Spinal Cord Stimulation for Chronic Lower Back Pain
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
Principal Investigator
University of California, Los Angeles
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Epidural electrical spinal cord stimulator
Epidural electrical spinal cord stimulator is already approved in European Union, United States, Canada for the following indications:
- 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
- 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
- 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