Spinal Cord Stimulation Techniques for Chronic Pain

Overseen By Vafi Salmasi, MD.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Motor weakness, Previous failed trial, others

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

Compensation: Varies

Number of Visits: 1

Duration: 36 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two types of spinal cord stimulation—high frequency and burst—can help individuals with chronic pain in the lower back or legs. The goal is to determine which type more effectively relieves pain and improves daily function. Individuals with persistent lower back or leg pain for over six months, who are suitable candidates for this treatment, may qualify. The trial aims to provide long-term data on the effectiveness of these treatments, aiding doctors in making better decisions for managing chronic pain. As an unphased trial, it offers patients the chance to contribute to valuable research that could enhance chronic pain management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these spinal cord stimulation techniques are safe for chronic pain patients?

Research shows that both burst and high-frequency spinal cord stimulation (SCS) are generally safe for treating chronic pain. Studies have found that most patients tolerate these treatments well over long periods.

For burst SCS, safety data from various studies suggest it is effective and safe, even for patients with significant psychological issues. No major evidence of severe side effects has been linked to burst SCS, making it a viable option for many.

High-frequency SCS also shows promising safety results. A review of studies found that this method helps manage chronic pain effectively with minimal risk. Long-term safety data indicate it is safe for most patients.

Overall, both burst and high-frequency SCS have been widely used and have shown good safety records. No significant evidence of major safety concerns exists, making these treatments promising options for those with chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about spinal cord stimulation techniques like burst and high frequency stimulation for chronic pain because they offer new ways to manage discomfort. Unlike traditional treatments, which often rely on medications or lower frequency stimulation, these methods use advanced waveforms to directly target the spinal cord. Burst stimulation mimics natural neural firing patterns, potentially providing more effective and longer-lasting pain relief. High frequency stimulation, on the other hand, operates at a higher rate to avoid uncomfortable tingling sensations commonly associated with standard spinal cord stimulators. These innovations could lead to better pain management outcomes for patients without the side effects of conventional treatments.

What evidence suggests that these spinal cord stimulation techniques are effective for chronic pain?

This trial will compare two spinal cord stimulation techniques for managing chronic pain: burst spinal cord stimulation and high-frequency spinal cord stimulation. Research has shown that spinal cord stimulation can effectively manage chronic pain, with about half of the patients experiencing more than 50% pain relief. Participants in this trial may receive burst spinal cord stimulation, which studies indicate reduces pain even in individuals with high levels of stress or anxiety, working as effectively for them as for those without such distress. Alternatively, participants may receive high-frequency spinal cord stimulation, which has proven to provide significant and lasting relief from back and leg pain. Patients also report better movement and improved sleep. Both methods show promise for managing chronic pain, with studies supporting their long-term effectiveness. ^{3 5 6 7 8}

Who Is on the Research Team?

Vafi Salmasi, MD.

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 with chronic lower back or leg pain lasting more than six months, who are recommended for spinal cord stimulation by Stanford's Pain Management Center. It excludes those who refuse to participate, have motor weakness in the lower body, or had a previous failed spinal cord stimulation trial.

Inclusion Criteria

I have had lower back or leg pain for over six months.

I am recommended for spinal cord stimulation based on a team's advice.

Exclusion Criteria

I have chosen not to participate in the trial.

I have tried spinal cord stimulation without success.

You have weakness in your lower body as determined by the doctors who are treating your pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either high frequency or burst spinal cord stimulation

36 months

Baseline and follow-up surveys at 1, 3, 6, 12, 18, 24, and 36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Burst spinal cord stimulation
• High frequency spinal cord stimulation

Trial Overview The study compares two types of spinal cord stimulations: high frequency and burst waveforms. It aims to determine which is more effective for long-term pain relief and function improvement in patients with chronic pain using an innovative data system called CHOIR.

How Is the Trial Designed?

Group I: High frequency spinal cord stimulation Experimental Treatment 1 Intervention

Implant of the device that can deliver high frequency waveform to spinal cord

Group II: Burst spinal cord stimulation Experimental Treatment 1 Intervention

Implant of the device that can deliver burst waveform to spinal cord

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

In a study of 48 chronic pain patients familiar with spinal cord stimulation (SCS), burst stimulation significantly reduced pain by an average of 44% in those with painful diabetic neuropathy and 28% in those with failed back surgery syndrome, compared to conventional tonic stimulation.

