Spinal Cord Stimulation for Chronic Pain

Overseen By David Darrow, MD MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Pacemakers, Pregnant, Prisoners, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

Spinal cord stimulation modulates the nervous system to effectively block pain signals originating from the back and legs. Spinal cord stimulation has been shown to improve chronic pain, improve quality of life, and reduce disability. Unfortunately, spinal cord stimulation has a high trial failure rate and a high long-term failure rate. This study consists of a prospective cohort of patients clinically scheduled to undergo spinal cord stimulation for the treatment of chronic back pain or radiculopathy. Participants will undergo a structured optimization evaluating existing types of stimulation (tonic, burst, and multistim). Each participant will try out all types of available stimulation but be blinded to the type. Over the course of four months, each participant will evaluate each type of stimulation by reporting daily pain scores. Thompson sampling will be used to identify which setting produces the biggest improvement in pain and recommend it for future use. Participants will follow up routinely to collect laboratory, behavioral, and survey responses to test for the feasibility of obtaining data explaining pain phenotype.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of this treatment for chronic pain?

Research shows that spinal cord stimulation (SCS) is effective for managing chronic pain, especially in conditions like failed back surgery syndrome and complex regional pain syndrome. Studies highlight that SCS is a safe, reversible treatment that can improve quality of life without addictive issues or systemic side effects. ^{1 2 3 4 5}

Is spinal cord stimulation generally safe for humans?

Spinal cord stimulation (SCS) is generally considered safe for treating chronic pain, with long-term safety data available from real-world evaluations. However, complications can occur, and the risk of spinal cord injury, although not well quantified, is a concern during electrode implantation. ^{5 6 7 8 9}

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

Spinal cord stimulation (SCS) is unique because it uses electrical impulses to modulate pain perception in the spinal cord, offering a non-drug approach to pain relief. Unlike traditional methods that may cause a tingling sensation (paresthesia), newer SCS patterns like DTM and FAST provide pain relief without this sensation, making them more comfortable for some patients. ^{10 11 12 13 14}

Research Team

David Darrow, MD MPH

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for English-speaking adults aged 22 or older with chronic back pain or radiculopathy, who are scheduled to undergo spinal cord stimulation and have a baseline pain rating of 6 or higher. It excludes those getting permanent implants without a trial, people with pacemakers/neurostimulators, pregnant individuals, those unable to consent, employees/students of the principal investigator (PI), prisoners, and anyone unable to read/use a smartphone.

Inclusion Criteria

I am 22 years old or older.

My pain level is 6 or higher on a scale of 0-10.

English speaker

Exclusion Criteria

I am scheduled for a permanent implant without a trial period.

Employees or students of PI

Pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo spinal cord stimulation with different types of stimulation (tonic, burst, and multistim) over four months, reporting daily pain scores.

16 weeks

Follow-up

Participants are monitored routinely to collect laboratory, behavioral, and survey responses to test for the feasibility of obtaining data explaining pain phenotype.

3 years

Treatment Details

Interventions

• Various Stimulation Patterns

Trial Overview The study tests different patterns of spinal cord stimulation (tonic, burst, multistim) in patients with chronic pain. Participants will be blinded to the type they receive and report daily pain scores over four months. The most effective setting for reducing pain will be identified using Thompson sampling and recommended for future use.

Participant Groups

Group I: Experimental group Experimental Treatment 1 Intervention

Prospective cohort of patients clinically scheduled to undergo spinal cord stimulation for the treatment of chronic back pain or radiculopathy.

Various Stimulation Patterns is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Spinal Cord Stimulation for:

• Chronic back pain
• Radicular pain
• Failed back surgery syndrome
• Neuropathic pain
• Complex regional pain syndrome
• Peripheral vascular disease
• Diabetic neuropathy

Approved in European Union as Spinal Cord Stimulation for:

• Chronic back pain
• Radicular pain
• Failed back surgery syndrome
• Neuropathic pain
• Complex regional pain syndrome
• Peripheral vascular disease
• Diabetic neuropathy
• Visceral abdominal pain
• Perineal pain

Approved in Canada as Spinal Cord Stimulation for:

• Chronic back pain
• Radicular pain
• Failed back surgery syndrome
• Neuropathic pain
• Complex regional pain syndrome
• Peripheral vascular disease
• Diabetic neuropathy

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

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 (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]

A systematic review identified 22 guideline statements for spinal cord stimulation (SCS) in chronic pain treatment from 1998 to 2013, highlighting a need for improved patient selection and therapy durability.

Current guidelines show significant gaps in coverage and evidence synthesis, indicating that updated and more comprehensive guidelines are necessary to enhance patient outcomes and access to neurostimulation therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International neuromodulation society critical assessment: guideline review of implantable neurostimulation devices. Deer, TR., Thomson, S., Pope, JE., et al.[2022]

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 19 patients using spinal cord stimulation (SCS) for chronic pain, 74% preferred stimulation settings that produced sensations (above sensory threshold) over those that did not (below threshold), indicating a strong preference for the former in improving quality of life.

Patients using above threshold stimulation showed significant improvements in depression scores after three months, although they reported worse sleepiness, suggesting that while effective for pain management, this setting may impact sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Evaluation of Patient Usage of Above and Below Threshold Waveforms With Traditional Spinal Cord Stimulation Devices. Owusu, S., Huynh, A., Gruenthal, E., 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 of 212 patients with chronic lower-limb neuropathic pain, spinal cord stimulation (SCS) was found to have a complication rate of 35%, with the majority of complications being benign and manageable.

