[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07215104":3,"trial-entities:NCT07215104":86,"trial-summary:NCT07215104":90},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":32,"secondary_outcomes":52,"sex":53,"minimum_age":54,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":55,"std_ages":59,"locations":62,"central_contacts":78,"overall_officials":80,"references":84,"see_also_links":85},"NCT07215104","MuscleSCS Study V2.0","A Prospective Evaluation of Spinal Cord Induced Muscle Stimulation (MuscleSCS) for the Treatment of Chronic Low Back Pain","RECRUITING","2027-01-01","2025-10","2025-10-10","2025-10-07","Saint Francis Hospital","OTHER",false,"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.",null,[18],"Chronic Low Back Pain (CLBP)",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},30,"ESTIMATED",[28],{"type":29,"name":30,"description":31},"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).\n\nGroup 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.",[33,37,40,43,46,49],{"measure":34,"description":35,"timeFrame":36},"NRS","Numerical Rating Scale for Pain","Enrollment to End of Study (3mo Visit)",{"measure":38,"description":39,"timeFrame":36},"ODI","Oswestry Disability Index",{"measure":41,"description":42,"timeFrame":36},"EQ5D-5L","5 Dimension Health Related Quality of Life Questionnaire",{"measure":44,"description":45,"timeFrame":36},"PDI","Pain Disability Index",{"measure":47,"description":48,"timeFrame":36},"PCS","Pain Catastrophizing Scale",{"measure":50,"description":51,"timeFrame":36},"PGIC","Patient Global Impression of Change",[],"ALL","18 Years",{"inclusion":56,"exclusion":57,"raw_text":58},[],[],"Inclusion Criteria:\n\n1. Patients with PSPS type 1 and 2\n2. Patients with predominant back pain\n3. Patient must be willing and able to provide written informed consent before any clinical investigation-related procedure\n4. Age ≥18 y\n5. 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.\n\n   (Only responders to that therapy should be included, not patients who have not responded to their therapy so far.) \\[GROUP 1\\]\n6. 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\\]\n7. Willing and able to comply with the instructions for use, operate the study device, and comply with this clinical investigation plan\n\nExclusion Criteria:\n\n1. 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\n2. Primary symptom of leg pain, or leg pain is greater than back pain\n3. 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\n4. Has widespread pain (eg, fibromyalgia) or pain in other area(s), not intended to be treated in this study (eg, neck pain, shoulder pain)\n5. Patient has used a morphine equivalent daily dose of \\>50 MME in the last 30 days\n6. Patients with regular intake of systemic steroids (except inhaled steroids used to treat asthma)\n7. Imaging (MRI, CT, x-ray) findings within the last 12 mon that contraindicate lead placement\n8. Known allergic reaction to implanted materials\n9. Severe scoliotic deformity (\\>11◦ in thoracic or lumbar spine)\n10. Patient has a history of or existing intrathecal drug pump\n11. Patient with other existing implantable electrical devices, i.e. pacemakers, bladder stimulators, etc.\n12. Patient has previous experience with neuromodulation devices, including a failed trial\n13. BMI \\>40\n14. Patient is enrolled, or intends to participate, in another clinical drug and\u002For device study or registry that may interfere with the results of this study.\n15. 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\n16. Failed psychologic evaluation\n17. Suspicion or evidence of untreated mental illness, substance abuse, or drug-seeking behavior\n18. Patient is in current litigation for back pain\u002Finjury, or is currently receiving worker's compensation\n19. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.",[60,61],"ADULT","OLDER_ADULT",[63],{"facility":64,"status":7,"city":65,"state":66,"zip":67,"country":68,"contacts":69,"geoPoint":75},"WVUM\u002FThomas Hospitals (Saint Francis Hospital) Spine and Nerve Center","Charleston","West Virginia","25301","United States",[70],{"name":71,"role":72,"phone":73,"email":74},"Amy Young, RN, BSN, DMPNA","CONTACT","304-347-6144","amelia.young3@wvumedicine.org",{"lat":76,"lon":77},38.34982,-81.63262,[79],{"name":71,"role":72,"phone":73,"email":74},[81],{"name":82,"affiliation":64,"role":83},"Timothy R Deer, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":87,"biomarkers":89},[88],"Chronic low back pain",[],{"nct_id":4,"found":91,"summary":92,"prompt_version":102},true,{"design":93,"status":94,"heading":95,"summary":96,"follow_up":97,"word_count":98,"commitments":99,"compensation":100,"drugs_mentioned":101},"This is a multi-center study that plans to include 30 participants. It is designed to compare the safety and effectiveness of MuscleSCS.","completed","Spinal Cord Induced Muscle Stimulation (MuscleSCS) for Chronic Low Back Pain","This study is looking at a treatment called MuscleSCS (spinal cord induced muscle stimulation) for people with long-lasting low back pain. Researchers want to see how safe and effective MuscleSCS is. You might be able to join if you are at least 18 years old, have specific types of back pain (PSPS type 1 and 2), and already have a spinal cord stimulator (SCS) system with BurstDR stimulation that has given you more than 50% pain relief for over six months. The study will measure success by looking at your pain levels (NRS), how much your pain affects your daily life (ODI), and your overall quality of life (EQ5D-5L) from when you start until three months later. The current status of this study is unclear.","Participants will be followed from enrollment until the end of the study, which is at the 3-month visit.",125,"Not specified in the trial record.","Not stated in the trial record.",[30],"v2"]