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

Trial Summary

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 data supports the effectiveness of the treatment Spinal Cord Stimulation for Lower Back Pain?

Research shows that spinal cord stimulation (SCS) can provide significant long-term pain relief for more than 50% of patients with chronic pain, including those with conditions like peripheral vascular disease and angina. In a study of over 1300 patients, more than half reported a significant improvement in pain and reduced need for pain medication for over three years. ^{1 2 3 4 5}

Is spinal cord stimulation generally safe for humans?

Spinal cord stimulation (SCS) is generally considered a safe treatment for chronic pain conditions like complex regional pain syndrome and failed back surgery syndrome. However, while the overall complication rates are well documented, the risk of serious complications like spinal cord injury is not fully known. ^{2 6 7 8 9}

How does the treatment Spinal Cord Stimulation for Lower Back Pain differ from other treatments?

Spinal Cord Stimulation (SCS) is unique because it involves surgically implanting electrodes to send electrical signals to the spinal cord, which can help modulate and reduce pain. Unlike other treatments, SCS is specifically designed for patients who have not found relief from conventional pain management methods. ^{1 2 4 7 10}

What is the purpose of this trial?

The purpose of this study in patients undergoing routine care epidural spinal cord stimulation (SCS) is to determine 1) whether SCS reduces arterial blood pressure (BP) in patients which chronic low back pain and hypertension, 2) whether higher baseline BP (i.e., hypertension) predicts reductions in pain following SCS, and finally 3) whether different SCS waveforms elicits stimulus-evoked compound action potentials (ECAPs) in spinal cord and at the cortex (electroencephalography, and magnetoenchphalography).

Research Team

Marshall Holland, MD

Principal Investigator

The University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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 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]

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]

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 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 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]

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]

References

1. United States 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. [2019]

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

Spinal cord stimulation for low back pain. [2023]

3. Singapore pubmed.ncbi.nlm.nih.gov

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

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

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

5. Austria pubmed.ncbi.nlm.nih.gov

Neurosurgical pain therapy with epidural spinal cord stimulation (SCS). [2019]

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

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

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

Use of observational mechanical gateway connector in spinal cord stimulation trials. [2011]

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

Techniques for Safe Removal of Spinal Cord Stimulation Paddle Leads. [2022]

9. 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]

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

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