Spinal Cord Stimulation for Chronic Pain

(MOPPStim Trial)

Overseen By Anuj Bhatia, MD FRCPC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Opioids

Disqualifiers: Previous SCS, Pregnancy, Psychiatric disorders, 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: 12

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests spinal cord stimulation (SCS) to determine its effectiveness in relieving chronic neuropathic pain, particularly after back surgery. It compares traditional SCS, which may cause tingling sensations, with new methods that avoid these sensations. Researchers aim to understand how these treatments work and identify the patients they benefit most, using brain imaging and pain tracking. Individuals with persistent nerve pain in their back or legs after lumbar surgery, who haven't found relief from standard treatments, might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve pain management options.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that your pain should be refractory (not responding) to conventional medical management tried for at least 3 months, which suggests you may continue your current medications if they are not effective.

What prior data suggests that spinal cord stimulation is safe for treating chronic pain?

Research has shown that spinal cord stimulation (SCS) is generally safe for treating chronic pain. In one study, some patients experienced less pain, while others required device removal due to insufficient relief or discomfort. The removal rate can reach up to 38%, often because the expected pain relief isn't achieved.

Another study found that SCS can outperform traditional pain treatments for many individuals, making it a viable option for chronic pain. However, long-term safety data remains limited. A global registry tracked SCS users for over two years and found that most tolerated the treatment well, though some experienced side effects like infections or device-related issues.

Overall, SCS appears to be a safe choice for many, but discussing potential risks and benefits with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about spinal cord stimulation (SCS) for chronic pain because it offers a different approach compared to standard treatments like opioids or physical therapy. Unlike these options, SCS targets pain by delivering electrical pulses directly to the spinal cord, which can block pain signals before they reach the brain. This technique not only provides a non-drug alternative, reducing the risk of addiction, but it also allows for customizable modes like Burst, High Frequency, and High Density, which can be tailored to individual patient needs. This versatility and personalized approach have the potential to significantly improve pain management and quality of life for patients with chronic pain.

What evidence suggests that spinal cord stimulation is effective for chronic pain?

Research has shown that spinal cord stimulation (SCS) can help treat chronic pain. Studies have found that people with long-term back and leg pain often experience significant relief with this treatment. Specifically, those who used SCS for an extended period reported more improvement in their pain levels than those who used it briefly. SCS is also associated with a better quality of life and improved functionality. In this trial, participants will experience different modes of SCS, including paresthesia-based SCS (PB-SCS) and newer paresthesia-free (PF-SCS) versions, which aim to relieve pain without the tingling sensation some people experience with older methods. While scientists continue to explore exactly how SCS works, these early results suggest it could be a promising way to manage chronic pain. ^{2 3 6 7 8}

Who Is on the Research Team?

Anuj Bhatia, MD FRCPC

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with chronic neuropathic pain in the back or lower limbs following lumbar spine surgery, which hasn't improved after at least 3 months of treatment. Participants should have a pain severity over 3/10 and disability score over 40/100. It's not for those with certain psychiatric conditions, pregnant women, people unable to follow the study protocol, spinal instability on X-rays, ongoing litigation related to their pain, other types of neuropathy or myopathy, previous SCS trials or implants.

Inclusion Criteria

You have had ongoing pain that hasn't improved with regular treatments for at least 3 months.

You have pain rated higher than 3 out of 10 and a disability score higher than 40 out of 100.

Exclusion Criteria

Pregnancy

You have instability in your spine that can be seen in certain X-rays.

You are currently involved in legal issues related to the pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

SCS Trial

Participants undergo a percutaneous trial of SCS with different modes: PB-SCS, placebo, and PF-SCS

12 days

Daily visits for 12 days

Post-Trial Assessment

Neuroimaging and psychophysical testing conducted at the end of the SCS trial

1 day

Implantation and Follow-up

Participants who respond well to the trial receive SCS implantation and are monitored for 6 months

6 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Spinal Cord Stimulation

Trial Overview The trial is testing Spinal Cord Stimulation (SCS) methods: traditional paresthesia-based (PB-SCS) and newer paresthesia-free (PF-SCS). It aims to understand how these treatments relieve pain using neuroimaging techniques and determine criteria for selecting patients most likely to benefit from these therapies.

How Is the Trial Designed?

Group I: Spinal Cord Stimulation Experimental Treatment 1 Intervention

At baseline, the following data will be recorded: standard-of-care questionnaire scores, neuroimaging (fMRI, MEG), psychophysical testing (QST), accelerometer sleep and activity data. The trial will proceed as follows: Day 1-4: Paresthesia-based SCS (PB-SCS) Day 5-8: No SCS (placebo) Day 9-12: PF-SCS Neuroimaging and psychophysical testing will be conducted at the end of the trial, and will be assessed 6-months post-implantation of the SCS device along with adverse effects. A decision to implant the SCS system will be made based on reduction of patient pain intensity by 50% in PB-SCS and/or PF-SCS modes, but not with placebo SCS. Based on the response in the trial, the patient will either not be a candidate for an SCS implant, or they will receive one of the four modes upon implantation (PB-SCS, or one of the three PF-SCS: Burst, High Frequency, High Density).

