Spinal Cord Stimulation for Peripheral Neuropathy

Overseen By Uchechi Okafor

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Must be taking: Gabapentin, Pregabalin

Disqualifiers: Severe comorbidities, Spinal disease, Coagulopathy, Hemoglobin A1c > 10, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective randomized control trial. Participants enrolled into the study will be randomized into one of three groups, two of which are treatment groups and the third is a control group. A time course of measurements before and after spinal cord stimulation (SCS) treatment (where applicable) will assess pain, DPN severity, small fiber nerve activity, and metabolic health markers.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants must be unable to discontinue blood thinning medications to be excluded. This suggests that some medications might need to be stopped, but it's not clear which ones.

What data supports the effectiveness of the treatment Spinal Cord Stimulation for Peripheral Neuropathy?

Research shows that spinal cord stimulation (SCS) can help reduce chronic pain in people with peripheral neuropathy, especially when other treatments haven't worked. Studies have found that SCS can lower pain intensity and improve outcomes for patients with this condition. ^{1 2 3 4 5}

Is spinal cord stimulation generally safe for humans?

Spinal cord stimulation (SCS) is generally considered safe, but there are some risks like infection, electrode movement, and rare allergic reactions. Some people may experience new pain after the procedure, and while spinal cord injury is a serious concern, its occurrence is not well-documented. ^{6 7 8 9 10}

How is the treatment Spinal Cord Stimulation different from other treatments for peripheral neuropathy?

Spinal Cord Stimulation (SCS) is unique because it involves implanting a device that sends electrical signals to the spinal cord to reduce pain, which is different from taking medications or undergoing physical therapy. This treatment is particularly useful for chronic pain that doesn't respond to standard pain management methods. ^{2 3 5 11 12}

Research Team

Brian Dalm, MD

Principal Investigator

Ohio State University

Eligibility Criteria

This trial is for individuals with diabetic neuropathy or peripheral neuropathy, which are conditions causing nerve pain and damage. Participants should be adults who can give informed consent and have a history of chronic pain despite treatment. They must not have any contraindications to SCS therapy.

Inclusion Criteria

I passed a brain function test before surgery.

DN4 score ≥4

I am over 18 years old.

Exclusion Criteria

Hemoglobin A1c level greater than 10

My doctor thinks my other health issues are too severe for surgery.

I have a blood clotting disorder that cannot be fixed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into one of three groups: two treatment groups with spinal cord stimulation (SCS) and one control group. Treatment involves immediate or delayed activation of SCS.

18 months

Follow-up

Participants are monitored for changes in neuropathic symptoms, pain levels, and quality of life using various instruments.

18 months

Treatment Details

Interventions

• Spinal Cord Stimulator Implantation

Trial Overview The study tests Spinal Cord Stimulator (SCS) Implantation's effectiveness in reducing pain and improving nerve function in patients with nerve damage from diabetes or other causes. It randomly assigns participants into two treatment groups or one control group to compare outcomes.

Participant Groups

Group I: Conventional Medical Management (CMM). Group1 Active Control 1 Intervention

Group II: Spinal Cord Stimulator (SCS) Delayed activation. Group 3 Active Control 1 Intervention

Group III: Spinal Cord Stimulator (SCS) immediate activation. Group 2 Active Control 1 Intervention

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

Approved in United States as Spinal Cord Stimulation for:

• Chronic pain
• Failed back surgery syndrome
• Complex regional pain syndrome
• Diabetic neuropathy
• Cancer-related neuropathy
• Peripheral vascular disease
• Arachnoiditis
• Spinal cord injuries
• Post-surgical pain
• Visceral abdominal pain
• Perineal pain

Approved in European Union as Spinal Cord Stimulation for:

• Chronic pain
• Neuropathic pain
• Failed back surgery syndrome
• Complex regional pain syndrome
• Diabetic neuropathy
• Cancer-related neuropathy
• Peripheral vascular disease

Approved in Canada as Spinal Cord Stimulation for:

• Chronic pain
• Neuropathic pain
• Failed back surgery syndrome
• Complex regional pain syndrome
• Diabetic neuropathy
• Cancer-related neuropathy

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Neuright, Inc.

Collaborator

Trials

1

Recruited

60+

Findings from Research

A review of 24 patients with spinal cord stimulators (SCS) revealed that most electrodes were correctly placed in the epidural space of the spinal canal, which is crucial for effective pain management.

However, complications such as misplaced leads, infections, and hematomas were noted, highlighting the importance of proper electrode placement to avoid ineffective treatment and adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulators: typical positioning and postsurgical complications. Zan, E., Kurt, KN., Yousem, DM., et al.[2016]

In a study of 30 patients with peripheral neuropathy who underwent spinal cord stimulation (SCS), 47% achieved long-term success in chronic pain control after an average follow-up of 87 months, indicating SCS can be an effective treatment for this condition.

