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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how spinal cord stimulators (also known as epidural electrical spinal cord stimulators) can help people with chronic lower back pain. The goal is to determine if this treatment can reduce pain and lessen the need for pain-relieving drugs, especially opioids. Researchers will examine brain and body reactions to the treatment using scans, movement tests, and surveys. Suitable participants should already have a spinal cord stimulator and experience ongoing lower back pain most days for the past six months. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve pain management for many.

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

Research has shown that spinal cord stimulation (SCS) is generally well-tolerated and can safely manage chronic back pain. For instance, a study in Europe found that SCS reduced pain without causing serious side effects. Another review confirmed that SCS is a promising and less invasive treatment for individuals who haven't found relief from other methods.

While SCS is considered safe, individual experiences can vary. Some people might feel mild discomfort or temporary tingling where the device is placed. However, these issues are usually manageable and resolve over time. Overall, current evidence supports SCS as a safe alternative for those seeking relief from chronic back pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for chronic lower back pain, like physical therapy, medications, and surgery, focus on managing symptoms rather than addressing the pain at its source. However, spinal cord stimulation is unique because it uses an epidural electrical stimulator to directly target and modulate pain signals in the spinal cord. This approach can potentially provide significant pain relief by altering the way pain is perceived, offering hope for those who haven't found success with other treatments. Researchers are excited because this method could lead to more personalized pain management, especially for patients who experience over 50% pain reduction with this intervention.

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

Research has shown that spinal cord stimulation can greatly reduce pain for many people with long-term lower back pain. In one study, more than 80% of participants reported a significant drop in their pain levels. Another study found that 77% of patients experienced at least a 50% decrease in pain. This trial will include participants who respond well to spinal cord stimulation, experiencing significant pain reduction, as well as those who do not notice any improvement. This treatment is considered safe, involves only a minor procedure (not major surgery), and can be undone if needed. However, it doesn't work for everyone, and some people might not notice any improvement. ^{2 4 5 6 7}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12321793/

The effectiveness of spinal cord stimulation combined with ... Spinal cord stimulation alone led to significant pain reductions, with responder rates above 80% and average decreases of 5–6 cm on pain scales.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6391880/

Spinal Cord Stimulation: Clinical Efficacy and Potential ... A European prospective study reported a high trial-to-implant ratio (88%) with HF10 and outstanding pain reduction, with 77% of patients reporting ≥50% pain ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1094715921064321

Systematic Literature Review of Spinal Cord Stimulation in ... Findings suggest that SCS is a promising, safe, minimally invasive, and reversible alternative option for managing chronic back pain in patients who have not ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2797419

Effect of Spinal Cord Burst Stimulation vs Placebo ... Spinal cord burst stimulation, compared with placebo stimulation, resulted in no significant difference in back pain–related disability.

5. neurolrespract.biomedcentral.com neurolrespract.biomedcentral.com/articles/10.1186/s42466-023-00241-z

Beyond treatment of chronic pain: a scoping review about ... Epidural electrical epinal cord stimulation (ESCS) is an established therapeutic option in various chronic pain conditions.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK553154/

Spinal Cord Stimulation - StatPearls - NCBI Bookshelf - NIH This technique uses pulsed electrical energy near the spinal cord to manage pain. This activity reviews the indications, contraindications, equipment, ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf3/P030017S275B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The results of the review support the effectiveness of SCS therapy in treating patients who suffer from chronic, intractable pain of the trunk and/or limbs, ...