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NCT Number: NCT05265000

Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain

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.

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Key information

Conditions

Chronic Low-back Pain

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location status: Recruiting

Location contact

Anastasia Keller, PhD

CONTACT

[email protected]

Anastasia V Keller, PhD

PRINCIPAL_INVESTIGATOR

Jeannie F Bailey, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

tSpinalStim

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.

Other names: Transcutaneous spinal cord stimulation

Primary outcomes

  1. Visual Analogue Scale (VAS) score

    Time frame: 3 hours

    A patient reported outcome of pain; will be assessed by presenting a VAS tool with the scale of 0 -10, 0 - being no pain and 10 the worst pain imaginable. VAS scores will be collected before and after the intervention

  2. Max Sagittal Vertical Axis

    Time frame: 3 hours

    A kinematic variable that measures body flexion (degrees) relative to the vertical sagittal axis (virtual straight line through the midline of the body) assessed using Kinect-2 depth camera while subject performs 3-5 trials of sit-to-stand movement

  3. L5S1/Torso Max Flex/Ext angle

    Time frame: 3 hours

    A kinematic variable that measures torso/L5S1 joint flexion and extension (degrees) assessed using Kinect-2 depth camera while subject performs 3-5 trials of sit-to-stand movement. The maximum flexion and extension will be compared between baseline and post-intervention.

  4. L5S1/Torso Max velocity

    Time frame: 3 hours

    A kinetic variable that measures torso/L5S1 velocity (m/s) assessed using Kinect-2 depth camera while subject performs 3-5 trials of sit-to-stand movement. The maximum velocities will be compared between baseline and post-intervention.

  5. Hip/Pelvis Max Flex/Ext angle

    Time frame: 3 hours

    A kinematic variable that measures pelvis/hip joint flexion and extension (degrees) assessed using Kinect-2 depth camera while subject performs 3-5 trials of sit-to-stand movement The maximum flexion and extension will be compared between baseline and post-intervention.

  6. Hip/Pelvis Max velocity

    Time frame: 3 hours

    A kinematic variable that measures pelvis/hip joint velocity (m/s) assessed using Kinect-2 depth camera while subject performs 3-5 trials of sit-to-stand movement The maximum velocity will be compared between baseline and post-intervention.

  7. Thing/Knee Max Flex/Ext angle

    Time frame: 3 hours

    A kinetic variable that measures thigh/knee joint flexion and extension (degrees) assessed using Kinect-2 depth camera while subject performs 3-5 trials of sit-to-stand movement The maximum flexion and extension will be compared between baseline and post-intervention.

  8. Thing/Knee Max Velocity

    Time frame: 3 hours

    A kinetic variable that measures thigh/knee joint velocity (m/s) assessed using Kinect-2 depth camera while subject performs 3-5 trials of sit-to-stand movement The maximum flexion and extension will be compared between baseline and post-intervention.

  9. Insula - Cingulate connectivity

    Time frame: 3 hours

    A neuroimaging outcome variable that measures functional connectivity (Fisher z-scores, Fz) between the Insula - and Cingulate brain regions. Patients will undergo brain functional magnetic resonance imaging (fMRI) scan before and after intervention. Fz scores will be compared between baseline and post-intervention

  10. Default Mode Network connectivity

    Time frame: 3 hours

    A neuroimaging outcome variable that measures functional connectivity (Fisher-z scores, Fz) of the brain default mode network. Patients will undergo brain functional magnetic resonance imaging (fMRI) fMRI scan before and after intervention. Fz scores will be compared between baseline and post-intervention

  11. Erector Spinae activation (Root Mean Square)

    Time frame: 3 hours

    Erector Spinae (ES) activation will be measured using surface electromyography (EMG) recorded with bilateral EMG electrodes placed at L5 levels while patient performs 3-5 trials of sit-to-stand (concomitant with biomechanics assessment). The root mean square will be calculated during the time period it take the patient to completed sit-to-stand transition (from lift off from the chair to standing)

  12. Rectus Femoris activation (Root Mean Square)

    Time frame: 3 hours

    Rectus femoris (ES) activation will be measured using surface electromyography (EMG) recorded with bilateral EMG electrodes placed on top of the muscle belly at mid thigh while patient performs 3-5 trials of sit-to-stand (concomitant with biomechanics assessment). The root mean square will be calculated during the time period it take the patient to completed sit-to-stand transition (from lift off from the chair to standing)

Secondary outcomes

  1. Shank/Ankle Max Flex/Ext angle

    Time frame: 3 hours

    A kinematic variable that measures shank/ankle joint flexion and extension (degrees) assessed using Kinect-2 depth camera while subject performs 3-5 trials of sit-to-stand movement The maximum flexion and extension will be compared between baseline and post-intervention.

  2. Shank/Ankle Max velocity

    Time frame: 3 hours

    A kinetic variable that measures shank/ankle joint velocity (m/s) assessed using Kinect-2 depth camera while subject performs 3-5 trials of sit-to-stand movement The maximum velocity will be compared between baseline and post-intervention.

  3. Erector Spinae activation (Root Mean Square)

    Time frame: 3 hours

    Erector Spinae (ES) activation will be measured using surface electromyography (EMG) recorded with bilateral EMG electrodes placed at T10 levels while patient performs 3-5 trials of sit-to-stand (concomitant with biomechanics assessment). The root mean square will be calculated during the time period it take the patient to completed sit-to-stand transition (from lift off from the chair to standing)

Study contacts

Contact information is provided by the study sponsor or research team.

Anastasia Keller

CONTACT

[email protected]

628-206-3734

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Science Foundation Center for Disruptive Musculoskeletal Innovations

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2022
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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