NCT07215104 · Saint Francis Hospital
A Prospective Evaluation of Spinal Cord Induced Muscle Stimulation (MuscleSCS) for the Treatment of Chronic Low Back Pain
(MuscleSCS)
What this study is about
This study is a forward-looking, multi-center study designed to compare the safety and effectiveness of spinal cord induced muscle stimulation (MuscleSCS) for the treatment of chronic low back pain.
View original scientific description
This study is a prospective, multi-center study designed to compare the safety and efficacy of spinal cord induced muscle stimulation (MuscleSCS) for the treatment of chronic low back pain.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients with PSPS type 1 and 2
- Patients with predominant back pain
- Patient must be willing and able to provide written informed consent before any clinical investigation-related procedure
- Patients with SCS(BurstDR) stimulation in situ for more than 6 month and \>50% pain relief. Patients have to be satisfied with their existing SCS therapy and predominantly use a BurstDR stimulation program. (Only responders to that therapy should be included, not patients who have not responded to their therapy so far.) \[GROUP 1\]
- Low back pain baseline score of ≥6 on NRS before spinal cord stimulation therapy and a MCID (Minimal clinically important difference) of \>50% with SCS(BurstDRTM) trial stimulation. \[GROUP 2\]
- Willing and able to comply with the instructions for use, operate the study device, and comply with this clinical investigation plan
Exclusion criteria
- Pathology seen on imaging tests obtained within the past 12 month that is clearly identified and is likely the cause of the CLBP, that can be addressed with surgery
- Primary symptom of leg pain, or leg pain is greater than back pain
- Back pain is due to any of the following: vascular causes (eg, aortic aneurysm), spinal infection (eg, osteomyelitis), inflammation or damage to the spinal cord (eg, arachnoiditis or syringomyelia), tumor or spinal metastases
- Has widespread pain (eg, fibromyalgia) or pain in other area(s), not intended to be treated in this study (eg, neck pain, shoulder pain)
- Patient has used a morphine equivalent daily dose of \>50 MME in the last 30 days
- Patients with regular intake of systemic steroids (except inhaled steroids used to treat asthma)
- Imaging (MRI, CT, x-ray) findings within the last 12 mon that contraindicate lead placement
- Known allergic reaction to implanted materials
- Severe scoliotic deformity (\>11◦ in thoracic or lumbar spine)
- Patient has a history of or existing intrathecal drug pump
- Patient with other existing implantable electrical devices, i.e. pacemakers, bladder stimulators, etc.
- Patient has previous experience with neuromodulation devices, including a failed trial
- Patient is enrolled, or intends to participate, in another clinical drug and/or device study or registry that may interfere with the results of this study.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychologic conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results
- Failed psychologic evaluation
- Suspicion or evidence of untreated mental illness, substance abuse, or drug-seeking behavior
- Patient is in current litigation for back pain/injury, or is currently receiving worker's compensation
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
Where
- Charleston, West Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 10, 2025 · Source of record for eligibility and locations