Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain

NCT ID: NCT05265000

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2026-06-01

Brief Summary

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.

Conditions

Chronic Low-back Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tSpinalStim

Individuals in this arm will receive spinal cord stimulation

Group Type: EXPERIMENTAL

tSpinalStim

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Transcutaneous spinal cord stimulation

Eligibility 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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Science Foundation Center for Disruptive Musculoskeletal Innovations

UNKNOWN

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anastasia Keller, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Jeannie Bailey, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

San Francisco VA Medical Center

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anastasia Keller

Role: CONTACT

anastasia.keller@ucsf.edu

628-206-3734

Facility Contacts

Anastasia Keller, PhD

Role: primary

anastasia.keller@ucsf.edu

Related Links

https://ucsf.co1.qualtrics.com/jfe/form/SV_0oYFlZbwWwOgOOy

If you are interested in participating in the study, please follow the link to the initial patient screening survey

Other Identifiers

tSCS4LBP

Identifier Type: -

Identifier Source: org_study_id