[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602702":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":54,"collaborators":25,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":25,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":78,"whyStopped":25,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Jaseng Medical Foundation","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ultrasound-guided Deep Pharmacopuncture Treatment","EXPERIMENTAL","Participants in this arm will receive integrative Korean medicine treatment combined with ultrasound-guided deep pharmacopuncture. The integrative treatment includes acupuncture, Chuna manual therapy (focused on cervical and lumbar regions), and oral herbal medicine administered during hospitalization.\n\nIn addition to these treatments, patients in this group will receive ultrasound-guided pharmacopuncture therapy once daily from Day 2 to Day 4 of hospitalization, for a maximum of three sessions. The pharmacopuncture procedure involves injecting 4 cc of herbal extract into deep lumbar tissue using a 26G sterile needle under real-time ultrasound guidance. The target site is selected based on lumbar spine X-ray findings (disc narrowing) and patient-reported radiating pain. The needle is inserted using an in-plane approach to visualize the needle tip reaching the posterior facet joint of the most symptomatic lumbar segment.",[13],"Procedure: Korean medical treatment",{"label":15,"type":16,"description":17,"interventionNames":18},"Korean medical treatment","ACTIVE_COMPARATOR","The control group were received Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.",[19,13],"Procedure: Ultrasound-guided Deep Pharmacopuncture Treatment",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Participants in this group will receive ultrasound-guided deep pharmacopuncture in addition to integrative Korean medicine treatment (acupuncture, herbal medicine, and Chuna therapy). The pharmacopuncture involves injecting 4 cc of herbal extract into deep lumbar tissues, targeting the posterior facet joint of the most symptomatic segment.\n\nUsing a real-time ultrasound-guided in-plane technique, the needle path and tip are visualized to ensure accurate and safe delivery. Treatment is administered once daily for up to 3 days (hospital Days 2-4).\n\nThis intervention differs from conventional methods by using ultrasound to guide precise, deep-tissue injection, enhancing both safety and treatment accuracy.",[15],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine",[15,9],[30],{"name":31,"affiliation":5,"role":32},"In-Hyuk Ha, phD","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","02-2222-2740","hanitata@jaseng.co.kr",[39],{"facility":40,"status":25,"city":41,"state":40,"zip":42,"country":43,"countryCode":25,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Jaseng Hospital of Korean Medicine","Haeundae","135-896","South Korea",{"type":45,"coordinates":46},"Point",[47,48],129.15472,35.16,{"lat":48,"lon":47},[51],{"name":31,"role":35,"phone":52,"phoneExt":25,"email":53},"3218-2249 Ext. 82","hanihata@jaseng.co.kr",{"type":55,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100602702","pilot-study-clinical-trial-of-ultrasound-guiding-pharmacopuncture-therapy-for-acute-low-back-pain-100602702",false,"NCT07126951","Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain","A Pragmatic Randomized Controlled Pilot Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain Following Traffic Accidents","Inclusion Criteria:\n\nParticipants must meet all of the following:\n\nAdults aged 19 to 70 years.\n\nPatients who developed acute low back pain within 7 days after a traffic accident.\n\nNumeric Rating Scale (NRS) score of 5 or higher for low back pain.\n\nRadiological evidence of disc narrowing on lumbar spine X-ray.\n\nComplaints of radiating leg pain.\n\nHospitalized for treatment related to the traffic accident.\n\nAble and willing to provide written informed consent voluntarily.\n\nExclusion Criteria:\n\nParticipants will be excluded if they meet any of the following:\n\nDiagnosed with serious underlying conditions causing back pain (e.g., malignancy, spinal infection, inflammatory spondylitis).\n\nPresence of progressive or severe neurological deficits.\n\nUnderwent lumbar surgery or procedures within the past 3 weeks.\n\nBack pain caused by non-spinal soft tissue disorders (e.g., fibromyalgia, rheumatoid arthritis, gout).\n\nPresence of chronic conditions that could interfere with study results (e.g., cardiovascular disease, renal disease, diabetic neuropathy, dementia, epilepsy).\n\nTaking medications that could affect study outcomes (e.g., steroids, immunosuppressants, psychiatric drugs).\n\nContraindicated or unsafe for acupuncture (e.g., bleeding disorders, anticoagulant therapy, severe diabetes with infection risk, severe cardiovascular conditions).\n\nCurrently pregnant or planning pregnancy.\n\nDiagnosed with severe mental illness.\n\nParticipation in other clinical trials (excluding observational studies).\n\nUnable to properly complete the informed consent form.\n\nDeemed inappropriate for participation by the investigator for any other reason.","ALL","19 Years","70 Years",{"count":67,"type":68},40,"ESTIMATED","INTERVENTIONAL",[71],"NA","This pilot randomized controlled clinical trial aims to evaluate the effectiveness and safety of ultrasound-guided deep pharmacopuncture therapy for acute low back pain (LBP) that occurs within seven days following a traffic accident. While traditional Korean medicine-including acupuncture, herbal medicine, pharmacopuncture, and Chuna manual therapy-is commonly used for post-accident injuries, few studies have focused on deep pharmacopuncture administered under ultrasound guidance. This study will provide preliminary evidence to assess whether ultrasound-guided techniques offer added clinical benefits.\n\nA total of 40 patients hospitalized at Jaseng Hospital of Korean Medicine in Haeundae, Korea, will be recruited and randomly assigned into two groups: the intervention group will receive integrative Korean medicine therapy plus ultrasound-guided pharmacopuncture, while the control group will receive integrative Korean medicine therapy alone. Both groups will undergo treatment during hospitalization, with the pharmacopuncture administered up to three times between hospital day 2 and day 4 in the intervention group. Baseline assessment will be done on day 2 before treatment, and the primary outcome will be measured on day 5. Follow-up assessments will be conducted at 2 and 4 weeks via telephone.\n\nThe primary outcome is the change in low back pain intensity as measured by the Numeric Rating Scale (NRS). Secondary outcomes include radiating pain, lumbar range of motion, Oswestry Disability Index (ODI), EQ-5D for quality of life, and the Patient Global Impression of Change (PGIC). Adverse events will also be monitored and classified according to established safety criteria.\n\nThis study will utilize both intention-to-treat (ITT) and per-protocol (PP) analyses, with linear mixed models and multiple imputation used to address missing data. Given the limited existing evidence on ultrasound-guided deep pharmacopuncture, this trial is designed to explore its feasibility and provide the groundwork for future large-scale trials.\n\nParticipants will be selected based on strict inclusion and exclusion criteria to ensure safety and consistency. Ethical standards including informed consent, data privacy, and ongoing safety monitoring will be rigorously upheld throughout the study.",[74],"Low Back Pain (LBP)",[76,77],"pharmacopuncture","Ultrasound Guiding","NOT_YET_RECRUITING","2026-06-22",{"date":81,"type":82},"2026-06-24","ACTUAL",{"date":84,"type":68},"2026-09-01",{"date":86,"type":68},"2027-12-31",{"name":5,"class":6},1]