Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain

NARecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

August 1, 2022

Primary Completion Date

June 1, 2026

Study Completion Date

June 1, 2026

Conditions
Chronic Low-back Pain
Interventions
DEVICE

tSpinalStim

Patients will undergo 12-21 sessions of spinal cord stimulation therapy (30 minutes per session, 3 times a week). Up to five round stimulating electrodes will be placed on the skin midline between spinous processes in cervical, thoracic and/or lumbar region, as cathodes and rectangular pads will be placed symmetrically on the skin over the iliac crests as anodes. The stimulator generates pain-free biphasic rectangular waveform with 1 ms width pulses filled with 5-10 kHz (kilohertz) carrier frequency. A range of stimulation intensities from 0-250 mA (milliamps) may be used. We expect that the stimulation intensities needed for therapeutic effect may differ based on individual's body mass index and/or the amount of subcutaneous fat present at the stimulation site.

Trial Locations (1)

94121

RECRUITING

San Francisco VA Medical Center, San Francisco

All Listed Sponsors
collaborator

National Science Foundation Center for Disruptive Musculoskeletal Innovations

UNKNOWN

lead

University of California, San Francisco

OTHER