[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07433634":3,"trial-entities:NCT07433634":116,"trial-summary:NCT07433634":121},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":29,"primary_purpose":15,"phases":30,"enrollment_info":31,"interventions":34,"primary_outcomes":40,"secondary_outcomes":45,"sex":58,"minimum_age":59,"maximum_age":15,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":74,"locations":77,"central_contacts":101,"overall_officials":111,"references":114,"see_also_links":115},"NCT07433634","2000040858","Time to BBVNA Relief","Temporal Trends and Predictors of Clinical Response Following Basivertebral Nerve (BVN) Ablation: A Prospective Observational Cohort Study","RECRUITING","2026-10","2026-02","2026-03-03","2024-04-19","Yale University","OTHER",null,"Basivertebral nerve ablation (BVNA) is a minimally invasive procedure approved for vertebrogenic low back pain. While early studies support its efficacy, real-world evidence is still evolving, particularly regarding the trajectory of pain relief and functional improvement over time, and predictors of clinical response. This study aims to evaluate clinical outcomes longitudinally following BVNA and identify baseline predictors of response.","Primary Objective:\n\n• To determine the proportion of patients achieving clinical response (defined as ≥50% reduction in VAS or ≥15-point improvement in ODI) following BVNA.\n\nSecondary Objectives:\n\n* To assess changes in PROMIS-7, PAVS, and other patient-reported outcomes.\n* To determine the incidence of further interventions such as epidural steroid injections (ESIs) or surgeries.\n* To evaluate temporal trends in response and adverse events. A total of 11 visits inclusive of follow up visits with schedule for study intervals. 1 baseline visit, 8 virtual\u002F phone weekly visits, 1 3-month virtual visit , 1 6-month , 1 12-month and 1 24-month visit.",[19,20,21],"Low Back Pain","Vertebrogenic Pain Syndrome","Basivertebral Nerve Ablation",[23,24,25,26,27,28],"Pain relief trajectory","Basivertebral nerve ablation","Vertebrogenic low back pain,","Responder phenotypes","Clinical Outcomes","Radiofrequency Ablation","OBSERVATIONAL",[],{"count":32,"type":33},200,"ESTIMATED",[35],{"type":36,"name":24,"description":37,"otherNames":38},"PROCEDURE","Participants underwent fluoroscopically guided intraosseous basivertebral nerve ablation (BVNA) using the Intracept® System (Boston Scientific, MA, USA) targeting MRI-confirmed Modic type 1 or 2 vertebral endplate changes. Procedures were performed under general anesthesia via a transpedicular or parapedicular approach with biplanar fluoroscopic confirmation of probe placement at the basivertebral foramen (30-50% vertebral body depth, midline AP position). Thermal radiofrequency ablation was delivered using either 75°C for 7 minutes (targeted lesion) or 85°C for 15 minutes (expanded lesion), selected based on intraoperative probe proximity to the intended target to optimize nerve capture. Only levels with imaging-confirmed Modic changes were treated. Weekly patient-reported outcomes were collected for 8, 12, 24 , 48 through 98 weeks.",[39],"Basivertebral Nerve Radiofrequency Ablation",[41],{"measure":42,"description":43,"timeFrame":44},"Percentage of participants achieving clinical response","Clinical response defined as a ≥50% reduction in pain intensity from baseline as measured by the Visual Analog Scale (VAS) or a ≥15-point improvement in the Oswestry Disability Index (ODI) score","2 years",[46,49,52,55],{"measure":47,"description":48,"timeFrame":44},"Change in PROMIS-7 Global Health Score","7-item, self-report, or parent-proxy tool designed to assess overall physical, mental, and social health using a 5-point Likert scale., score range 20-80. It generates a T-score, where 50 is the U.S. population average and 10 is the standard deviation. Higher scores indicate better overall health.",{"measure":50,"description":51,"timeFrame":44},"Percentage of participants with incresed physical activity assessed using Physical Activity Vital Sign (PAVS)","2-question screening tool used in clinical settings to assess if adults meet the recommended 150+ minutes of weekly moderate-to-vigorous physical activity. Calculate the total weekly minutes of exercise by multiplying #1 times #2.",{"measure":53,"description":54,"timeFrame":44},"Incidence of spine-related interventions","Incidence of further spine-related