Spinal Cord Stimulation for Postoperative Pain

(SPARK 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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to determine the effectiveness of spinal cord stimulation in patients with post intra-thoracic surgery pain syndrome in a placebo-controlled, crossover, randomized clinical trial.

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 the treatment Spinal Cord Stimulation for Postoperative Pain?

Research shows that spinal cord stimulation can effectively reduce chronic pain and improve quality of life, especially in conditions like failed back surgery syndrome. Additionally, transcutaneous electrical nerve stimulation (TENS), a similar method, has been shown to reduce postoperative pain and the need for pain medication after surgeries. ^{1 2 3 4 5}

Is spinal cord stimulation safe for humans?

Spinal cord stimulation, including methods like Epidural Electrical Stimulation (EES) and Transcutaneous Spinal Cord Stimulation (tSCS), is generally considered safe and has been used for decades. It is a minor procedure aimed at providing effective treatment while minimizing risks of adverse events. ^{6 7 8 9 10}

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

Spinal cord stimulation (SCS) is unique because it uses electrical pulses to relieve pain by targeting the spinal cord directly, which is different from typical pain medications that work through the bloodstream. This treatment can be administered through implanted electrodes or non-invasive methods like transcutaneous spinal cord stimulation (tSCS), offering options for patients who may not respond well to conventional pain treatments. ^{3 9 11 12 13}

Research Team

Lutz Weise, MD, PhD

Principal Investigator

Nova Scotia Health Authority

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Stimulation On Experimental Treatment 1 Intervention

Spinal cord stimulators will be optimized to each participant and then programmed to deliver high frequency stimulation below detectable threshold for 6 weeks.

Group II: Stimulation Off Placebo Group 1 Intervention

Spinal cord stimulators will be optimized to each participant as in the experimental arm, and then programmed to deliver no stimulation for 6 weeks.

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

The effect of transcutaneous electrical nerve stimulation on post-thoracotomy pain. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Evaluating efficacy and feasibility of transcutaneous electrical nerve stimulation for postoperative pain after video-assisted thoracoscopic surgery: A randomized pilot trial. [2017]

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

Treatment of chronic pain by epidural spinal cord stimulation: a 10-year experience. [2011]

4. China pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic non-cancer pain: a review of current evidence and practice. [2018]

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

Reduction of postoperative pain and narcotic use by transcutaneous electrical nerve stimulation. [2004]

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

Anticipating and preventing complications in spinal cord stimulator implantation. [2023]

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

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

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

Spinal Direct Current Stimulation Modulates Short Intracortical Inhibition. [2022]

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

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. [2022]

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

Characterization and applications of evoked responses during epidural electrical stimulation. [2023]

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

Spinal cord stimulation for intractable pain following limb amputation. [2022]

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

New technique for open placement of paddle-type spinal cord stimulator electrode in presence of epidural scar tissue. [2022]

13. Spain pubmed.ncbi.nlm.nih.gov

[Spinal cord stimulation and failed back surgery syndrome. Clinical results with laminectomy electrodes]. [2015]