Burst-SCS for Chronic Pain

Overseen By Scott Lempka, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Pregnancy, Artificial nails, Uncooperative, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

20 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 study coordinator or your doctor.

What data supports the effectiveness of the treatment Burst-SCS for chronic pain?

Research shows that Burst-SCS, a type of spinal cord stimulation, can effectively reduce chronic pain in the trunk and limbs, and may also help decrease the need for opioid pain medications. It has been found to provide good pain relief without causing the tingling sensation (paresthesia) that traditional methods might cause. ^{1 2 3 4 5}

Is Burst-SCS safe for humans?

Research studies, including the SUNBURST trial, have evaluated Burst-SCS for chronic pain and found it generally safe for humans. Burst-SCS is a type of spinal cord stimulation that can reduce pain without causing the tingling sensation (paresthesia) often associated with traditional methods. ^{1 2 3 5 6}

How is Burst-SCS treatment different from other treatments for chronic pain?

Burst-SCS is unique because it uses a cluster of five pulses at a fixed rate, which modulates different pain pathways compared to conventional spinal cord stimulation. It provides better pain relief with minimal sensation of paresthesia (tingling or prickling) and targets both the emotional and motivational aspects of pain, unlike traditional methods. ^{2 5 7 8 9}

What is the purpose of this trial?

Recently a new form of spinal cord stimulation therapy called burst spinal cord stimulation (Burst-SCS) is available to treat chronic pain. The goal of this study is to learn more about how Burst-SCS works to reduce chronic pain. The study will examine chronic pain patients who have been deemed candidates for Burst-SCS therapy, and who have already been selected to receive a temporary externalized trial of Burst-SCS from their own doctors as part of their standard clinical care for chronic pain management. During the study, participants will be asked to complete a variety of evaluations at certain time points. In addition, there will be a randomized, double blind, crossover phase, where the particular effects of Burst-SCS and sham SCS will be evaluated. The device used to deliver Burst-SCS and sham SCS is the St. Jude Medical Invisible Trial System.

Research Team

Scott Lempka, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for men and women with chronic pain due to back issues or failed surgery, who are recommended Burst-SCS treatment. Participants must speak English and not be pregnant. They should be able to complete the study without any conditions that could interfere, as judged by the coordinator.

Inclusion Criteria

I have long-lasting pain in my back or limbs, not relieved by surgery, and Burst-SCS is recommended for me.

Candidates who can speak, read, and understand English

Exclusion Criteria

Subjects who are unable or unwilling to cooperate with clinical testing

Subjects having any impairment, activity or situation that, in the judgement of the study coordinator or PI, would prevent satisfactory completion of the study protocol

Subjects who are pregnant- as determined by verbal report or chart review

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-implant Evaluation

Participants complete evaluations such as BPI-SF, SFMPQ, FSQ, VAS, PDI, and MBM to assess baseline pain levels

up to 2 weeks

Randomized Crossover Treatment

Participants undergo a crossover phase with Burst-SCS and sham SCS, with evaluations before and after each stimulation

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Burst-SCS
• Sham SCS

Trial Overview The study tests a new therapy called Burst-SCS against a sham (fake) procedure in people with chronic pain. It involves evaluations over time and uses a device from St. Jude Medical during a randomized, double-blind crossover phase to compare effects.

Participant Groups

Group I: Sham SCS/Burst-SCS Experimental Treatment 2 Interventions

First, participants will receive sham (no) SCS. Study evaluations will be completed prior to and after this sham. Then, participants will have their stimulation adjusted to receive clinically-effective Burst-SCS per their standard of care. Study evaluations will be completed prior to and after stimulation.

Group II: Burst-SCS/sham SCS Experimental Treatment 2 Interventions

First, participants will receive clinically-effective Burst-SCS per their standard of care. Study evaluations will be completed prior to and after stimulation. Then, participants will have their stimulation adjusted to receive sham (no) SCS. Study evaluations will be completed prior to and after this sham.

