FAST Spinal Cord Stimulation for Chronic Pain

(FAST Trial)

Recruiting at 13 trial locations

Overseen By Diane Keesey

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Disqualifiers: Cognitive impairment, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

177 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 team or your doctor.

What data supports the effectiveness of the treatment Boston Scientific WaveWriter SCS System for chronic pain?

Spinal cord stimulation (SCS) has been shown to be effective in managing chronic pain conditions like failed back surgery syndrome and complex regional pain syndrome, providing pain relief and improving quality of life. The technology, including programmable implanted devices, has advanced significantly, making it a reliable option for patients with chronic pain. ^{1 2 3 4 5}

Is spinal cord stimulation generally safe for humans?

Spinal cord stimulation (SCS) is generally considered a safe treatment for chronic pain conditions, with studies showing it is effective and has a good safety profile. However, specific risks associated with certain procedures, like paddle lead removal, are not well defined in the literature. ^{6 7 8 9 10}

How does the Boston Scientific WaveWriter SCS System treatment differ from other treatments for chronic pain?

The Boston Scientific WaveWriter SCS System is unique because it offers a customizable spinal cord stimulation (SCS) approach, allowing for individual current control across multiple channels, which can be adjusted based on patient feedback. This system is designed to provide significant pain relief without the systemic side effects or addiction risks associated with some other chronic pain treatments. ^{3 11 12 13 14}

What is the purpose of this trial?

This trial is testing a new pain relief treatment that acts quickly and doesn't cause tingling. It targets patients with chronic pain who don't respond well to regular treatments. The treatment uses a device that sends electrical signals to the spine to block pain.

Research Team

Natalie Bloom Lyons

Principal Investigator

Boston Scientific Corporation

Eligibility Criteria

This trial is for adults over 22 with chronic pain, specifically neuropathic pain in the trunk or limbs that's lasted at least 6 months. Participants must be able to read and understand English, complete questionnaires, and have signed an informed consent form. It excludes those with conditions that could affect study results, significant cognitive impairments, pregnant or breastfeeding individuals not using contraception, or anyone in another conflicting clinical trial.

Inclusion Criteria

I have had chronic pain in my back or limbs for at least 6 months, with back pain being the most severe.

I am 22 years old or older.

I have had chronic pain in my back or limbs for at least 6 months, with back pain being as bad or worse than leg pain.

Exclusion Criteria

I am not breastfeeding, planning to become pregnant, or not using birth control.

You have any medical or psychological conditions that could make it difficult to accurately report how you are feeling during the study.

Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive FAST-SCS and other SCS therapies using WaveWriter systems

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Boston Scientific WaveWriter SCS System

Trial Overview The effectiveness of a new therapy called FAST-SCS (fast-acting paresthesia-free) is being tested using the Boston Scientific WaveWriter SCS System on patients with chronic pain. The study will also look into additional SCS therapy options provided by this system.

Participant Groups

Group I: WaveWriter Settings Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

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]

Spinal cord stimulation (SCS) is a low-risk, reversible technique that effectively manages chronic, intractable pain when patients are carefully selected, as shown by multicenter prospective studies.

Recent advancements in electrode placement and programmable electronics have enhanced the implementation of SCS, and ongoing innovations are expected to further improve its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for failed back surgery syndrome and other disorders. Nicholson, CL., Korfias, S., Jenkins, A.[2019]

Spinal cord stimulation has become a low-morbidity technique for managing chronic pain, with recent advancements allowing for easier implantation and adjustment of the system in patients.

A new computerized system for patient interaction has been clinically tested in 25 patients, proving to be safe and effective, and allows for quicker adjustments to the stimulator compared to traditional methods, enhancing the overall management of pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-interactive, computer-controlled neurological stimulation system: clinical efficacy in spinal cord stimulator adjustment. North, RB., Fowler, K., Nigrin, DJ., et al.[2004]

In a study of 44 patients with chronic neuropathic pain from failed back surgery syndrome, 63.6% experienced successful trial stimulation with spinal cord stimulation (SCS).

The use of paddle electrodes was associated with higher success rates for trial stimulation, while severe sensory deficits in painful areas were linked to lower success rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with the success of trial spinal cord stimulation in patients with chronic pain from failed back surgery syndrome. Son, BC., Kim, DR., Lee, SW., et al.[2021]

In a study of 68 patients who had spinal cord stimulation paddle electrodes removed, the most common reason for removal was loss of coverage or effect (75%), indicating that while SCS is effective, it may not always provide lasting relief.