Patients with causalgic and diabetic neuropathic pain experienced better outcomes with SCS, while those with postherpetic pain and intercostal neuralgia had less favorable responses, suggesting that SCS may be more beneficial for certain types of neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic pain in peripheral neuropathy. Kumar, K., Toth, C., Nath, RK.[2019]

Spinal cord stimulators (SCSs) have shown efficacy in treating resistant peripheral neuropathic pain, as demonstrated in three case studies involving patients with diabetes, HIV, and chemotherapy-related neuropathy.

All three patients experienced significant pain relief after SCS trials, leading to successful permanent implants in two cases, highlighting SCS as a viable option for managing chronic pain when other treatments fail.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of spinal cord stimulators in treating peripheral neuropathy: a case series. Abd-Elsayed, A., Schiavoni, N., Sachdeva, H.[2022]

A study of 1490 veterans receiving spinal cord stimulators (SCS) for chronic pain showed that those with higher pre-surgical pain scores experienced a significant reduction in pain after the procedure, indicating the efficacy of SCS in managing chronic pain.

The study also found a notable decrease in opioid use among veterans post-implant, with 92.4% using opioids before the procedure compared to 86.6% afterward, highlighting the potential of SCS to reduce reliance on opioid medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of a Large Cohort of Veterans Experiencing Musculoskeletal Disorders with Spinal Cord Stimulation in the Veterans Health Administration: Veteran Characteristics and Outcomes. Wandner, LD., Fenton, BT., Goulet, JL., et al.[2022]

Spinal cord stimulation (SCS) therapy significantly reduces pain intensity in patients with length-dependent peripheral neuropathy after 12 months, based on a systematic review of 19 studies involving 376 participants.

Despite the positive findings, the quality of evidence is considered very low, indicating a need for more robust randomized controlled trials to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of pain in length-dependent peripheral neuropathy with the use of spinal cord stimulation: a systematic review. D'Souza, RS., ElSaban, M., Martinez Alvarez, GA., et al.[2023]

A survey of physicians revealed that 77% use deep sedation and 45% use general anesthesia during spinal cord stimulator (SCS) placements, despite recommendations for awake patient feedback during the procedure.

Most physicians (94%) reported no complications related to general anesthesia during SCS placement, indicating a potential safety in its use, but highlighting a discrepancy with current guidelines that recommend against sedation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Spinal Cord Stimulation Lead Placement Under Deep Sedation and General Anesthesia. Hasoon, J., Urits, I., Viswanath, O., et al.[2023]

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]

Spinal cord stimulation (SCS) can provide significant pain relief for patients with chronic neuropathic pain, but there are rare cases of allergic reactions, as seen in two patients who experienced hives and pruritus after device implantation.

The allergic reactions, although uncommon, highlight the need for further research to understand the mechanisms behind these side effects, which may include delayed hypersensitivity or contact dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pruritus and urticaria induced by neurostimulation: A case report and review of literature. Goel, C., Manjunath, A., Kozel, OA., et al.[2023]

In a retrospective case series of three patients, new-onset radicular pain in the L5/S1 dermatome was observed following spinal cord stimulation (SCS) insertion, suggesting potential complications despite the procedure's overall safety.

The cases highlighted the need for careful pre-procedure MRI analysis to avoid complications related to electrode placement, as well as the importance of discussing potential neurological risks with patients during the consent process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case series of new radicular pain following the insertion of spinal cord stimulator. Baranidharan, G., Bretherton, B., Black, S.[2023]

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]

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]

Spinal cord stimulation (SCS) is a promising treatment for chronic pain syndromes, showing potential benefits in managing persistent neuropathic pain and aiding ischemic wound healing.

A case study of a 59-year-old woman demonstrated successful pain relief and improved condition after SCS implantation, highlighting its efficacy in treating complex pain issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation may improve not only intractable pain but also necrotic wounds. Yılmaz, A., Yıldızgören, MT., Melek, İ., et al.[2020]

References

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

Spinal cord stimulators: typical positioning and postsurgical complications. [2016]

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

Spinal cord stimulation for chronic pain in peripheral neuropathy. [2019]

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

Efficacy of spinal cord stimulators in treating peripheral neuropathy: a case series. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Treatment of a Large Cohort of Veterans Experiencing Musculoskeletal Disorders with Spinal Cord Stimulation in the Veterans Health Administration: Veteran Characteristics and Outcomes. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Treatment of pain in length-dependent peripheral neuropathy with the use of spinal cord stimulation: a systematic review. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Percutaneous Spinal Cord Stimulation Lead Placement Under Deep Sedation and General Anesthesia. [2023]

7. England pubmed.ncbi.nlm.nih.gov

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

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

Pruritus and urticaria induced by neurostimulation: A case report and review of literature. [2023]

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

A case series of new radicular pain following the insertion of spinal cord stimulator. [2023]

10. 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]

11. 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]

12. Turkey pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation may improve not only intractable pain but also necrotic wounds. [2020]