Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain

University of California San Francisco (UCSF)

Status

Enrolling

Conditions

Chronic Low-back Pain

Treatments

Device: tSpinalStim

Study type

Interventional

Funder types

Other

Identifiers

NCT05265000

tSCS4LBP

Details and patient eligibility

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.

Enrollment

50 estimated patients

Sex

All

Ages

21 to 85 years old

Volunteers

Accepts Healthy Volunteers

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)