Spinal Cord Stimulation for Chronic Lower Back Pain

Overseen By Jeannie F Bailey, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Bmi > 28, Spine hardware, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3 hours

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new, non-invasive treatment for chronic lower back pain using transcutaneous spinal cord stimulation (tSCS). Chronic lower back pain is a major issue worldwide, and this method aims to relieve pain without surgery. The trial will assess how well tSCS reduces pain and improves movements like standing and sitting. Ideal participants are those with persistent lower back pain who can get in and out of a chair without assistance and have not recently changed their medication. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new pain relief options.

Will I have to stop taking my current medications?

The trial requires that your medication dose remains stable for at least 2 weeks before joining. If you need to change your medications, you must do so before this 2-week period.

What prior data suggests that transcutaneous spinal cord stimulation is safe for chronic lower back pain?

Research has shown that transcutaneous spinal cord stimulation (tSCS) is generally well-tolerated. In earlier studies, participants experienced less pain and improved movement with only a few side effects. One study found that tSCS could aid movement recovery, indicating its safety for various conditions. Additionally, tSCS is non-invasive, meaning it doesn't involve surgery, which reduces the risk of complications associated with surgical procedures. While minor side effects, such as skin irritation at the device site, may occur, they are usually manageable. Overall, evidence suggests that tSCS is a safe option for those considering this treatment for chronic low back pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcutaneous Spinal Cord Stimulation (tSpinalStim) is unique because it offers a non-invasive approach to managing chronic lower back pain. Unlike traditional options like medication or surgery, which can have significant side effects or require lengthy recovery, tSpinalStim uses electrical stimulation to modulate nerve activity directly through the skin. This method can target pain pathways without the need for surgical implantation, making it a potentially safer and more accessible option. Researchers are excited because this technique could provide effective pain relief with fewer risks and quicker recovery times than current treatments.

What evidence suggests that transcutaneous spinal cord stimulation is effective for chronic lower back pain?

Research has shown that spinal cord stimulation (SCS) can effectively treat chronic low back pain (cLBP). In past studies, over 70% of patients experienced more than 50% pain relief after one year of using SCS. This trial will provide participants with Transcutaneous Spinal Cord Stimulation (tSCS), a non-invasive option that might offer similar benefits. By activating the same nerve pathways as traditional SCS, tSCS has shown promising results in reducing pain and improving movement. Since tSCS doesn't involve surgery, it might be more accessible and carry fewer risks. Overall, tSCS has the potential to be a powerful tool for managing chronic low back pain. ^{1 2 3 6 7}

Who Is on the Research Team?

Anastasia Keller, PhD

Principal Investigator

University of California, San Francisco

Jeannie Bailey, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

No changes in medication within 2 weeks of study enrollment

I have low back pain.

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

Exclusion Criteria

Changes in medications within 2 weeks of study enrollment

You have had a procedure involving epidural stimulation leads.

I experience muscle pain not related to my spine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcutaneous spinal cord stimulation (tSCS) to assess its feasibility in improving pain scores and objective measures such as sit-to-stand biomechanics, neurophysiological, and neuroimaging outcomes.

3 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Spinal Cord Stimulation

Trial Overview 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.

How Is the Trial Designed?

Group I: tSpinalStim Experimental Treatment 1 Intervention

Individuals in this arm will receive spinal cord stimulation

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Science Foundation Center for Disruptive Musculoskeletal Innovations

Collaborator

Trials

1

Recruited

50+

Published Research Related to This Trial

In a global study involving 1881 participants, spinal cord stimulation (SCS) demonstrated a high level of safety, with a low annualized device explant rate of 3.5% and only 1.1% due to inadequate pain relief.

The most common serious adverse event was implant site infection, occurring in less than 1% of cases, indicating that SCS is generally safe for chronic pain management over a follow-up period of up to 3 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. Rauck, RL., Loudermilk, E., Thomson, SJ., et al.[2023]

Transcutaneous spinal Direct Current Stimulation (tsDCS) can effectively modulate interhemispheric motor connectivity, with anodal stimulation increasing interhemispheric delay and decreasing the duration of the ipsilateral Silent Period, indicating enhanced communication between brain hemispheres.

The study suggests that tsDCS could serve as a promising therapeutic tool for conditions involving impaired interhemispheric balance, offering a safe alternative for rehabilitation in patients with acute brain lesions when other non-invasive brain stimulation techniques may not be suitable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An unexpected target of spinal direct current stimulation: Interhemispheric connectivity in humans. Bocci, T., Caleo, M., Vannini, B., et al.[2022]

In a clinical trial involving 83 patients with chronic back pain, 88% reported significant pain relief after using a high-frequency spinal cord stimulation (SCS) system, with back pain scores dropping from an average of 8.4 to 2.7 after six months.

The high-frequency SCS system not only provided substantial pain relief without causing the tingling sensation (paresthesia) typical of traditional SCS but also improved patients' disability and sleep quality, confirming its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-frequency spinal cord stimulation for the treatment of chronic back pain patients: results of a prospective multicenter European clinical study. Van Buyten, JP., Al-Kaisy, A., Smet, I., et al.[2022]

Noninvasive transcutaneous spinal cord stimulation (tSCS) has been shown to effectively induce muscle activation in individuals with spinal cord injury, based on a systematic review of 13 studies involving 55 participants.

