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

7 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Burst spinal cord stimulation and High frequency spinal cord stimulation for chronic pain?

Research shows that both burst and high-frequency spinal cord stimulation can help reduce chronic pain, especially in conditions like failed back surgery syndrome. These newer methods have shown promise compared to traditional spinal cord stimulation, but more studies are needed to fully understand their effectiveness. ^{1 2 3 4 5}

Is spinal cord stimulation safe for treating chronic pain?

Spinal cord stimulation, including burst and high-frequency types, is generally considered safe for treating chronic pain, as it has been used effectively for conditions like failed back surgery syndrome and neuropathic pain. ^{1 3 5 6 7}

How is burst spinal cord stimulation different from other treatments for chronic pain?

Burst spinal cord stimulation is unique because it provides pain relief without causing the tingling sensation (paresthesia) that is common with other spinal cord stimulation methods. It works by targeting additional pain pathways in the brain, which may help with the emotional and motivational aspects of pain, offering potentially better relief than traditional methods. ^{1 3 7 8 9}

What is the purpose of this trial?

Over 100 million Americans suffer from chronic pain resulting in annual cost of roughly $635 billion. Limited treatments are available for this widespread disease. The data supporting these treatments lack generalizability to patients with more serious medical and psychological comorbidities who are often excluded from explanatory efficacy trials. This study aims to integrate randomized comparative effectiveness research with patient care. The investigators will randomize the patients and collect data using an open-source learning healthcare system already in use in the department to monitor patients' progress: Collaborative Health Outcomes Information Registry (CHOIR). CHOIR uses the National Institute of Health Patient Reported Outcomes Measurement Information System item banks for comparative metrics through computer adaptive testing. The investigators will leverage the advantage of this novel system to compare effectiveness of high frequency and burst spinal cord stimulation in improving pain and function in patients with chronic back and/or leg pain. 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 stimulation - high frequency and burst - increased the efficacy of this treatment even further. However, there is lack of data guiding decision making of the clinicians in choosing the best waveform in treating the patients with chronic pain. The proposed study will provide the clinicians with this evidence. Currently, data about safety and efficacy of these two novel waveforms is available for up to 24 months. The proposed research will provide data about effectiveness of these two modalities for at least 36 months. Moreover, this study will evaluate feasibility of integrating randomized comparative effectiveness research with patient care in Stanford Pain Management subspecialty clinic. CHOIR can then be applied for numerous future trials to advance knowledge in perioperative and pain medicine.

Research Team

Vafi Salmasi, MD.

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Burst Spinal Cord Stimulation: A Clinical Review. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Stanford Pragmatiec Effectiveness Comparison (SPEC) protocol: Comparing long-term effectiveness of high-frequency and burst spinal cord stimulation in real-world application. [2021]

3. United States 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. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Fiber Threshold Accommodation as a Mechanism of Burst and High-Frequency Spinal Cord Stimulation. [2022]

5. United States 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A prospective, randomised, double-blind, placebo-controlled study to examine the effectiveness of burst spinal cord stimulation patterns for the treatment of failed back surgery syndrome. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Burst spinal cord stimulation evaluated in patients with failed back surgery syndrome and painful diabetic neuropathy. [2022]

8. United States 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Burst and Tonic Spinal Cord Stimulation: Different and Common Brain Mechanisms. [2022]