Spinal Cord Stimulation for Postoperative Pain

(MIDL-SCS Trial)

Overseen By Lutz Weise, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Uncontrolled psychiatric, Substance abuse, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new type of spinal cord stimulation can reduce pain that persists after surgery and resists other treatments. It compares a new method (DL-SCS) to both a traditional method and no treatment. Participants will try different combinations of spinal cord stimulation and report changes in their pain. The trial seeks participants who have undergone surgery and continue to experience pain in one body part that does not improve with medication or therapy. As an unphased trial, it offers a unique opportunity to explore innovative pain management solutions that might not be available elsewhere.

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 prior data suggests that this spinal cord stimulation is safe for treating postoperative pain?

Studies have shown that spinal cord stimulation (SCS) is generally safe and well-tolerated. Research indicates that after SCS, pain levels significantly improve, with some reports noting a 45% reduction in pain. However, rare cases of serious side effects, such as loss of movement in the legs, have occurred, though these are uncommon.

For DL-SCS (dorsolateral spinal cord stimulation) and M-SCS (another type of spinal cord stimulation) treatments, safety data is similar. Both methods have proven effective for managing chronic pain and have been used successfully. While long-term safety information is somewhat limited, available evidence suggests that both treatments are minimally invasive and generally safe for most patients.

Overall, despite some risks, SCS treatments are widely used and considered safe options for managing chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about spinal cord stimulation (SCS) for postoperative pain because it works differently from standard pain medications, which often rely on opioids or NSAIDs. Unlike these traditional treatments, SCS uses electrical signals to interfere with the pain messages sent to the brain, potentially providing relief without the side effects associated with medications. This trial explores several SCS methods, including DL-SCS and M-SCS, which use high-frequency, paresthesia-free programs to avoid the tingling sensations common in older SCS technologies. By targeting the spinal cord directly, these approaches aim to offer a more effective and comfortable pain management solution post-surgery.

What evidence suggests that this trial's treatments could be effective for post-surgical neuropathic pain?

Studies have shown that spinal cord stimulation (SCS) can greatly reduce pain in people with long-term pain conditions. This trial may involve different types of SCS treatments for participants. Research indicates that 40% of patients experienced more than a 50% reduction in pain after DL-SCS treatment. M-SCS has also proven effective, with some studies showing a 45% improvement in pain levels. Using DL-SCS and M-SCS together may offer even better pain relief, as each method works differently. Overall, SCS treatments have shown promise in reducing pain and improving the quality of life for many patients. ^{1 6 7 8 9}

Who Is on the Research Team?

Lutz Weise, MD, PhD

Principal Investigator

Nova Scotia Health Authority

Are You a Good Fit for This Trial?

Inclusion Criteria

Having informed consent

I have pain after chest surgery.

I am healthy enough for brain surgery.

Exclusion Criteria

History of previous spinal cord stimulation

Presence of electrical or other devices that preclude implantation of a spinal cord stimulator device

Lack of informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Stimulation On

Spinal cord stimulators are optimized and programmed to deliver high frequency stimulation below detectable threshold for 6 weeks

6 weeks

Treatment - Stimulation Off

Spinal cord stimulators are optimized and programmed to deliver no stimulation for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Regular follow-up appointments at 4, 10, 16, 26, and 52 weeks post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Spinal Cord Stimulation

Trial Overview

This study is looking at how well spinal cord stimulation helps with pain after chest surgery. It's a controlled trial where patients are randomly chosen to receive either the real treatment or a placebo, and then they switch.

How Is the Trial Designed?

Group I: M-SCS Only Experimental Treatment 1 Intervention

The M-SCS electrode will be activated with a high-frequency, paresthesia free program.

Group II: DL-SCS Only Experimental Treatment 1 Intervention

The DL-SCS electrode will be activated with a high-frequency paresthesia-free program.

Group III: DL-SCS + M-SCS Experimental Treatment 1 Intervention

Both DL-SCS and M-SCS will be activated with high-frequency, paresthesia free programs.

Group IV: Stimulation Off Placebo Group 1 Intervention

Both electrodes will be programmed for sham stimulation.

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

Approved in United States as Spinal Cord Stimulation for:

• Failed back surgery syndrome (FBSS)
• Adhesive arachnoiditis
• Peripheral causalgia/neuropathy
• Reflex sympathetic dystrophy (RSD)
• Phantom limb/stump pain
• Ischemic pain of vascular origin
• Complex regional pain syndrome
• Pain after an amputation
• Visceral abdominal pain and perineal pain

Approved in European Union as Spinal Cord Stimulation for:

• Chronic pain
• Neuropathic pain
• Spinal cord injury pain
• Failed back surgery syndrome (FBSS)
• Adhesive arachnoiditis
• Peripheral causalgia/neuropathy
• Reflex sympathetic dystrophy (RSD)

Approved in Canada as Spinal Cord Stimulation for:

• Chronic pain
• Neuropathic pain
• Spinal cord injury pain
• Failed back surgery syndrome (FBSS)
• Adhesive arachnoiditis
• Peripheral causalgia/neuropathy
• Reflex sympathetic dystrophy (RSD)

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Published Research Related to This Trial

Spinal cord stimulation (SCS) is generally a safe and effective treatment option, with complications being uncommon according to a comprehensive literature review.

