Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain

Recruiting now · Not applicable

Conditions studied: Chronic Low-back Pain

In brief

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.

Key facts

Study ID

NCT05265000

Run by

University of California, San Francisco

People needed

50

Starts

2022-08-01

Expected to finish

2026-12-31

Last updated by the study team

2026-03-06

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• San Francisco VA Medical Center — San Francisco, California, United States (enrolling)

Full record on ClinicalTrials.gov

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