A Prospective Evaluation of Spinal Cord Induced Muscle Stimulation (MuscleSCS) for the Treatment of Chronic Low Back Pain

Recruiting now · Not applicable

Conditions studied: Chronic Low Back Pain (CLBP)

In brief

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.

Key facts

Study ID

NCT07215104

Run by

Saint Francis Hospital

People needed

30

Starts

2025-10-07

Expected to finish

2027-01-01

Last updated by the study team

2025-10-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Age ≥18 y
• 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

You may not qualify if…

• 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
• BMI >40
• 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 it is running

• WVUM/Thomas Hospitals (Saint Francis Hospital) Spine and Nerve Center — Charleston, West Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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