20 Participants Needed

Spinal Cord Stimulation for Chronic Lower Back Pain

LC
DC
Overseen ByDaniel C Lu, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Los Angeles
Must be taking: Spinal cord stimulators
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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

The trial protocol does not specify if you need to stop taking your current medications. However, since the study focuses on spinal cord stimulation and aims to reduce reliance on drugs, it's possible that adjustments to your medication might be discussed with the study team.

What data supports the idea that Spinal Cord Stimulation for Chronic Lower Back Pain is an effective treatment?

The available research shows that Spinal Cord Stimulation (SCS) can be effective for treating chronic lower back pain. In one study, 63.6% of patients experienced good long-term pain relief, while another 22% had fair results. Another study found that 40% of patients could control their pain with SCS alone, and an additional 12% needed occasional pain medication to achieve significant relief. These studies suggest that SCS can be a valuable option for those who haven't found relief with other treatments, especially when patients are carefully selected. However, it's important to note that some patients may experience complications, and the treatment may not work for everyone.12345

What safety data is available for spinal cord stimulation for chronic lower back pain?

Spinal cord stimulation (SCS) is generally considered safe, with a low rate of serious adverse events. Common complications include lead migration, lead breakage, infection, pain over the implant, and dural puncture. A global registry study showed a 3.5% annualized rate of device explantation, with 1.1% due to inadequate pain relief. The most common serious adverse event was implant site infection, occurring in less than 1% of cases. Despite these risks, SCS is a reversible treatment with the option for implant removal if necessary.678910

Is spinal cord stimulation a promising treatment for chronic lower back pain?

Yes, spinal cord stimulation is a promising treatment for chronic lower back pain. It has been shown to effectively relieve pain in many patients, especially those who have not benefited from other surgeries or treatments. Many patients experience significant pain relief and improved ability to perform daily activities, sometimes without needing additional pain medications.25111213

What is the purpose of this trial?

Chronic low back pain (CLBP) is a debilitating condition and costly to treat. Long-term drug treatment often fails due to habituation, breakthrough of pain, or adverse effects of drug treatment. Opioid use to manage this pain has contributed to the opioid epidemic. Spinal cord stimulators have emerged as a promising treatment and reduces reliance on drugs. However, response to spinal cord stimulation (SCS) is unpredictable. It is difficult to predict which patients will respond positively to SCS because the physiological mechanism for treatment responsiveness is unclear. Therefore, the aim of this study is to investigate how spinal cord stimulators affect functional measures in patients with CLBP, including functional MRI, neurophysiology, gait analysis, and questionnaires. The results of this study can lead to the widespread adoption of spinal cord stimulators as a safe and effective therapy for CLBP, reducing the reliance on opioids and mitigating the opioid epidemic's impact.

Research Team

Daniel C. Lu, MD, PhD - Spine Surgery ...

Daniel C Lu, MD, PhD

Principal Investigator

University of California, Los Angeles

LC

Lily Chau, MD, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

This trial is for individuals with chronic low back pain who haven't found relief through long-term medication. It's designed to see if spinal cord stimulators can help reduce pain without the need for drugs, potentially lowering opioid use.

Inclusion Criteria

I can use my legs.
I am currently receiving spinal cord stimulator treatment for my chronic low back pain.
Able to tolerate fMRI and neurophysiological evaluation
See 2 more

Exclusion Criteria

Any stimulation device and/or implant other than a spinal cord stimulator, such as a drug pump, pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS)
Life expectancy of less than 1 year
Participation in another clinical trial currently or within the past 30 days
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo spinal cord stimulation and are assessed using functional MRI, EEG, gait kinematics, and electrophysiology to evaluate the effects on chronic low back pain

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Epidural electrical spinal cord stimulator
Trial Overview The study tests how an epidural electrical spinal cord stimulator affects people with chronic lower back pain. Researchers will look at changes in brain function, nerve activity, walking patterns, and self-reported pain levels.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Responders to spinal cord stimulationExperimental Treatment1 Intervention
Patients with chronic low back pain, with \>50% pain reduction in response to spinal cord stimulation
Group II: Non-responders to spinal cord stimulationExperimental Treatment1 Intervention
Patients with chronic low back pain, with minimal to no pain reduction in response to spinal cord stimulation

Epidural electrical spinal cord stimulator is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Spinal Cord Stimulator for:
  • Chronic low back pain
  • Failed back surgery syndrome
  • Post-surgical pain
  • Arachnoiditis
  • Heart pain (angina)
  • Nerve-related pain
  • Peripheral vascular disease
  • Complex regional pain syndrome
  • Pain after amputation
  • Visceral abdominal pain and perineal pain
🇺🇸
Approved in United States as Spinal Cord Stimulator for:
  • Chronic low back pain
  • Failed back surgery syndrome
  • Post-surgical pain
  • Arachnoiditis
  • Heart pain (angina)
  • Nerve-related pain
  • Peripheral vascular disease
  • Complex regional pain syndrome
  • Pain after amputation
  • Visceral abdominal pain and perineal pain
🇨🇦
Approved in Canada as Spinal Cord Stimulator for:
  • Chronic low back pain
  • Failed back surgery syndrome
  • Post-surgical pain
  • Arachnoiditis
  • Heart pain (angina)
  • Nerve-related pain
  • Peripheral vascular disease
  • Complex regional pain syndrome
  • Pain after amputation
  • Visceral abdominal pain and perineal pain

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

Findings from Research

In a study of 77 patients with chronic low back and radicular pain, spinal cord stimulation showed good long-term efficacy in 63.6% of cases, indicating it can be an effective treatment for those with failed back surgery syndrome.
However, careful patient selection is crucial for success, as treatment failure occurred in 7.9% of cases, often due to complications or inappropriate selection, highlighting the importance of strict criteria for candidates.
[Treatment of chronic lumbago and radicular pain by spinal cord stimulation. Long-term results].Hieu, PD., Person, H., Houidi, K., et al.[2006]
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.
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 study of 32 patients with failed back syndrome, 76% of those with spinal cord stimulators reported at least 50% pain relief after one year, and 74% maintained this relief after two years, indicating long-term efficacy.
The most common complication observed was electrode migration, highlighting the need for careful patient selection and monitoring when considering spinal cord stimulation as a treatment option.
Spinal cord stimulation for the failed back syndrome.LeDoux, MS., Langford, KH.[2019]

References

[Treatment of chronic lumbago and radicular pain by spinal cord stimulation. Long-term results]. [2006]
Experience with spinal cord stimulation (SCS) in the management of chronic pain in a traumatic transverse lesion syndrome. [2019]
Spinal cord stimulation for the failed back syndrome. [2019]
[Epidural spinal cord stimulation for therapy of chronic pain. Summary of the S3 guidelines]. [2021]
Treatment of chronic pain by epidural spinal cord stimulation: a 10-year experience. [2011]
Spinal cord stimulation: Background and clinical application. [2022]
Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. [2023]
Spinal cord stimulator failure: Migration of a thoracic epidural paddle to the cervical spine. [2022]
Techniques for Safe Removal of Spinal Cord Stimulation Paddle Leads. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Present and potential use of spinal cord stimulation to control chronic pain. [2018]
Spinal Cord Stimulation: An Alternative Concept of Rehabilitation? [2017]
12.United Statespubmed.ncbi.nlm.nih.gov
Chronic stimulation via percutaneously inserted epidural electrodes. [2019]
13.United Statespubmed.ncbi.nlm.nih.gov
Technique for steering spinal cord stimulator electrode. [2012]
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