Burst-SCS is already approved in United States for the following indications:

Approved in United States as BurstDR for:

• Chronic back pain
• Failed back surgery syndrome
• Diabetic peripheral neuropathy
• Non-surgical back pain

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

The SUNBURST study, involving 100 subjects with chronic pain, found that burst spinal cord stimulation is both safe and effective, showing superiority over traditional tonic stimulation in pain relief (p < 0.017).

A significant majority of participants (70.8%) preferred burst stimulation over tonic stimulation, and this preference remained high (68.2%) even after one year, indicating a favorable long-term acceptance of the burst stimulation mode.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. Deer, T., Slavin, KV., Amirdelfan, K., et al.[2022]

In a retrospective review of 3 patients with chronic abdominal pain, BurstDR spinal cord stimulation (SCS) showed promising results, with 2 patients becoming entirely pain-free and reporting significant improvements in their pain scores after more than 24 months.

The third patient experienced a notable reduction in pain frequency and severity, successfully discontinuing all narcotic medications, indicating that BurstDR SCS may be a viable long-term treatment option for various abdominal pain syndromes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of BurstDR Spinal Cord Stimulation for Chronic Abdominal Pain: A Clinical Series. Richter, B., Novik, Y., Bergman, JJ., et al.[2020]

In the SUNBURST study involving 100 patients with chronic pain, the use of a spinal cord stimulation device led to a significant reduction in opioid consumption after 12 months, with an average decrease from 79.19 to 53.94 morphine milligram equivalents (MME).

By the end of the study, 15.9% of patients had completely discontinued opioid use, and there was a notable 61.7% reduction in patients taking more than 120 MME/day, highlighting the device's potential to lower opioid dependency and associated risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation With Burst and Tonic Stimulation Decreases Opioid Consumption: A Post Hoc Analysis of the Success Using Neuromodulation With BURST (SUNBURST) Randomized Controlled Trial. D'Souza, RS., Strand, N.[2022]

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]

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 65-year-old woman with complex regional pain syndrome (CRPS) experienced significant pain relief using burst spinal cord stimulation (SCS), reducing her pain score from 8 to 2 and maintaining this relief for 2 years.

Burst SCS, which delivers rapid pulses at a subthreshold level, proved more effective than conventional tonic stimulation for this patient, demonstrating its potential for long-term pain management in CRPS cases where traditional methods fail.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Burst Spinal Cord Stimulation in a Patient with Complex Regional Pain Syndrome: A 2-year Follow-Up. Kriek, N., Groeneweg, G., Huygen, FJ.[2019]

Burst spinal cord stimulation (SCS) uses a five-pulse cluster to treat chronic pain, but in a study with 7 sheep, it did not show significant differences in activating the anterolateral system (ALS) compared to conventional SCS, which uses single pulses.

While conventional SCS had higher thresholds for evoked compound action potentials and a wider therapeutic dosing range, both stimulation methods did not result in unique changes in ALS activation, suggesting that burst SCS may not provide additional benefits over conventional SCS in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using evoked compound action potentials to quantify differential neural activation with burst and conventional, 40 Hz spinal cord stimulation in ovines. Dinsmoor, DA., Usoro, JO., Barka, ND., 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]

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]

References

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

Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. [2022]

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

The Efficacy of BurstDR Spinal Cord Stimulation for Chronic Abdominal Pain: A Clinical Series. [2020]

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

Neuromodulation With Burst and Tonic Stimulation Decreases Opioid Consumption: A Post Hoc Analysis of the Success Using Neuromodulation With BURST (SUNBURST) Randomized Controlled Trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

Burst Spinal Cord Stimulation in a Patient with Complex Regional Pain Syndrome: A 2-year Follow-Up. [2019]

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

Using evoked compound action potentials to quantify differential neural activation with burst and conventional, 40 Hz spinal cord stimulation in ovines. [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 or High-Frequency (10 kHz) Spinal Cord Stimulation in Failed Back Surgery Syndrome Patients With Predominant Back Pain: One Year Comparative Data. [2022]