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?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

MSH-UHN AMO Innovation Fund

Collaborator

Trials

3

Recruited

240+

Published Research Related to This Trial

In a study of 48 chronic pain patients using tonic spinal cord stimulation (SCS), it was found that SCS reduced touch sensitivity in the area of the body where stimulation was applied, indicating some effect on sensory perception.

However, the overall impact of SCS on sensory perception was minimal, and the changes observed were not deemed clinically significant, suggesting that SCS may not substantially alter patients' daily experiences of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Tonic Spinal Cord Stimulation on External Mechanical and Thermal Stimuli Perception Using Quantitative Sensory Testing: A Multicenter Stimulation ON-OFF Study on Chronic Pain Patients. Bordeleau, M., Carrondo Cottin, S., Cantin, L., et al.[2021]

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 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]

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]

In a study involving patients undergoing spinal cord stimulation (SCS) trials, the Observational Mechanical Gateway (OMG) Connector provided an additional option for stimulation, leading to an overall pain score reduction from 7.3 to 2.6 on a 10-point scale, indicating effective pain management.

Despite the small sample size, 12 out of 16 participants chose to proceed with permanent implantation after the trial, suggesting that the OMG Connector may enhance patient satisfaction and treatment access during SCS trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of observational mechanical gateway connector in spinal cord stimulation trials. Kim, CH., Issa, MA., Vaglienti, RM.[2011]

Cervical transcutaneous spinal cord stimulation (tSCS) can effectively activate sensory fibers at lower stimulation intensities when the cathode electrode is positioned at the C7 or T1 vertebra, compared to C6, which may enhance rehabilitation outcomes for upper-limb motor recovery after spinal cord injury.

Using smaller electrode sizes not only lowers the activation threshold for sensory fibers but also optimizes the recruitment of these fibers before α-motor fibers, suggesting a strategic approach to improve hand muscle activation during tSCS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. de Freitas, RM., Capogrosso, M., Nomura, T., et al.[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]

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 involving seven patients with traumatic paraplegia and chronic pain, six patients reported good to very good outcomes from epidural electrical stimulation over follow-up periods of up to six years.

The positive effects on chronic pain suggest that epidural electrical stimulation should be considered as a treatment option before resorting to more invasive surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with spinal cord stimulation (SCS) in the management of chronic pain in a traumatic transverse lesion syndrome. Buchhaas, U., Koulousakis, A., Nittner, K.[2019]

In a pilot study involving 7 individuals with chronic spinal cord injury, the use of transcutaneous electrical spinal cord stimulation (TSCS) combined with functional training led to improvements in upper and lower extremity function, with all participants showing progress on the Capabilities of Upper Extremity Test (CUE-T).

Notably, two participants improved their ASIA impairment scale classification, and five individuals experienced enhanced sensation, demonstrating that TSCS can facilitate recovery even after a plateau in rehabilitation progress, without any serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. Tefertiller, C., Rozwod, M., VandeGriend, E., et al.[2022]

Spinal cord stimulation has proven effective for chronic neuropathic pain, particularly in patients with peripheral nerve or posterior root lesions, where other treatments often fail.

In a retrospective study of 84 patients over 16 years, 56 continued to use their stimulators, with 72% reporting satisfactory pain relief, highlighting the importance of trial stimulation for long-term success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Spinal cord stimulation in chronic neuropathic pain]. Meyerson, B., Linderoth, B., Lind, G.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12321793/

The effectiveness of spinal cord stimulation combined with ... This review aims to synthesize current evidence regarding pain relief, functional improvement, and quality of life outcomes associated with this ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6391880/

Spinal Cord Stimulation: Clinical Efficacy and Potential ... Detection and pain thresholds to electrical stimulation were increased in patients implanted chronically compared with those receiving short-term stimulation.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2826172

Spinal Cord Stimulation vs Medical Management for ... This systematic review and network meta-analysis evaluates the efficacy associated with conventional and novel spinal cord stimulation ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1526590023004704

Real World Characterization of Chronic Pain, Success ... Spinal cord stimulation is an effective treatment for those experiencing chronic back and leg pain but requires a temporary evaluation ...

5. dovepress.com dovepress.com/spinal-cord-stimulation-explantation-and-chronic-pain-a-systematic-rev-peer-reviewed-fulltext-article-JPR

Spinal Cord Stimulation Explantation: A Systematic Review ... SCS is an effective treatment for a range of chronic pain conditions, but the therapy requires better durability data to withstand criticism ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11929510/

Spinal Cord Stimulation Explantation and Chronic Pain SCS efficacy varies, with explantation rates reaching up to 38%, often due to inadequate pain relief. Most explantations occur within the first ...

7. tandfonline.com tandfonline.com/doi/full/10.2217/pmt-2022-0091

Long-term Safety of Spinal Cord Stimulation Systems in A ... Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04894734

Spinal Cord Stimulation (SCS) for Spinal Cord Injury (SCI) The purpose of this feasibility study is to compare the impact of Spinal cord stimulation [SCS] for Spinal Cord Injury (SCI) pain and rehabilitation.