Recruiting NCT07215104
A Prospective Evaluation of Spinal Cord Induced Muscle Stimulation (MuscleSCS) for the Treatment of Chronic Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MuscleSCS.
- Who it may be relevant to
- Registry conditions: Chronic Low Back Pain (CLBP). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device MuscleSCS
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
Primary outcome measures
- NRS [Time frame: Enrollment to End of Study (3mo Visit)]
- ODI [Time frame: Enrollment to End of Study (3mo Visit)]
- EQ5D-5L [Time frame: Enrollment to End of Study (3mo Visit)]
- PDI [Time frame: Enrollment to End of Study (3mo Visit)]
- PCS [Time frame: Enrollment to End of Study (3mo Visit)]
- PGIC [Time frame: Enrollment to End of Study (3mo Visit)]
Eligibility criteria
Inclusion 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 responders to that therapy should be included, not patients who have not responded to their therapy so far.) \[GROUP 1\]
- 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
Exclusion criteria
- 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 metastases
- 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 or to comply with follow-up requirements of the clinical investigation results
- 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 subjects and those who plan pregnancy during the clinical investigation follow-up period.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- WVUM/Thomas Hospitals (Saint Francis Hospital) Spine and Nerve Center — Charleston
Identifiers
NCT: NCT07215104 · MuscleSCS Study V2.0