interventions (e.g., epidural steroid injections, radiofrequency ablation, or spine surgery) post-BVN ablation.",{"measure":56,"description":57,"timeFrame":44},"Patient Global Impression of Change (PGIC) score","Self-report 7-point scale measuring a patient's belief regarding the effectiveness of a treatment with higher scores indicating a better outcome. Score range 1-7.","ALL","18 Years",false,{"inclusion":62,"exclusion":67,"raw_text":73},[63,64,65,66],"Diagnosis of chronic axial low back pain with vertebrogenic features","Scheduled for BVN ablation","Able to provide informed consent","Capable of participating in weekly virtual\u002Ftelephone follow-up for 8 weeks and in- person or remote follow-up at 3 and 6 months through 2 years",[68,69,70,71,72],"Prior spinal neuromodulation therapy (e.g., spinal cord stimulation or intrathecal pump) within the past 6 months","Active substance use disorder or uncontrolled psychiatric illness that may interfere with participation","Cognitive impairment limiting ability to complete surveys or provide informed consent","Pregnancy","Incarceration or current status as a prisoner","Inclusion Criteria:\n\n* Diagnosis of chronic axial low back pain with vertebrogenic features\n* Scheduled for BVN ablation\n* Able to provide informed consent\n* Capable of participating in weekly virtual\u002Ftelephone follow-up for 8 weeks and in- person or remote follow-up at 3 and 6 months through 2 years\n\nExclusion Criteria:\n\n* Prior spinal neuromodulation therapy (e.g., spinal cord stimulation or intrathecal pump) within the past 6 months\n* Active substance use disorder or uncontrolled psychiatric illness that may interfere with participation\n* Cognitive impairment limiting ability to complete surveys or provide informed consent\n* Pregnancy\n* Incarceration or current status as a prisoner",[75,76],"ADULT","OLDER_ADULT",[78,87,94],{"facility":79,"status":8,"city":80,"state":81,"zip":82,"country":83,"geoPoint":84},"Yale Spine and Pain Center - Guilford","Guilford","Connecticut","06437","United States",{"lat":85,"lon":86},41.28899,-72.68176,{"facility":88,"status":8,"city":89,"state":81,"zip":90,"country":83,"geoPoint":91},"Yale Pain Management Center - New Haven","New Haven","06519",{"lat":92,"lon":93},41.30815,-72.92816,{"facility":95,"status":8,"city":96,"state":81,"zip":97,"country":83,"geoPoint":98},"Yale Interventional Spine and Musculoskeletal Medicine - Old Saybrook","Old Saybrook","06475",{"lat":99,"lon":100},41.29177,-72.3762,[102,107],{"name":103,"role":104,"phone":105,"email":106},"Charles A Odonkor, MD","CONTACT","203-767-1555","kcodonkor@aya.yale.edu",{"name":108,"role":104,"phone":109,"email":110},"Muhammad U Siddique, MD","203-668-2772","muhammad.siddique@yale.edu",[112],{"name":103,"affiliation":13,"role":113},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":117,"biomarkers":120},[118,119],"Lower Back Pain","Vertebrogenic pain syndrome",[],{"nct_id":4,"found":122,"summary":123,"prompt_version":133},true,{"design":124,"status":125,"heading":126,"summary":127,"follow_up":128,"word_count":129,"commitments":130,"compensation":131,"drugs_mentioned":132},"This is an observational study involving 200 participants. It is not a randomized trial, meaning participants are not assigned to different treatment groups.","completed","Observational Study of Basivertebral Nerve Ablation for Low Back Pain","This study is looking at how well a procedure called basivertebral nerve ablation (BVNA) using the Intracept® System helps people with chronic low back pain caused by changes in their spine (vertebrogenic pain). Doctors want to understand how pain relief and daily function improve over time after this procedure. They also want to find out what factors might predict who will respond best to the treatment. You might be able to join if you are an adult with chronic low back pain, are scheduled for BVNA, and can participate in regular follow-up appointments for up to two years. The main goal is to see what percentage of participants achieve a significant reduction in their pain or improvement in their daily activities after two years.","Participants will be followed for two years after the procedure to assess their clinical response.",124,"You would have a baseline visit, followed by 8 weekly virtual\u002Fphone visits, and then virtual or in-person visits at 3, 6, 12, and 24 months.","Not stated in the trial record.",[24],"v2"]