Spinal Cord Stimulation for Diabetic Neuropathy

Overseen By Julia T Hoffman, MSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Must not be taking: Antithrombotics

Disqualifiers: Psychiatric disorder, Non-healing wounds, others

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

Compensation: Varies

Number of Visits: 3

15 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you must be able to hold antithrombotic therapy (medications that prevent blood clots) according to specific guidelines.

What data supports the effectiveness of this treatment for diabetic neuropathy?

Research shows that high-frequency spinal cord stimulation (SCS) at 10 kHz can provide effective pain relief and improve quality of life for people with painful diabetic neuropathy. Studies have demonstrated its long-term efficacy and positive impact on nerve function and blood flow in affected areas. ^{1 2 3 4 5}

Is spinal cord stimulation safe for treating diabetic neuropathy?

Research shows that spinal cord stimulation has been evaluated for safety in treating painful diabetic neuropathy, with studies focusing on its effects and any complications over time. ^{1 2 4 6 7}

How is spinal cord stimulation different from other treatments for diabetic neuropathy?

Spinal cord stimulation (SCS) is unique because it uses electrical impulses to manage chronic pain, unlike conventional treatments that often focus on symptom relief and can have significant side effects. SCS has shown promise in improving pain and sensory function in patients with diabetic neuropathy, offering a potential alternative for those who do not respond well to standard therapies. ^{1 2 4 8 9}

What is the purpose of this trial?

Peripheral arterial disease (PAD) affects over 230 million adults worldwide and is a highly morbid, costly, and disabling condition. Ischemic leg pain drives disability in PAD patients and results from oxygen supply-demand mismatch, autonomic dysfunction, and muscle breakdown. This leg pain, which is unresponsive to traditional pharmacotherapy, limits the patient's tolerance to exercise, which is an important disease-modifying intervention. Spinal cord stimulation is a well-established therapy for medically intractable pain, including painful diabetic neuropathy (PDN) and ischemic pain, but is not part of the standard-of-care for PAD despite limited promising clinical data. Early studies used first-generation, tonic stimulation devices, but with these it was impossible to perform sham-controlled trials to test the treatment. Since then, new types of waveform treatments, including high-frequency spinal cord stimulation (SCS), have been shown to be more effective in the treatment of intractable pain. While high-frequency SCS is approved for PDN treatment, it has never been tested in the treatment of claudication pain from PAD. This study will enroll up to 15 participants between the ages of 19 and 89 who have PAD and PDN and are successfully implanted with a permanent SCS. Twelve weeks after SCS implantation, participants will receive two weeks of stimulation and two weeks of sham intervention, in random starting order. Blood flow, blood pressure, skin oxygen levels, and participant reported pain int the lower extremities will be assessed before SCS implantation, 12 weeks after SCS implantation and during each of the treatment periods. Participants will also complete a quality of life survey at the same time points. Comparisons of these measurements with the baseline and post-implantation measurements to determine the effects of SCS.

Research Team

Peter Pellegrino, MD

Principal Investigator

University of Nebraska

Eligibility Criteria

This trial is for adults aged 19-90 with Type 2 Diabetes who suffer from painful diabetic neuropathy and peripheral arterial disease. They must have significant pain from neuropathy and walking, confirmed PAD via tests, a low quality of life score related to vascular issues, and be suitable candidates for spinal cord stimulation therapy.

Inclusion Criteria

I am between 19 and 89 years old and have diabetes.

I am a suitable candidate for a spinal cord stimulator implant.

I experience nerve pain with a severity of at least 5 out of 10.

Exclusion Criteria

My spine is unstable, as shown by specific spine X-rays.

I have wounds that are not healing.

My walking is impaired for reasons not related to peripheral artery disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

SCS Implantation and Optimization

Participants undergo permanent spinal cord stimulator implantation and optimization

12 weeks

1 visit (in-person)

Intervention

Participants receive two weeks of active spinal cord stimulation and two weeks of sham intervention in a cross-over design

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

• Sham stimulation
• Spinal cord stimulation

Trial Overview The study compares the effects of actual spinal cord stimulation (SCS) versus sham (fake) stimulation in managing pain due to diabetic neuropathy and poor blood flow in limbs. Participants will undergo SCS placement, followed by two weeks each of real and sham stimulations in random order over four weeks.

Participant Groups

Group I: Active Spinal Cord Stimulation Experimental Treatment 1 Intervention

Therapeutic spinal cord stimulation titrated at 12 weeks post operative at standard clinical practice.

Group II: Sham Stimulation Placebo Group 1 Intervention

Sub-threshold low frequency spinal cord stimulation to provide no analgesic benefit but serve as a sham control.

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Nevro Corp

Industry Sponsor

Trials

11

Recruited

1,800+

Findings from Research

In a multicenter randomized controlled trial involving 216 participants with refractory painful diabetic neuropathy, 10-kHz spinal cord stimulation (SCS) combined with conventional medical management led to a significant mean pain relief of 74.3% after 12 months, with 85% of participants experiencing at least 50% pain relief.

The treatment also resulted in substantial improvements in health-related quality of life, with 92% of participants reporting satisfaction with the 10-kHz SCS, indicating its effectiveness and durability as a treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Frequency 10-kHz Spinal Cord Stimulation Improves Health-Related Quality of Life in Patients With Refractory Painful Diabetic Neuropathy: 12-Month Results From a Randomized Controlled Trial. Petersen, EA., Stauss, TG., Scowcroft, JA., et al.[2023]

In a study of 216 patients with refractory painful diabetic neuropathy, 10 kHz spinal cord stimulation (SCS) led to a remarkable 79.9% reduction in pain over 24 months, with 90.1% of participants achieving at least 50% pain relief.

The treatment also significantly improved health-related quality of life and sleep, with 65.7% of participants showing clinically meaningful neurological improvements, indicating that 10 kHz SCS is both safe and effective for long-term management of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term efficacy of high-frequency (10 kHz) spinal cord stimulation for the treatment of painful diabetic neuropathy: 24-Month results of a randomized controlled trial. Petersen, EA., Stauss, TG., Scowcroft, JA., et al.[2023]

In a study of 11 diabetic patients with chronic lower limb pain who did not respond to conventional treatments, spinal cord stimulation (SCS) provided significant pain relief, with average pain scores dropping from 77 to 34 over 6 months.

Eight out of nine patients continued to experience substantial pain relief at the end of the study, allowing many to reduce their pain medication, indicating that SCS is an effective and safe therapy for chronic diabetic neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect and safety of spinal cord stimulation for treatment of chronic pain caused by diabetic neuropathy. de Vos, CC., Rajan, V., Steenbergen, W., et al.[2011]

In a study of 19 patients with diabetic foot, spinal cord electrical stimulator implantation significantly reduced pain levels and improved quality of life, as indicated by lower visual analog scale scores and higher QOL scores post-surgery.

The procedure also enhanced nerve conduction velocities and increased blood flow to the lower limbs, achieving a high limb salvage rate of 94.74%, suggesting it is an effective treatment option for preventing toe amputation in diabetic foot patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Effect Analysis of Spinal Cord Electrical Stimulator Implantation for Diabetic Foot. Zhou, PB., Bao, M.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

High-Frequency 10-kHz Spinal Cord Stimulation Improves Health-Related Quality of Life in Patients With Refractory Painful Diabetic Neuropathy: 12-Month Results From a Randomized Controlled Trial. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Long-term efficacy of high-frequency (10 kHz) spinal cord stimulation for the treatment of painful diabetic neuropathy: 24-Month results of a randomized controlled trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

High-frequency spinal cord stimulation (10 kHz) alters sensory function and nerve fiber density in painful diabetic neuropathy: a pilot prospective open-label study. [2023]

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

Effect and safety of spinal cord stimulation for treatment of chronic pain caused by diabetic neuropathy. [2011]

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

Clinical Effect Analysis of Spinal Cord Electrical Stimulator Implantation for Diabetic Foot. [2023]

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

Electrical spinal cord stimulation in painful diabetic polyneuropathy, a systematic review on treatment efficacy and safety. [2018]

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

Severity of Neuropathy Is Associated With Long-term Spinal Cord Stimulation Outcome in Painful Diabetic Peripheral Neuropathy: Five-Year Follow-up of a Prospective Two-Center Clinical Trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Electrical spinal-cord stimulation for painful diabetic peripheral neuropathy. [2015]

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

10-kHz spinal cord stimulation treatment for painful diabetic neuropathy: results from post-hoc analysis of the SENZA-PPN study. [2021]