Despite some complications, including hardware malfunctions and a small number of serious issues like infections and neurological deficits, SCS remains a safe and effective treatment option when patients are carefully selected and surgical techniques are properly applied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is spinal cord stimulation safe? A review of 13 years of implantations and complications. Kleiber, JC., Marlier, B., Bannwarth, M., et al.[2022]

In a study of 8326 patients who underwent spinal cord stimulation (SCS) implantation, the overall incidence of spinal cord injury (SCI) was found to be low at 2.13%, indicating that SCS is a generally safe procedure.

There was no significant difference in the rates of SCI or spinal hematoma between patients receiving percutaneous (2.35%) and paddle (1.71%) electrode implantation, suggesting similar safety profiles for both methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. Petraglia, FW., Farber, SH., Gramer, R., et al.[2022]

A clinical trial is being conducted to compare the effectiveness of new spinal cord stimulation (SCS) patterns, specifically differential target multiplexed (DTM) and fast-acting subperception therapy (FAST), against conventional tonic stimulation for chronic neuropathic pain, involving multiple participants over a structured testing period.

The study will assess pain improvement using a visual analog scale (VAS) and aims to determine which stimulation pattern is most effective for different types of neuropathic pain, while also monitoring for any adverse events related to the new therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the latest new stimulation patterns of spinal cord stimulation for intractable neuropathic pain compared to conventional stimulation: study protocol for a clinical trial. Tanei, T., Maesawa, S., Nishimura, Y., et al.[2023]

In a retrospective study of 62 patients who underwent spinal cord stimulation (SCS) from February 2011 to January 2015, significant reductions in pain severity were observed, indicating its efficacy in managing chronic pain conditions.

Patients also reported improvements in sleep quality and daily activities post-procedure, supporting the reliability of SCS as a treatment option for various pain syndromes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Spinal cord stimulation in 62 patients: Retrospective evaluation]. Özdemir, İ., Akbaş, M., Yeğin, A., et al.[2018]

Spinal cord stimulation (SCS) is an effective treatment for intractable neuropathic pain, showing better outcomes compared to conventional medical management and reoperation, particularly in patients with failed back surgery syndrome.

Recent studies indicate that paresthesia-free SCS methods, such as burst, high-density, and 10-kHz frequency stimulation, are generally superior to traditional tonic SCS, and patients show a strong preference for these newer techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tonic, Burst, High-Density, and 10-kHz High-Frequency Spinal Cord Stimulation: Efficiency and Patients' Preferences in a Failed Back Surgery Syndrome Predominant Population. Review of Literature. Peeters, JB., Raftopoulos, C.[2021]

Spinal cord stimulation (SCS) is an effective treatment for chronic neuropathic pain conditions like Failed Back Surgery Syndrome (FBSS) and Complex Regional Pain Syndrome (CRPS), with 40% of patients no longer needing analgesic medication after 12 months.

The study of 80 patients showed that SCS not only improved pain management but also helped 47% of unemployed patients return to work, demonstrating its significant impact on quality of life with low complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for FBSS and CRPS: A review of 80 cases with on-table trial of stimulation. Gopal, H., Fitzgerald, J., McCrory, C.[2018]

In a study of 19 patients with failed back surgery syndrome, high frequency spinal cord stimulation (HF-SCS) significantly reduced pain levels, with visual analogue scale scores dropping from 71 mm for leg pain and 69 mm for back pain preoperatively to 18 mm and 24 mm, respectively, after 6 months.

The Oswestry Disability Index (ODI) improved from a mean of 63% preoperatively to 24% after 6 months, indicating a substantial enhancement in the patients' quality of life following HF-SCS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Minimally invasive implantation technique of a system for spinal cord stimulation]. Kasapovic, A., Rommelspacher, Y., Walter, S., et al.[2021]

References

1. Austria pubmed.ncbi.nlm.nih.gov

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

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

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

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

International neuromodulation society critical assessment: guideline review of implantable neurostimulation devices. [2022]

4. 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]

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

Prospective Evaluation of Patient Usage of Above and Below Threshold Waveforms With Traditional Spinal Cord Stimulation Devices. [2022]

6. England pubmed.ncbi.nlm.nih.gov

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

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

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

8. France pubmed.ncbi.nlm.nih.gov

Is spinal cord stimulation safe? A review of 13 years of implantations and complications. [2022]

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

The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Efficacy of the latest new stimulation patterns of spinal cord stimulation for intractable neuropathic pain compared to conventional stimulation: study protocol for a clinical trial. [2023]

11. Turkey pubmed.ncbi.nlm.nih.gov

[Spinal cord stimulation in 62 patients: Retrospective evaluation]. [2018]

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

Tonic, Burst, High-Density, and 10-kHz High-Frequency Spinal Cord Stimulation: Efficiency and Patients' Preferences in a Failed Back Surgery Syndrome Predominant Population. Review of Literature. [2021]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for FBSS and CRPS: A review of 80 cases with on-table trial of stimulation. [2018]

14. Germany pubmed.ncbi.nlm.nih.gov

[Minimally invasive implantation technique of a system for spinal cord stimulation]. [2021]