Muscle Stimulation for Chronic Lower Back Pain

(MuscleSCS Trial)

Overseen By Amy Young, RN, BSN, DMPNA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Saint Francis Hospital

Must be taking: SCS BurstDR

Must not be taking: Systemic steroids, Morphine

Disqualifiers: Leg pain, Fibromyalgia, BMI >40, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MuscleSCS to determine its safety and effectiveness in reducing chronic lower back pain. It employs a special type of muscle stimulation through the spinal cord. Individuals who have used a similar therapy, BurstDR, and experienced at least a 50% reduction in pain might be suitable candidates. The trial excludes those whose back pain results from clear surgical issues or who experience more leg pain than back pain. Participants must be willing to follow study instructions and use the study device. As an unphased trial, this study provides an opportunity to explore innovative treatment options for chronic lower back pain.

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

The trial information does not specify if you need to stop taking your current medications. However, if you are using more than 50 MME of morphine daily or regularly taking systemic steroids, you may not be eligible to participate.

What prior data suggests that spinal cord induced muscle stimulation is safe for treating chronic lower back pain?

Research has shown that spinal cord stimulation (SCS) is generally safe for people with chronic back pain. Studies have found that SCS helps manage pain by sending electrical signals to the spinal cord, and most patients tolerate this treatment well.

One review found that SCS has a good safety record, with serious side effects being rare. Another study showed that the long-term effects of SCS were positive for people with severe pain.

Overall, while SCS carries some risks, it is usually considered safe for treating chronic back pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Spinal Cord Induced Muscle Stimulation (MuscleSCS) is unique because it directly targets muscle activation through spinal cord stimulation, which is different from traditional treatments for chronic lower back pain like physical therapy, medication, or surgery. While current options often focus on pain relief or spinal adjustments, MuscleSCS aims to strengthen the muscles supporting the spine, potentially addressing the root cause of the pain. Researchers are excited about this treatment because it promises a non-invasive approach that could offer more sustainable relief and improve quality of life for patients with chronic lower back pain.

What evidence suggests that spinal cord induced muscle stimulation is effective for chronic low back pain?

Research shows that spinal cord stimulation can significantly reduce pain for people with chronic low back pain. Studies have found that over 80% of patients experience a noticeable decrease in pain, with improvements of 5-6 centimeters on pain scales. However, other research suggests that spinal cord stimulation might not surpass a placebo in improving back or leg pain, function, or quality of life. While some patients have experienced long-term benefits, the evidence remains mixed. Overall, the treatment has helped some people, but results can vary. ^{1 6 7 8 9}

Who Is on the Research Team?

Timothy R Deer, MD

Principal Investigator

WVUM/Thomas Hospitals (Saint Francis Hospital) Spine and Nerve Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic low back pain who've had successful spinal cord stimulation (SCS) therapy for at least 6 months. They must be able to operate the study device and follow the plan, without severe spine deformity, steroid use, or conflicting implants. Pregnant women and those with certain medical conditions or in litigation for back pain are excluded.

Inclusion Criteria

Patient must be willing and able to provide written informed consent before any clinical investigation-related procedure

Patients with PSPS type 1 and 2

My main symptom is back pain.

Exclusion Criteria

I have a severe curve in my spine.

Imaging (MRI, CT, x-ray) findings within the last 12 months that contraindicate lead placement

Known allergic reaction to implanted materials

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive spinal cord induced muscle stimulation (MuscleSCS) for the treatment of chronic low back pain

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Spinal Cord Induced Muscle Stimulation (MuscleSCS)

Trial Overview The study compares a new treatment called MuscleSCS against standard BurstDR SCS therapy in two groups of patients already responding well to SCS. It's designed to see if MuscleSCS can further reduce chronic lower back pain more effectively and safely than current treatments.

Who Is Running the Clinical Trial?

Saint Francis Hospital

Lead Sponsor

Trials

3

Recruited

40+

Abbott Medical Devices

Industry Sponsor

Trials

659

Recruited

420,000+

Founded

1888

Headquarters

Abbott Park, Illinois, USA

Known For

Medical Devices Innovation

Top Products

FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs

Dr. Etahn Korngold

Abbott Medical Devices

Chief Medical Officer

Medical training at Harvard Medical School and Massachusetts General Hospital

Robert B. Ford

Abbott Medical Devices

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07215104

A Prospective Evaluation of Spinal Cord Induced Muscle ... This study is a prospective, multi-center study designed to compare the safety and efficacy of spinal cord induced muscle stimulation (MuscleSCS) ...

2. 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.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1094715921063868

Long-Term Outcomes of Restorative Neurostimulation in ... At two years, 76% of participants experienced substantial, clinically meaningful improvements in pain, disability, or both. These results provide evidence of ...

4. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD014789.pub2/full

Spinal cord stimulation for low back pain - Traeger, AC - 2023 There was moderate‐certainty evidence that SCS probably does not improve back or leg pain, function, or quality of life compared with placebo.

5. 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9990744/

Spinal cord stimulation for low back pain - PubMed Central - NIH Spinal cord stimulation (SCS) is a surgical intervention used to treat persistent low back pain. SCS is thought to modulate pain by sending electrical signals.

7. stjudepaincenters.com stjudepaincenters.com/wp-content/uploads/2018/12/Safety-efficacy-spinal-cord-stimulation-chronic-pain-20-year-review-Cameron-1.pdf

Safety & Efficacy of Spinal Cord Stimulation for Chronic Pain Based on the literature review, the author found that SCS had a positive, symptomatic, long-term effect in cases of refractory angina pain, severe ischemic limb ...

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

Spinal Cord Stimulation for Chronic Back Pain w/o Surgery Findings from this systematic review suggest SCS has an acceptable safety profile in patients with chronic back pain without prior surgery and is associated ...

9. thejns.org thejns.org/spine/view/journals/j-neurosurg-spine/100/3/article-p254.xml

Safety and efficacy of spinal cord stimulation for the treatment ... The authors examined the effects of SCS on patients with chronic back pain. They concluded that SCS did appear to affect pain; however, this effect was modest.