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Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain

University of California, San Francisco · with National Science Foundation Center for Disruptive Musculoskeletal Innovations · NCT05265000

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 21–85 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
50
US sites recruiting
1
Study start
August 1, 2022
Record last updated
March 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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 complications associated with surgical intervention still occur.Transcutaneous spinal cord stimulation (tSCS) is a rapidly developing non invasive neuromodulation technique in the field of spinal cord injury. Its application potentiates lumbosacral spinal cord excitability enabling motor functions, (e.g. independent standing, postural control) in patients with chronic complete motor paralysis. Given that epidural and transcutaneous SCS activate similar neuronal networks, tSCS for cLBP treatment may be advantageous due to its non-invasive nature which may also allow for a mass market production and rapid patient availability if tSCS is proven efficacious. In this pilot study we will establish the feasibility of tSCS to acutely improve patient reported outcomes (pain scores) and several objective measures, including sit-to-stand biomechanics, neurophysiological and neuroimaging outcomes.

Being studied: tSpinalStim

Conditions: Chronic Low-back Pain

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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)

Recruiting US locations

  • San Francisco VA Medical Center

    San Francisco, CA 94121

    Site contact: Anastasia Keller, PhD · anastasia.keller@ucsf.edu

Study contacts (from the official record)

  • Anastasia Keller · 628-206-3734 · anastasia.keller@ucsf.edu
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Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain (NCT05265000) | Bored Studies