Keller
- Email: anastasia.keller@ucsf.edu
- Phone: 628-206-3734
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.