Actively Recruiting
A Prospective Evaluation of Spinal Cord Induced Muscle Stimulation (MuscleSCS) for the Treatment of Chronic Low Back Pain
Led by Saint Francis Hospital · Updated on 2025-10-10
30
Participants Needed
1
Research Sites
64 weeks
Total Duration
On this page
Sponsors
S
Saint Francis Hospital
Lead Sponsor
A
Abbott Medical Devices
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Prospective Evaluation of Spinal Cord Induced Muscle Stimulation (MuscleSCS) for the Treatment of Chronic Low Back Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with persistent spinal pain syndrome (PSPS) type 1 or 2
- Predominant back pain present
- Able and willing to provide written informed consent
- Age 18 years or older
- For Group 1: Patients with SCS (BurstDR) implanted for more than 6 months with over 50% pain relief and satisfaction using BurstDR stimulation
- For Group 2: Patients with baseline low back pain score of 6 or higher on NRS before SCS therapy and over 50% improvement during SCS trial
- Willing and able to comply with device instructions and study procedures
You will not qualify if you...
- Imaging within past 12 months shows treatable cause of back pain requiring surgery
- Primary symptom is leg pain or leg pain greater than back pain
- Back pain caused by vascular issues, spinal infection, inflammation, tumor, or metastases
- Widespread pain conditions like fibromyalgia or pain outside study focus areas
- Use of morphine equivalent doses over 50 MME daily in last 30 days
- Regular use of systemic steroids (except inhaled for asthma)
- Imaging findings contraindicating lead placement in last 12 months
- Known allergy to implanted materials
- Severe scoliosis deformity greater than 11 degrees in thoracic or lumbar spine
- History of or current intrathecal drug pump
- Presence of other implantable electrical devices such as pacemakers or bladder stimulators
- Previous neuromodulation device use including failed trial
- Body mass index over 40
- Participation in other clinical studies that may interfere
- Other medical, social, or psychological conditions limiting participation
- Failed psychological evaluation
- Untreated mental illness, substance abuse, or drug-seeking behavior
- Current litigation or worker's compensation related to back pain
- Pregnant, nursing, or planning pregnancy during study follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
WVUM/Thomas Hospitals (Saint Francis Hospital) Spine and Nerve Center
Charleston, West Virginia, United States, 25301
Actively Recruiting
Research Team
A
Amy Young, RN, BSN, DMPNA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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