[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06745453":3,"trial-entities:NCT06745453":114,"trial-summary:NCT06745453":118},{"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":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":40,"secondary_outcomes":45,"sex":70,"minimum_age":71,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":72,"std_ages":83,"locations":86,"central_contacts":107,"overall_officials":110,"references":112,"see_also_links":113},"NCT06745453","24062802","Erector Spinae Plane Block for Acute Back Pain in the Emergency Department","RECRUITING","2026-12-31","2026-03","2026-03-12","2025-02-03","Rush University Medical Center","OTHER",false,"The goal of this clinical trial is to learn if an erector spinae plane block (ESPB; a type of nerve block) works to reduce pain in adults presenting to the emergency department with low back pain. It will also learn if the ESPB reduces pain, disability, and return to work at 7 days. The main questions it aims to answer are:\n\n1. Does the ESPB reduce short-term pain in participants with low back pain?\n2. Does the ESPB reduce longer-term pain, reduce disability, and improve return to work and activities in participants with low back pain?\n\nResearchers will compare ESPB to a placebo (an injection that does not involve a nerve block) to see if ESPB works to treat low back pain.\n\nParticipants will:\n\nReceive either the ESPB or a placebo injection in the emergency department Report their pain scores for up to 120 minutes Report their pain, disability, and return to work at 7 days",null,[18],"Low Back Pain",[20,21,22,23,24],"erector spinae plane block","emergency department","low back pain","regional anesthesia","nerve block","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},62,"ESTIMATED",[33,37],{"type":34,"name":35,"description":35,"armGroupLabels":36},"PROCEDURE","Erector Spinae Plane Block",[35],{"type":34,"name":38,"description":38,"armGroupLabels":39},"Sham Procedure",[38],[41],{"measure":42,"description":43,"timeFrame":44},"Pain score at 120 minutes post-intervention as assessed using a 10-point numeric rating scale","Zero is equivalent to no pain and 10 indicates worst pain imaginable","Change from baseline to 120 minutes post-intervention",[46,49,52,56,59,63,67],{"measure":47,"description":43,"timeFrame":48},"Pain score at 30 minutes post-intervention as assessed using a 10-point numeric rating scale","Change from baseline to 30 minutes post-intervention",{"measure":50,"description":43,"timeFrame":51},"Pain score at 60 minutes post-intervention as assessed using a 10-point numeric rating scale","Change from baseline to 60 minutes post-intervention",{"measure":53,"description":54,"timeFrame":55},"Degree of disability assessed via the Roland-Morris disability questionnaire at 7 days","Participants will be scored using the validated Roland-Morris disability questionnaire.","Assessed as the change in Roland-Morris disability questionnaire scores between baseline and 7 day follow up",{"measure":57,"description":43,"timeFrame":58},"Pain score at 7 days post-intervention as assessed using a 10-point numeric rating scale","Pain score assessed at 7 days post-intervention",{"measure":60,"description":61,"timeFrame":62},"Opioid medications taken in the 7 days following the intervention","Calculated in morphine milligram equivalents","Measured at 7 days post-intervention",{"measure":64,"description":65,"timeFrame":66},"Follow up visits related to low back pain in the 7 days following the intervention","Based upon patient self-report","Assessed at 7 days",{"measure":68,"description":69,"timeFrame":66},"Return to work and activities assessed via the Work Productivity and Activity Impairment Questionnaire: General Health version 2.0","Assessed using the validated Work Productivity and Activity Impairment Questionnaire: General Health version 2.0 questionnaire","ALL","18 Years",{"inclusion":73,"exclusion":75,"raw_text":82},[74],"Adults (age ≥18 years) presenting to the emergency department with isolated low back pain present less than 6 total weeks.",[76,77,78,79,80,81],"Do not speak English or Spanish as a primary language","Are incarcerated","Have a known pregnancy","Are allergic to amide-type local anesthetics","Are unable to tolerate positioning for the procedure","Have a critical illness precluding the ability to perform the procedure.","Inclusion Criteria:\n\n* Adults (age ≥18 years) presenting to the emergency department with isolated low back pain present less than 6 total weeks.\n\nExclusion Criteria:\n\n* Do not speak English or Spanish as a primary language\n* Are incarcerated\n* Have a known pregnancy\n* Are allergic to amide-type local anesthetics\n* Are unable to tolerate positioning for the procedure\n* Have a critical illness precluding the ability to perform the procedure.",[84,85],"ADULT","OLDER_ADULT",[87],{"facility":12,"status":7,"city":88,"state":89,"zip":90,"country":91,"contacts":92,"geoPoint":104},"Chicago","Illinois","60612","United States",[93,98,101],{"name":94,"role":95,"phone":96,"email":97},"Aylin Ornelas Loredo, MMS","CONTACT","312-563-0645","aylin_a_ornelasloredo@rush.edu",{"name":99,"role":95,"phone":96,"email":100},"Michelle Santangelo, MS","michelle_santangelo@rush.edu",{"name":102,"role":103},"Michael Gottlieb, MD","PRINCIPAL_INVESTIGATOR",{"lat":105,"lon":106},41.85003,-87.65005,[108,109],{"name":94,"role":95,"phone":96,"email":97},{"name":99,"role":95,"phone":96,"email":100},[111],{"name":102,"affiliation":12,"role":103},[],[],{"nct_id":4,"conditions":115,"biomarkers":117},[116],"Lower Back Pain",[],{"nct_id":4,"found":119,"summary":120,"prompt_version":130},true,{"design":121,"status":122,"heading":123,"summary":124,"follow_up":125,"word_count":126,"commitments":127,"compensation":128,"drugs_mentioned":129},"This is an interventional study comparing an Erector Spinae Plane Block to a sham procedure. It plans to enroll 62 participants.","completed","Erector Spinae Plane Block for Acute Back Pain","This study is looking at whether an Erector Spinae Plane Block (ESPB), a type of nerve block, can help reduce acute low back pain in adults who come to the emergency department. Researchers want to see if ESPB lessens pain quickly and also helps with pain, disability, and returning to work after 7 days. You might be able to join if you are an adult (18 or older) with low back pain for less than six weeks. The study will compare ESPB to a sham procedure (a pretend injection that doesn't involve a nerve block) to see if ESPB is effective. The main goal is to measure your pain score 120 minutes after the procedure.","The study will assess pain, disability, and return to work at 7 days after the intervention.",115,"Not specified in the trial record.","Not stated in the trial record.",[35,38],"v2"]