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New treatment option for Chronic Low Back Pain (CLBP)
Official title A Prospective Evaluation of Spinal Cord Induced Muscle Stimulation (MuscleSCS) for the Treatment of Chronic Low Back Pain
ClinicalTrials.gov ID: NCT07215104
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join 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...
- 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...
- 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)
See the full eligibility criteria
- 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...
- 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
- 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...
- 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...
- 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 people and those who plan pregnancy during the clinical investigation follow-up period.
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, West Virginia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, West Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.