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NCT05265000 · ClinicalTrials.gov registry record · NA
Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain
A NA study of Chronic Low Back Pain, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05265000: Recruiting NA study of Chronic Low Back Pain, sponsored by University of California, San Francisco.
NCT05265000 is a NA study of Chronic Low Back Pain that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 50 participants, below the 591-participant average among 71 other Chronic Low Back Pain trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05265000, a NA study of Chronic Low Back Pain, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DEVICE tSpinalStim
Study Locations (1)
California
- San Francisco VA Medical Center - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What NCT05265000 shows while recruiting
NCT05265000 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 591-participant average among 71 other Chronic Low Back Pain trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Chronic Low Back Pain appearing as the primary indexed condition, and to 1 intervention - of which tSpinalStim is the first listed.
NCT05265000 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05265000 about?
NCT05265000 is a clinical study titled "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....
What is the current status of trial NCT05265000?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2022-08-01. Estimated completion is 2026-12-31.
What conditions does trial NCT05265000 study?
This clinical trial studies the following conditions: Chronic Low Back Pain.
What interventions are being tested in trial NCT05265000?
The interventions under investigation include: tSpinalStim (DEVICE).
Who is sponsoring clinical trial NCT05265000?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05265000 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Low Back Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05265000's enrollment target sits among peer trials
50 44th of 71 higher than 26 of 71 other Chronic Low Back Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Low Back Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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