While tSCS appears to enhance voluntary movement, muscle strength, and function, further research is needed to determine the optimal electrode placement and current intensity for maximum efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. Megía García, A., Serrano-Muñoz, D., Taylor, J., et al.[2021]

In a study involving 128 patients with chronic low back pain (LBP) and leg pain, Differential Target Multiplexed spinal cord stimulation (DTM SCS) showed a significantly higher responder rate of 80.1% compared to 51.2% for traditional SCS after 3 months, indicating its superior efficacy.

The mean reduction in LBP was also greater with DTM SCS (5.36 cm) than with traditional SCS (3.37 cm), and these improvements were maintained over a 12-month follow-up, with similar safety profiles for both treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twelve-Month results from multicenter, open-label, randomized controlled clinical trial comparing differential target multiplexed spinal cord stimulation and traditional spinal cord stimulation in subjects with chronic intractable back pain and leg pain. Fishman, M., Cordner, H., Justiz, R., et al.[2022]

Transcutaneous spinal cord stimulation (tSCS) shows potential for generating motor activity in individuals with spinal cord injury, but the overall quality of the studies reviewed was poor-to-fair, indicating a need for more rigorous research.

The review identified significant variability in stimulation parameters and outcome measurements across the 25 studies analyzed, highlighting the necessity for standardized methods to improve the reliability and comparability of tSCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. Taylor, C., McHugh, C., Mockler, D., et al.[2022]

Cervical transcutaneous spinal cord stimulation (tSCS) can effectively activate sensory fibers at lower stimulation intensities when the cathode electrode is positioned at the C7 or T1 vertebra, compared to C6, which may enhance rehabilitation outcomes for upper-limb motor recovery after spinal cord injury.

Using smaller electrode sizes not only lowers the activation threshold for sensory fibers but also optimizes the recruitment of these fibers before α-motor fibers, suggesting a strategic approach to improve hand muscle activation during tSCS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. de Freitas, RM., Capogrosso, M., Nomura, T., et al.[2022]

In a pilot study involving 7 individuals with chronic spinal cord injury, the use of transcutaneous electrical spinal cord stimulation (TSCS) combined with functional training led to improvements in upper and lower extremity function, with all participants showing progress on the Capabilities of Upper Extremity Test (CUE-T).

Notably, two participants improved their ASIA impairment scale classification, and five individuals experienced enhanced sensation, demonstrating that TSCS can facilitate recovery even after a plateau in rehabilitation progress, without any serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. Tefertiller, C., Rozwod, M., VandeGriend, E., et al.[2022]

Anodal transcutaneous spinal direct current stimulation (tsDCS) significantly increased the temporal summation threshold of the nociceptive withdrawal reflex in 10 healthy subjects, indicating its potential to modulate spinal cord pain pathways.

This stimulation also led to a decrease in the perception of pain, suggesting that anodal tsDCS could be an effective non-invasive treatment for clinical pain conditions related to spinal cord activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of temporal summation threshold of the nociceptive withdrawal reflex by transcutaneous spinal direct current stimulation in humans. Perrotta, A., Bolla, M., Anastasio, MG., et al.[2017]

In a pilot study involving 20 patients with idiopathic Restless Legs Syndrome (RLS) and 14 healthy subjects, transcutaneous spinal direct current stimulation (tsDCS) was shown to reduce symptoms of RLS, indicating its potential as a non-invasive treatment option.

Anodal stimulation specifically decreased spinal excitability, as measured by the H2/H1-ratio, and led to significant reductions in RLS symptoms, while sham stimulation had no effect, supporting the idea that spinal cord hyperexcitability contributes to RLS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous spinal direct current stimulation in idiopathic restless legs patients. Heide, AC., Winkler, T., Helms, HJ., et al.[2018]

Transcutaneous spinal cord stimulation (tSCS) can non-invasively enhance sensorimotor rehabilitation by modulating spinal cord circuitry, showing promise for improving recovery after spinal cord injuries.

Single-site tSCS can influence excitability across multiple spinal cord segments, while multi-site tSCS can enhance spinal reflexes and corticospinal networks, indicating its potential for more effective rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural Substrates of Transcutaneous Spinal Cord Stimulation: Neuromodulation across Multiple Segments of the Spinal Cord. Barss, TS., Parhizi, B., Porter, J., et al.[2022]

Citations

1. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05265000

Transcutaneous Spinal Cord Stimulation for Chronic Low ... In this pilot study we will establish the feasibility of tSCS to acutely improve patient reported outcomes (pain scores) and several objective measures.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12548825/

Protocol for a Systematic Review and Meta-Analysis - PMC Transcutaneous spinal cord stimulation (tSCS) has emerged as a promising neuromodulation technique for enhancing motor recovery and walking ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2826172

Spinal Cord Stimulation vs Medical Management for ... Specifically, patients treated with SCS therapies were more likely to achieve at least 50% pain reduction in either back or leg when measured at ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772594425000962

A systematic review of evidence comparing spinal cord ... Mean improvements in VAS for SCS patients at 6 months were 48% in leg pain and 26% in back pain, compared with −15% and 9%, respectively, for CMM patients. Mean ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12321793/

The effectiveness of spinal cord stimulation combined with ... Spinal cord stimulation alone led to significant pain reductions, with responder rates above 80% and average decreases of 5–6 cm on pain scales.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925000078

Safety and Effectiveness of Multisite Transcutaneous ... Combined tSCS + ABT facilitated functional recovery after chronic SCI. Improvements required ≥60 tSCS-ABT sessions, with further exposure to tSCS facilitating ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK553154/

Spinal Cord Stimulation - StatPearls - NCBI Bookshelf - NIH This technique uses pulsed electrical energy near the spinal cord to manage pain. This activity reviews the indications, contraindications, equipment, ...