Postoperative complications occurred in 11.75% of patients, with two major complications requiring reoperation, highlighting that while SCS removal is generally safe, it does carry some risks that patients should be aware of.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. Maldonado-Naranjo, AL., Frizon, LA., Sabharwal, NC., et al.[2022]

Spinal cord stimulation (SCS) is effective in improving pain relief, sleep quality, and functional activities in patients with chronic pain, as shown by a survey of 30 patients who reported positive outcomes after receiving different SCS devices.

While there were no significant differences in pain relief and sleep improvement among the three SCS device manufacturers (Medtronic, Advanced Bionics, and ANS), the Advanced Bionics group showed less functional improvement compared to the other two groups, suggesting that device technology may influence certain outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of spinal cord stimulation, overall, and the effect of differing spinal cord stimulation technologies on pain, reduction in pain medication, sleep, and function. Haddadan, K., Krames, ES.[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]

In a study of 402 patients with chronic pain who received spinal cord stimulation (SCS) devices, 55% of those with lower limb pain and 67% with upper limb pain reported a significant reduction in pain (≥50% reduction) after 2 years, indicating the long-term effectiveness of SCS.

The majority of patients (91%) were satisfied with their treatment, and 93% would choose to undergo the procedure again, while also showing a significant decrease in the need for pain medications, highlighting both the efficacy and safety of SCS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic refractory pain: Long-term effectiveness and safety data from a multicentre registry. Brinzeu, A., Cuny, E., Fontaine, D., et al.[2019]

In a study of 35 patients who underwent spinal cord stimulator (SCS) paddle removal, the procedure was performed safely with a low complication rate, reporting only two cases of superficial infections that were easily treated with antibiotics.

The use of neuromonitoring and fluoroscopy during the procedure contributed to the minimal risk, demonstrating that SCS paddle removal can be effectively managed with careful surgical techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Techniques for Safe Removal of Spinal Cord Stimulation Paddle Leads. Topp, G., Harland, T., Spurgas, M., et al.[2022]

In a study involving 49 patients with resistant deafferentation pain, spinal cord stimulation (SCS) was effective, with 57% of those who received permanent implants reporting over 75% pain relief after an average follow-up of 5.5 years.

The procedure had a low incidence of side effects, with only two cases requiring replacement of the stimulator due to electrode dislodgement and wire extrusion, indicating a relatively safe profile for this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation in deafferentation pain. Sánchez-Ledesma, MJ., García-March, G., Diaz-Cascajo, P., et al.[2018]

Spinal cord stimulation (SCS) is a safe and effective treatment for chronic pain, increasingly recognized as a first-line therapy due to its non-addictive nature and minimal systemic side effects.

Recent technological advancements, including multi-lead and multi-electrode arrays, have expanded the applications of SCS, allowing for better treatment options for various pain conditions such as radiculitis and complex regional pain syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and future trends in spinal cord stimulation for chronic pain. Deer, TR.[2022]

In a study of 20 CRPS patients treated with High Frequency 10 kHz spinal cord stimulation (HF10-SCS), significant reductions in pain were observed, with mean pain scores decreasing from 6.1 at baseline to 3.8 at 6 weeks post-operation.

By 6 weeks, 85% of patients reported a greater than 50% reduction in symptoms, indicating that HF10-SCS may be an effective treatment option for managing chronic pain in CRPS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of 10 kHz spinal cord stimulation in complex regional pain syndrome: A retrospective analysis. Sweeney, J., Sheldon, BL., Juneja, A., et al.[2023]

References

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

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

2. Austria pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for failed back surgery syndrome and other disorders. [2019]

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

Patient-interactive, computer-controlled neurological stimulation system: clinical efficacy in spinal cord stimulator adjustment. [2004]

4. Singapore pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic pain. [2020]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Factors associated with the success of trial spinal cord stimulation in patients with chronic pain from failed back surgery syndrome. [2021]

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

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]

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

The effect of spinal cord stimulation, overall, and the effect of differing spinal cord stimulation technologies on pain, reduction in pain medication, sleep, and function. [2022]

8. United States 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic refractory pain: Long-term effectiveness and safety data from a multicentre registry. [2019]

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

Techniques for Safe Removal of Spinal Cord Stimulation Paddle Leads. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation in deafferentation pain. [2018]

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

A new spinal cord stimulation system effectively relieves chronic, intractable pain: a multicenter prospective clinical study. [2022]

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

Current and future trends in spinal cord stimulation for chronic pain. [2022]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of 10 kHz spinal cord stimulation in complex regional pain syndrome: A retrospective analysis. [2023]