Clinical trial NCT05265000: Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain
Official title: Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: non-invasive, spinal cord stimulation, neuromodulation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Science Foundation Center for Disruptive Musculoskeletal Innovations
First posted: 2022-03-03
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Visual Analogue Scale (VAS) score
timeFrame: 3 hours
measure: Max Sagittal Vertical Axis
timeFrame: 3 hours
measure: L5S1/Torso Max Flex/Ext angle
timeFrame: 3 hours
measure: L5S1/Torso Max velocity
timeFrame: 3 hours
measure: Hip/Pelvis Max Flex/Ext angle
timeFrame: 3 hours
measure: Hip/Pelvis Max velocity
timeFrame: 3 hours
measure: Thing/Knee Max Flex/Ext angle
timeFrame: 3 hours
measure: Thing/Knee Max Velocity
timeFrame: 3 hours
measure: Insula - Cingulate connectivity
timeFrame: 3 hours
measure: Default Mode Network connectivity
timeFrame: 3 hours
measure: Erector Spinae activation (Root Mean Square)
timeFrame: 3 hours
measure: Rectus Femoris activation (Root Mean Square)
timeFrame: 3 hours
Secondary outcomes:
measure: Shank/Ankle Max Flex/Ext angle
timeFrame: 3 hours
measure: Shank/Ankle Max velocity
timeFrame: 3 hours
measure: Erector Spinae activation (Root Mean Square)
timeFrame: 3 hours
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Anastasia Keller, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Jeannie Bailey, PhD
role: PRINCIPAL_INVESTIGATOR
References: