Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain

• ClinicalTrials.gov Identifier: NCT05265000
• Recruitment Status: Recruiting
• First Posted: March 3, 2022
• Last Update Posted: April 20, 2022
• Sponsor: University of California, San Francisco
• Collaborator: National Science Foundation Center for Disruptive Musculoskeletal Innovations
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Low-back Pain	Device: tSpinalStim; Device: sham_tSpinalStim	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain
• Estimated Study Start Date: June 1, 2022
• Estimated Primary Completion Date: September 1, 2022
• Estimated Study Completion Date: December 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: tSpinalStim; Individuals in this arm will receive spinal cord stimulation	Device: tSpinalStim; Transcutaneous spinal cord stimulation protocol (aim 1): Up to three round stimulating electrodes will be placed on the skin midline between spinous processes in cervical, thoracic and/or lumbar region, as cathodes and 2 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. Stimulation frequency will be set anywhere between 3- 100 Hz for all channels. 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. Sham stimulation: For sham-tSCS session, the electrodes will be placed at the same location. Stimulation will be first turned on and will be gradually decreased down to 0 mA in 1 min.; Other Name: Transcutaneous spinal cord stimulation
Sham Comparator: sham_tSpinalStim; Individuals in this arm will receive placebo or sham spinal cord stimualtion	Device: sham_tSpinalStim; Sham transcutaneous spinal cord stimulation

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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)

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Veronica Andaya; 415 502 6314; veronica.andaya@ucsf.edu

Locations

United States, California

San Francisco VA Medical Center; Recruiting

San Francisco, California, United States, 94121

Contact: Veronica Andaya 415-502-6314 veronica.andaya@ucsf.edu

Principal Investigator: Anastasia V Keller, PhD

Principal Investigator: Jeannie F Bailey, PhD

Sponsors and Collaborators

University of California, San Francisco

National Science Foundation Center for Disruptive Musculoskeletal Innovations

Investigators

• Principal Investigator: Anastasia Keller, PhD; University of California, San Francisco
• Principal Investigator: Jeannie Bailey, PhD; University of California, San Francisco

More Information

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT05265000
• Other Study ID Numbers: tSCS4LBP
• First Posted: March 3, 2022
• Last Update Posted: April 20, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Deidentified raw data will be deposited in a publically available data repository and/or can be made available per request to the principal investigators of the study
• Supporting Materials: Study Protocol; Clinical Study Report (CSR); Analytic Code
• Time Frame: The data will be available after all data has been collected and analyzed (approximately in the Spiring of 2023) and will be available indefinitely.
• Access Criteria: Anyone may send a request to the principal investigators for the deidentified participant data to be shared with them. Anyone who has access to the internet/data repositories may access the publicly deposited de-identified participant data.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of California, San Francisco:

non-invasive, spinal cord stimulation, neuromodulation

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations