Spinal Cord Stimulation for Lower Back Pain

Overseen By Chris Gonzalez, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Neurological disease, Stroke, Cancer, 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: 2

Duration: 4-6 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how spinal cord stimulation, a device implanted to send electrical pulses to the spine, might help people with chronic lower back pain and high blood pressure. Researchers aim to determine if this treatment can lower blood pressure and if individuals with higher initial blood pressure experience greater pain relief. The trial will also examine how different electrical signals affect the brain and spine. People with chronic pain lasting more than three months who are willing to visit a research lab may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that spinal cord stimulation is safe for lower back pain?

Research has shown that spinal cord stimulation (SCS) is generally safe. A large study of patients in everyday settings found that SCS effectively treats chronic pain, with most people handling the treatment well. Common side effects might include mild discomfort or tingling where the device is placed, but serious issues are rare. Another study supported this, showing that SCS has been used safely over a long period. Overall, SCS appears to be a well-tolerated option for managing chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about permanent epidural spinal cord stimulation for lower back pain because it offers a novel approach compared to traditional treatments like medication, physical therapy, or surgery. Unlike these options, which often focus on managing symptoms or correcting structural issues, spinal cord stimulation directly alters how pain signals are processed by the nervous system. This technique involves implanting a device that sends electrical impulses to the spinal cord, potentially providing significant pain relief and improving quality of life without the side effects associated with long-term medication use. Additionally, this method might provide a solution for patients who haven’t found relief through other means, offering a new avenue of hope for chronic pain sufferers.

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

Research has shown that spinal cord stimulation (SCS) can effectively reduce chronic low back pain. In one study, 60% of patients experienced more than a 50% reduction in back pain after using high-frequency SCS for 24 months. Another study found that people with chronic pain felt significant relief with this therapy. Participants in the treatment arm of this trial will proceed with the permanent implantation of a spinal cord stimulator, which sends gentle electrical signals to the spinal cord to help lessen the feeling of pain. This treatment ranks among the most effective ways to manage chronic pain in the last 50 years. ^{3 4 5 6 7}

Who Is on the Research Team?

Marshall Holland, MD

Principal Investigator

The University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-89 who have had chronic lower back pain for over three months, also experiencing high blood pressure. Participants must be willing to visit a research lab, undergo a blood draw, and provide written consent. It's not suitable for those with neurological diseases like dementia or Parkinson's, history of stroke, cancer diagnosis, or inability to follow the study protocol.

Inclusion Criteria

Willing to undergo a blood draw

I have been experiencing chronic pain for over 3 months.

Able to provide written informed consent

Exclusion Criteria

I am currently diagnosed with cancer.

I have had a stroke in the past.

I have a history of a neurological condition like dementia or Parkinson's.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo epidural spinal cord stimulation (SCS) implantation and monitoring of blood pressure and electrophysiological responses

4-6 weeks

Visit 2 (4-6 weeks post-op)

Follow-up

Participants are monitored for safety and effectiveness after SCS implantation, including blood pressure and serological markers

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Permanent Epidural Spinal Cord Stimulation

Trial Overview

The study tests if Permanent Epidural Spinal Cord Stimulation (SCS) can reduce high blood pressure in patients with chronic low back pain. It also examines if higher initial blood pressure predicts pain relief after SCS and how different SCS waveforms affect spinal cord activity and brain responses measured by EEG and MEG.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Patients that proceed with permanent implantation of a spinal cord stimulator.

Group II: Control Active Control 1 Intervention

Patients who do not proceed with permanent implantation of a spinal cord stimulator.

Permanent Epidural 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:

• Chronic back pain
• Neuropathic pain
• Complex regional pain syndrome (CRPS)
• Arachnoiditis
• Stump Pain

Approved in European Union as Spinal Cord Stimulation for:

• Chronic back pain
• Neuropathic pain
• Complex regional pain syndrome (CRPS)
• Arachnoiditis
• Stump Pain

Approved in Canada as Spinal Cord Stimulation for:

• Chronic back pain
• Neuropathic pain
• Complex regional pain syndrome (CRPS)
• Arachnoiditis
• Stump Pain

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

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]

In a study involving over 1300 patients, more than 52% experienced significant long-term pain relief (over 50% improvement) for more than 3 years after receiving spinal cord stimulation (SCS) devices, along with a notable reduction in their use of pain medications.

While the implantation of SCS devices is technically straightforward, there are risks of serious complications like meningitis, highlighting the need for these procedures to be conducted in specialized centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurosurgical pain therapy with epidural spinal cord stimulation (SCS). Kuchta, J., Koulousakis, A., Sturm, V.[2019]

Spinal cord stimulation (SCS) does not show significant long-term benefits in reducing low back pain, function, or quality of life compared to placebo, based on a systematic review of 13 studies with 699 participants.

The evidence suggests that while SCS may slightly improve function and reduce opioid use when added to medical management, the risks of adverse events, including infections and the need for revision surgery, may outweigh these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for low back pain. Traeger, AC., Gilbert, SE., Harris, IA., et al.[2023]

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]

Percutaneous epidural spinal cord stimulation (ESCS) provided complete pain relief in 11.5% of patients and significant pain relief (over 30%) in 71.1% of the 454 patients studied, indicating its efficacy across various pain conditions.

The effectiveness of ESCS varied by disease type and pain location, with better outcomes in conditions like carcinoma/sarcoma and causalgia, and it was generally safe, with no major complications reported during the treatment period, which lasted from less than a week to over a year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of intractable pain with percutaneous epidural spinal cord stimulation: differences in pain-relieving effects among diseases and sites of pain. Shimoji, K., Hokari, T., Kano, T., et al.[2019]

Spinal cord stimulation (SCS) was found to be effective in reducing chronic pain in three out of four patients with various conditions, including spinal cord injury and post-herpetic neuralgia, after a follow-up period of 19 to 25 months.

The study highlights the importance of long-term follow-up to assess the durability of pain relief and potential complications, as one patient experienced pain recurrence due to electrode migration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of chronic pain by spinal cord stimulation. Tseng, SH.[2016]

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]

In a study of 35 patients who underwent spinal cord stimulator (SCS) paddle removal, the procedure was performed safely with a low complication rate, reporting only two cases of superficial infections that were easily treated with antibiotics.

The use of neuromonitoring and fluoroscopy during the procedure contributed to the minimal risk, demonstrating that SCS paddle removal can be effectively managed with careful surgical techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Techniques for Safe Removal of Spinal Cord Stimulation Paddle Leads. Topp, G., Harland, T., Spurgas, M., et al.[2022]

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]

Citations

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