NCT07215104 A Prospective Evaluation of Spinal Cord Induced Muscle Stimulation (MuscleSCS) for the Treatment of Chronic Low Back Pain
| NCT ID | NCT07215104 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Saint Francis Hospital |
| Condition | Chronic Low Back Pain (CLBP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-10-07 |
| Primary Completion | 2026-10-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-10-07 with a primary completion date of 2026-10-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Patients with PSPS type 1 and 2 2. Patients with predominant back pain 3. Patient must be willing and able to provide written informed consent before any clinical investigation-related procedure 4. Age ≥18 y 5. 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.) \[GROUP 1\] 6. 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. \[GROUP 2\] 7. Willing and able to comply with the instructions for use, operate the study device, and comply with this clinical investigation plan Exclusion Criteria: 1. 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 2. Primary symptom of leg pain, or leg pain is greater than back pain 3. 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 4. Has widespread pain (eg, fibromyalgia) or pain in other area(s), not intended to be treated in this study (eg, neck pain, shoulder pain) 5. Patient has used a morphine equivalent daily dose of \>50 MME in the last 30 days 6. Patients with regular intake of systemic steroids (except inhaled steroids used to treat asthma) 7. Imaging (MRI, CT, x-ray) findings within the last 12 mon that contraindicate lead placement 8. Known allergic reaction to implanted materials 9. Severe scoliotic deformity (\>11◦ in thoracic or lumbar spine) 10. Patient has a history of or existing intrathecal drug pump 11. Patient with other existing implantable electrical devices, i.e. pacemakers, bladder stimulators, etc. 12. Patient has previous experience with neuromodulation devices, including a failed trial 13. BMI \>40 14. 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. 15. 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 16. Failed psychologic evaluation 17. Suspicion or evidence of untreated mental illness, substance abuse, or drug-seeking behavior 18. Patient is in current litigation for back pain/injury, or is currently receiving worker's compensation 19. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
Contact & Investigator
Timothy R Deer, MD
PRINCIPAL INVESTIGATOR
WVUM/Thomas Hospitals (Saint Francis Hospital) Spine and Nerve Center
Frequently Asked Questions
Who can join the NCT07215104 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Low Back Pain (CLBP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07215104 currently recruiting?
Yes, NCT07215104 is actively recruiting participants. Contact the research team at amelia.young3@wvumedicine.org for enrollment information.
Where is the NCT07215104 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT07215104 clinical trial?
NCT07215104 is sponsored by Saint Francis Hospital. The principal investigator is Timothy R Deer, MD at WVUM/Thomas Hospitals (Saint Francis Hospital) Spine and Nerve Center. The trial plans to enroll 30 participants.