Spinal Cord Stimulation for Chronic Lower Back Pain

Overseen By Daniel C Lu, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must be taking: Spinal cord stimulators

Must not be taking: Narcotics, Alcohol

Disqualifiers: Psychiatric disorder, Substance abuse, 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: Unknown

Duration: 1 year

20 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{2 5 11 12 13}

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

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

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

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

Group I: Responders to spinal cord stimulation Experimental Treatment 1 Intervention

Patients with chronic low back pain, with \>50% pain reduction in response to spinal cord stimulation

Group II: Non-responders to spinal cord stimulation Experimental Treatment 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for the failed back syndrome. LeDoux, MS., Langford, KH.[2019]

Epidural spinal cord stimulation (SCS) is an effective treatment for neuropathic pain conditions like complex regional pain syndrome and chronic radiculopathy, particularly after conservative therapies have failed.

Successful use of epidural SCS requires careful patient selection and should be part of a comprehensive treatment plan, implemented only in specialized centers to manage potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Epidural spinal cord stimulation for therapy of chronic pain. Summary of the S3 guidelines]. Tronnier, V., Baron, R., Birklein, F., et al.[2021]

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]

Spinal cord stimulation (SCS) is an effective surgical treatment for chronic neuropathic pain, with success rates ranging from 50-75% when performed by experienced practitioners, and is indicated for conditions like complex regional pain syndrome and diabetic neuropathy.

The procedure involves implanting leads in the spinal canal to deliver electrical currents, but it carries risks such as lead migration and infection, and its exact mechanisms of action remain only partially understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation: Background and clinical application. Meier, K.[2022]

In a global study involving 1881 participants, spinal cord stimulation (SCS) demonstrated a high level of safety, with a low annualized device explant rate of 3.5% and only 1.1% due to inadequate pain relief.

The most common serious adverse event was implant site infection, occurring in less than 1% of cases, indicating that SCS is generally safe for chronic pain management over a follow-up period of up to 3 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. Rauck, RL., Loudermilk, E., Thomson, SJ., et al.[2023]

A case study of a 53-year-old male revealed that a spinal cord stimulator placed at the T10-T11 level migrated cranially to the cervical spine, causing arm paresthesias post-surgery.

The migration was successfully addressed by replacing the paddle at the original site and securing the leads with a new cranial plating system, resulting in a positive outcome for the patient without further complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulator failure: Migration of a thoracic epidural paddle to the cervical spine. Travers, SS., Norregaard, TV.[2022]

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]

Spinal cord stimulation has been shown to be more effective than conservative medical management and reoperation for treating pain from failed back surgery syndrome, and it also provides clinical benefits for conditions like complex regional pain syndrome and refractory angina pectoris.

Emerging technologies in spinal cord stimulation, such as high frequency stimulation and dorsal root ganglion stimulation, are being developed to address challenging pain conditions, with preliminary results showing promise, although further large randomized control trials are necessary to confirm their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Present and potential use of spinal cord stimulation to control chronic pain. Song, JJ., Popescu, A., Bell, RL.[2018]

In a study of 10 patients with chronic low back and leg pain who had previously undergone surgery, spinal cord stimulation combined with medication and physical therapy led to significant reductions in pain, with back pain scores decreasing from 7.5 to 2.9 and leg pain scores from 8.2 to 3.0 after 6 months.

The treatment also improved patients' quality of life, as indicated by a decrease in the Oswestry Disability Index (ODI) score from a median of 75.7% to 32.7%, demonstrating its efficacy for those with failed back surgery syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation: An Alternative Concept of Rehabilitation? Giugno, A., Gulì, C., Basile, L., et al.[2017]

In a study of 31 patients with intractable pain from conditions like chronic low back syndrome and cancer, spinal cord electrical stimulation significantly relieved pain in 23 to 26 patients after an average of 6 months of treatment.

Patients reported improved ability to perform daily activities and many were able to eliminate their use of pain medications, indicating the efficacy of this treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic stimulation via percutaneously inserted epidural electrodes. North, RB., Fischell, TA., Long, DM.[2019]

A new surgical technique using a malleable suture retrieval snare allows for precise positioning of spinal cord stimulator electrodes, improving stimulation coverage for chronic pain management in 15 patients.

This method has significantly reduced the time for electrode placement and repositioning, decreased patient discomfort, and has shown no adverse effects, indicating its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technique for steering spinal cord stimulator electrode. MacDonald, JD., Fisher, KJ.[2012]

References

1. France pubmed.ncbi.nlm.nih.gov

[Treatment of chronic lumbago and radicular pain by spinal cord stimulation. Long-term results]. [2006]

2. Germany pubmed.ncbi.nlm.nih.gov

Experience with spinal cord stimulation (SCS) in the management of chronic pain in a traumatic transverse lesion syndrome. [2019]

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

Spinal cord stimulation for the failed back syndrome. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

[Epidural spinal cord stimulation for therapy of chronic pain. Summary of the S3 guidelines]. [2021]

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

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

6. Germany pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation: Background and clinical application. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. [2023]

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

Spinal cord stimulator failure: Migration of a thoracic epidural paddle to the cervical spine. [2022]

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

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

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

Present and potential use of spinal cord stimulation to control chronic pain. [2018]

11. Austria pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation: An Alternative Concept of Rehabilitation? [2017]

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

Chronic stimulation via percutaneously inserted epidural electrodes. [2019]

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

Technique for steering spinal cord stimulator electrode. [2012]