What is the mechanism of action of this treatment?

Transcutaneous spinal cord stimulation (tSCS) is a non-invasive neuromodulation technique that activates spinal neuronal networks to alleviate chronic lower back pain (cLBP). By delivering electrical currents through the skin, tSCS enhances the excitability of the lumbosacral spinal cord, which can modulate pain signals and improve motor functions. This method is advantageous for cLBP patients as it avoids the risks associated with surgical implantation of devices, offering a safer and potentially more accessible treatment option. The activation of spinal networks through tSCS can lead to significant pain relief and functional improvements, making it a promising alternative for those suffering from chronic pain.

What side effects are associated with this type of intervention?

Common treatments for chronic lower back pain using non-invasive neuromodulation techniques, such as transcutaneous spinal cord stimulation (tSCS) and transcutaneous electrical nerve stimulation (TENS), generally have mild side effects. These can include sensations of warmth, tingling, or numbness at the site of stimulation. Some patients may experience muscle spasms, redness, itching, or mild pain in the treated area. Serious adverse events are rare, making these treatments relatively safe options for managing chronic lower back pain.

What prior FDA approvals exist?

The FDA has approved several neuromodulation devices for the treatment of chronic lower back pain, including Spinal Cord Stimulation (SCS) systems. Traditional SCS involves the surgical implantation of epidural electrodes to deliver electrical pulses that inhibit pain signals. These devices have shown significant efficacy, with over 70% of patients experiencing more than 50% pain relief after one year of treatment. While tSCS is a non-invasive alternative currently under investigation, it aims to activate similar neuronal networks without the need for surgical implantation, potentially offering a safer and more accessible option for patients with cLBP.

What other types of research exist?

Promising, novel alternatives to Transcutaneous Spinal Cord Stimulation (tSCS) for chronic lower back pain include: 1) Transcutaneous Electrical Nerve Stimulation (TENS), which has been shown to reduce pain and improve function in various chronic pain conditions. 2) Spinal Cord Stimulation (SCS) with implantable devices, which has demonstrated significant pain relief in clinical trials, though it is less non-invasive. 3) Sacral Nerve Stimulation, which is being explored for its potential to modulate pain pathways and improve symptoms. These alternatives offer different mechanisms and potential benefits for managing chronic lower back pain.

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Procedure

Spinal Cord Stimulation for Chronic Lower Back Pain

N/A

Recruiting

Led By Jeannie Bailey, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to get in and out of chair unassisted

Be older than 18 years old

Must not have

Presence of any additional neuromuscular pain unrelated to spinal condition

Moderate/severe depression (Beck Depression Inventory score > 20)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new method called transcutaneous spinal cord stimulation (tSCS) for people with chronic low back pain. tSCS uses electrical currents applied through the skin to help reduce pain. The goal is to see if this non-invasive treatment can improve pain and movement without the need for surgery.

Who is the study for?

This trial is for individuals with chronic lower back pain who can get in and out of a chair on their own. They shouldn't have had any medication changes or started new ones within two weeks before joining the study. People with a BMI over 28, spinal hardware from past surgeries, epidural stimulation leads, other neuromuscular pain conditions, intolerance to electrical stimulation, or moderate/severe depression are excluded.

What is being tested?

The trial is testing tSpinalStim (transcutaneous spinal cord stimulation) as a non-invasive treatment for chronic low back pain. It aims to see if this method can improve patient-reported outcomes like pain scores and objective measures such as sit-to-stand biomechanics without requiring surgical implantation.

What are the potential side effects?

Potential side effects may include discomfort at the site of stimulation or skin irritation due to the transcutaneous device's electrodes. Since it's non-invasive, there are fewer risks compared to surgically implanted devices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can get in and out of a chair without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I experience muscle pain not related to my spine.

Select...

I have moderate to severe depression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Default Mode Network connectivity

Hip/Pelvis Max Flex/Ext angle

Hip/Pelvis Max velocity

+8 more

Secondary study objectives

Erector Spinae activation (Root Mean Square)

Shank/Ankle Max Flex/Ext angle

Shank/Ankle Max velocity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: tSpinalStimExperimental Treatment1 Intervention

Individuals in this arm will receive spinal cord stimulation

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Transcutaneous spinal cord stimulation (tSCS) is a non-invasive neuromodulation technique that activates spinal neuronal networks to alleviate chronic lower back pain (cLBP). By delivering electrical currents through the skin, tSCS enhances the excitability of the lumbosacral spinal cord, which can modulate pain signals and improve motor functions. This method is advantageous for cLBP patients as it avoids the risks associated with surgical implantation of devices, offering a safer and potentially more accessible treatment option. The activation of spinal networks through tSCS can lead to significant pain relief and functional improvements, making it a promising alternative for those suffering from chronic pain.

Transcutaneous spinal cord stimulation of the cervical cord modulates lumbar networks.