Burst stimulation was preferred by most patients because it caused little to no paresthesia, unlike tonic stimulation, which some patients preferred for the reassurance it provided that the SCS was working.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Burst spinal cord stimulation evaluated in patients with failed back surgery syndrome and painful diabetic neuropathy. de Vos, CC., Bom, MJ., Vanneste, S., et al.[2022]

A study involving 102 patients from Belgium and the Netherlands found that burst spinal cord stimulation significantly reduced pain more effectively than conventional tonic stimulation, with average pain scores dropping from 7.8 to 3.2 on a numeric rating scale.

Burst stimulation was able to convert 62.5% of patients who did not respond to tonic stimulation into responders, while also enhancing pain relief for those who already benefited from tonic stimulation, increasing their pain suppression from 50.6% to 73.6%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 2-center comparative study on tonic versus burst spinal cord stimulation: amount of responders and amount of pain suppression. De Ridder, D., Lenders, MW., De Vos, CC., et al.[2015]

Burst spinal cord stimulation (SCS) provides greater pain relief compared to traditional tonic stimulation, as shown in multiple blinded, sham-controlled, randomized trials.

Patients prefer burst SCS due to its effectiveness in alleviating pain without causing uncomfortable sensations (paresthesias) and its positive impact on both physical and emotional aspects of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Burst Spinal Cord Stimulation: A Clinical Review. Kirketeig, T., Schultheis, C., Zuidema, X., et al.[2020]

Burst spinal cord stimulation (SCS) provides better pain relief than traditional tonic SCS by modulating not only the lateral and descending pain pathways but also the medial pain pathway, which affects the emotional aspects of pain.

A study using fluorodeoxyglucose positron emission tomography (FGD-PET) in seven patients confirmed that burst stimulation significantly activates the dorsal anterior cingulate cortex, indicating a different central neural mechanism compared to tonic stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Neural Activity in Chronic Pain Patients During Tonic and Burst Spinal Cord Stimulation Using Fluorodeoxyglucose Positron Emission Tomography. Yearwood, T., De Ridder, D., Yoo, HB., et al.[2022]

In a long-term follow-up study of patients with failed back surgery syndrome, burst spinal cord stimulation (SCS) significantly reduced back pain intensity by 87.5%, while 10 kHz SCS reduced pain by 54.9%, indicating that burst SCS may be more effective for managing refractory back pain.

Both SCS modalities improved functional outcomes and quality of sleep without any reported complications, suggesting they are safe options for patients, but further research with larger cohorts is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Burst or High-Frequency (10 kHz) Spinal Cord Stimulation in Failed Back Surgery Syndrome Patients With Predominant Back Pain: One Year Comparative Data. Muhammad, S., Roeske, S., Chaudhry, SR., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31152177/

Burst Spinal Cord Stimulation: A Systematic Review and ... Effectiveness data-pain scores and PRO ratings-were weighted by study sample sizes and pooled. The effects of burst SCS were compared against ...

2. academic.oup.com academic.oup.com/painmedicine/article/20/Supplement_1/S47/5509422

Burst Spinal Cord Stimulation: A Systematic Review and ... Effectiveness data—pain scores and PRO ratings—were weighted by study sample sizes and pooled. The effects of burst SCS were compared against ...

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

Spinal Cord Stimulation vs Medical Management for ... This systematic review and network meta-analysis evaluates the efficacy associated with conventional and novel spinal cord stimulation ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S152994302100855X

Burst spinal cord stimulation can attenuate pain and its ... Our results showed that B-SCS appears to be as effective in a chronic pain population with high psychological distress as in those without distress.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03681262

Comparing Long-term Effectiveness of High Frequency ... Spinal cord stimulation is an effective treatment for chronic pain resulting in >50% pain relief in about half of the patients. Novel waveforms for spinal cord ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9364520/

Burst Spinal Cord Stimulation in the Management of Chronic ... The results demonstrated that burst SCS could be as effective in a chronic pain patients for those with high psychological problems versus ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P010032S191B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA ( ... Spinal cord stimulation for chronic refractory pain: Long- term effectiveness and safety data from a multicentre registry. European journal of pain (London ...

8. tandfonline.com tandfonline.com/doi/full/10.2217/pmt-2022-0091

Long-term Safety of Spinal Cord Stimulation Systems in A ... Research article: Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain.