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

Part of paid clinical trials in Charleston, West Virginia.

Sponsor
Saint Francis Hospital
Study ID
NCT07215104
Status
Recruiting

Conditions

  • Chronic Low Back Pain (CLBP)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MuscleSCS — DEVICE
    The population for this study will include two specific groups of the same pain population. Group one is the Pre-existing SCS Group, these are pain patients with chronic back pain, and who have been implanted with an SCS system with a percutaneous lead or a paddle lead and BurstDRTM IPG for more than 6 month and having success with their BurstSCS stimulation (\>50% pain relief). Group two is the Trial SCS Group, these are pain patients with chronic back pain, and who have been determined to be candidates for trial and potential permanent SCS with a percutaneous lead or a paddle lead and BurstDRTM IPG.

Study Details

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 Dates

Start date
Oct 7, 2025
Status verified
Oct 2025
Primary completion
Oct 7, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

NRS [ Time Frame: Enrollment to End of Study (3mo Visit) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
WVUM/Thomas Hospitals (Saint Francis Hospital) Spine and Nerve CenterCharlestonWest Virginia25301
Amy Young, RN, BSN, DMPNA
304-347-6144

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