The review emphasizes the importance of proper patient selection and adherence to evidence-based guidelines to minimize the risk of complications during SCS implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticipating and preventing complications in spinal cord stimulator implantation. Falowski, SM., Tan, H., Parks, J., et al.[2023]

Transcutaneous spinal direct current stimulation (tsDCS) is a safe technique that can effectively modulate spinal cord excitability, as shown by changes in motor-evoked potentials (MEPs) in healthy subjects after stimulation.

The study found that cathodal tsDCS increased MEP amplitudes indicating enhanced inhibitory GABA(A)ergic drive, while anodal tsDCS had the opposite effect, suggesting tsDCS could be a promising rehabilitation strategy for patients with acute brain lesions or spinal diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Direct Current Stimulation Modulates Short Intracortical Inhibition. Bocci, T., Barloscio, D., Vergari, M., et al.[2022]

Epidural electrical stimulation (EES) has been used therapeutically for many years, but understanding its exact mechanism of action remains unclear; this study investigates the evoked compound action potential (ECAP) as a measure of local neural activity during EES.

The research demonstrates that the ECAP component in epidural spinal recordings can help detect lead migration, a potential complication that may affect the effectiveness of EES therapy, and shows concurrent activation of back and leg muscles during stimulation, which could inform future EES system designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization and applications of evoked responses during epidural electrical stimulation. Verma, N., Romanauski, B., Lam, D., et al.[2023]

Spinal cord stimulation (SCS) has shown long-term effectiveness in providing pain relief for some patients with amputation-related pain, with a mean self-reported pain relief of 66% over a follow-up period of up to 19 years.

While some patients experienced technical issues or waning benefits, the overall results suggest that SCS remains a viable treatment option, warranting further refinement of techniques to enhance its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for intractable pain following limb amputation. McAuley, J., van Gröningen, R., Green, C.[2022]

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]

Epidural spinal cord stimulation was effective in controlling pain for 40% of the 121 patients studied, with a mean follow-up of 40 months, particularly benefiting those with pain from conditions like arachnoiditis and multiple sclerosis.

While the treatment showed promise for many, it was less effective for certain types of pain, such as that from cauda equina injury or primary bone diseases, and complications like infection and electrode issues were noted, indicating the need for careful patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of chronic pain by epidural spinal cord stimulation: a 10-year experience. Kumar, K., Nath, R., Wyant, GM.[2011]

Transcutaneous spinal cord stimulation (tSCS) shows potential for generating motor activity in individuals with spinal cord injury, but the overall quality of the studies reviewed was poor-to-fair, indicating a need for more rigorous research.

The review identified significant variability in stimulation parameters and outcome measurements across the 25 studies analyzed, highlighting the necessity for standardized methods to improve the reliability and comparability of tSCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. Taylor, C., McHugh, C., Mockler, D., et al.[2022]

A novel surgical technique was developed for the safe placement of paddle-type spinal cord stimulation (SCS) electrodes in patients with epidural scar tissue, successfully applied in eight patients without complications.

This technique involves creating a laminotomy trough to facilitate dissection of scar tissue, ensuring safe electrode placement and adequate coverage, addressing challenges that can lead to spinal cord injury during conventional placement methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New technique for open placement of paddle-type spinal cord stimulator electrode in presence of epidural scar tissue. Pabaney, AH., Robin, AM., Schwalb, JM.[2022]

In a study of 119 patients with failed back surgery syndrome, spinal cord stimulation using laminectomy lead placement under epidural anaesthesia resulted in satisfactory pain relief, with 58% improvement in axial pain and 60% in radicular pain after an average follow-up of 4.7 years.

The technique was found to be safe, with no serious complications reported, and patients did not experience pain during the procedure, although 6 patients required explantation of the system due to ineffectiveness or intolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Spinal cord stimulation and failed back surgery syndrome. Clinical results with laminectomy electrodes]. García March, G., Bordes, V., Roldán, P., et al.[2015]

Spinal cord stimulation effectively reduces neuropathic pain and improves quality of life, particularly in patients with failed back surgery syndrome when other treatments have not worked.

Newer stimulation techniques, such as burst and high-frequency stimulation, show promise for providing better pain relief compared to traditional methods, although complications can occur, they are generally not life-threatening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic non-cancer pain: a review of current evidence and practice. Wong, SS., Chan, CW., Cheung, CW.[2018]

Citations

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The primary outcome (>50% leg pain relief) in the intent-to-treat analysis was achieved by 40% (95% CI: 27–54%) of SCS patients at 9 months, 31% (18–43%) at 12 ...

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Patients treated with either conventional SCS or novel SCS achieved a statistically significantly greater reduction in pain intensity in the ...

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Studies have shown that early st-SCS significantly improves pain control and sleep quality, potentially preventing PHN progression (15, 16).

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Evidence suggests that SCS significantly reduces acute pain, achieving over a 50% reduction in VAS scores. For chronic pain associated with FBSS ...

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341613 Spinal Cord Stimulation: An Analysis of Adverse ...

Dorsal column stimulator (DCS) implantation has resulted in cases of postoperative paraplegia, though this has not been well-studied. Consultation, ...

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pmc.ncbi.nlm.nih.gov

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Clinical Outcomes after Spinal Cord Stimulation According to ...

After SCS, the pain time score improved by 45% (independent t-test, p=0.0002) and the deep pain score improved by 58% (independent t-test, p=0.001).

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Although SCS and DRG stimulation are well-established and safe treatments for chronic pain, the long-term explantation risk remains high.

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The present study applies machine learning to predict which patients will respond to SCS based on intraoperative electroencephalogram (EEG) data ...