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
12 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
Researchers are evaluating the safety and effectiveness of a device called MuscleSCS, which uses spinal cord induced muscle stimulation to treat people with chronic low back pain. This prospective, multi-center study focuses on adults with this condition, including those who already have spinal cord stimulation devices and those who are candidates for such treatment. The study aims to better understand how this stimulation affects pain relief and quality of life. Participants will be divided into two groups: one group consists of patients who have had a spinal cord stimulation system implanted for more than six months and have experienced significant pain relief; the other group includes patients who are candidates for a trial and potential permanent spinal cord stimulation. The study will monitor the use and effects of MuscleSCS over the course of the trial. Throughout the study, participants will be assessed for changes in pain intensity, disability, quality of life, and psychological factors using various measures such as the Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), EQ5D-5L, Pain Disability Index (PDI), Pain Catastrophizing Scale (PCS), and Patient Global Impression of Change (PGIC). These evaluations will occur from enrollment until three months after study completion, with researchers closely following participants' progress and safety.
CONDITIONS
Brief 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 post-surgical persistent pain syndrome (PSPS) type 1 or 2
- Patients with predominant back pain
- Willing and able to provide written informed consent before any study procedure
- Aged 18 years or older
- For Group 1: patients with spinal cord stimulation (BurstDR) implanted for more than 6 months, experiencing over 50% pain relief and satisfied with their therapy
- For Group 2: patients with a baseline low back pain score of 6 or higher on the Numeric Rating Scale before spinal cord stimulation, and a minimal clinically important difference greater than 50% with trial stimulation
- Willing and able to follow study device instructions and comply with the investigation plan
You will not qualify if you...
- Imaging within the past 12 months showing pathology likely causing chronic low back pain that can be treated surgically
- Primary symptom of leg pain, or leg pain greater than back pain
- Back pain due to vascular causes, spinal infection, inflammation or spinal cord damage, tumor, or spinal metastases
- Widespread pain such as fibromyalgia or pain in other areas not targeted by the study
- Use of morphine equivalent daily dose over 50 mg in the last 30 days
- Regular use of systemic steroids (except inhaled steroids for asthma)
- Imaging findings contraindicating lead placement
- Known allergy to implanted materials
- Severe scoliotic deformity over 11 degrees in thoracic or lumbar spine
- History of or existing intrathecal drug pump
- Presence of other implantable electrical devices
- Previous experience with neuromodulation devices including failed trials
- Body mass index over 40
- Enrollment or intent to participate in other clinical drug or device studies that may interfere
- Other anatomical, medical, social, or psychological conditions limiting participation or follow-up
- Failed psychological evaluation
- Untreated mental illness, substance abuse, or drug-seeking behavior
- Current litigation or worker's compensation for back pain or injury
- Pregnant, nursing, or planning pregnancy during the study follow-up period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants receive spinal cord induced muscle stimulation as part of the study intervention.
1 baseline visit and 1 follow-up visit
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
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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