Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain
RecruitingNot applicableNCT05265000
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain
- Conditions
- Interventions
- Device: tSpinalStim
- Sponsor
- University of California, San Francisco
- Collaborators
- National Science Foundation Center for Disruptive Musculoskeletal Innovations
- Start date
- 2022-08-01
- Primary completion
- 2026-12-31
- Sex
- All
- Age range
- from 21 Years to 85 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05265000