[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623320":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":57,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":26,"eligibilityCriteria":65,"healthyVolunteers":62,"sex":66,"minAge":67,"maxAge":26,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":26,"overallStatus":77,"whyStopped":26,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Indonesia University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group - Thread Embedding Acupuncture (TEA)","EXPERIMENTAL","Participants in this group will receive thread embedding acupuncture using absorbable polydioxanone (PDO) threads implanted bilaterally at EX-B2 acupuncture points corresponding to the lumbar vertebral segments. The procedure will be performed only once weekly at week 0. This intervention is intended to provide continuous stimulation of acupuncture points to reduce disability and improve lumbar flexibility in patients with chronic low back pain.",[13],"Device: Thread Embedding Acupuncture",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group - Sham Thread Embedding Acupuncture","SHAM_COMPARATOR","Participants in the control group will receive a sham thread embedding acupuncture procedure that mimics the intervention in terms of patient positioning, skin preparation, and needle insertion technique, but without implantation of polydioxanone (PDO) threads. No absorbable thread will be left in the tissue. The procedure will be performed only once weekly at week 0. This group serves as a placebo control to evaluate the specific effects of thread embedding acupuncture beyond nonspecific procedural effects.",[19],"Device: Sham Thread Embedding Acupuncture",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Thread Embedding Acupuncture","Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The assigned procedures will be administered once, and outcomes will be evaluated over an 8-week follow-up period.",[9],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"Sham Thread Embedding Acupuncture",[15],[31],{"name":32,"affiliation":33,"role":34},"KEPK FKUI-RSCM","Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital (HREC FMUI-CMH) (Komite Etik Penelitian Kesehatan Fakultas Kedokteran Universitas Indonesia - RSUP Nasional Dr. Cipto Mangunkusumo)","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Desi Recsanti, MD","CONTACT","081321474775","desi.recsanti@office.ui.ac.id",[42],{"facility":43,"status":26,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Universitas Indonesia","Jakarta Pusat","DKI Jakarta","10430","Indonesia","ID",{"type":50,"coordinates":51},"Point",[52,53],106.8223,-6.1818,{"lat":53,"lon":52},[56],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"type":34,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Desi Recsanti","Principal Investigator, Faculty of Medicine, Universitas Indonesia","100623320","effectiveness-of-thread-embedding-acupuncture-at-ex-b2-on-the-oswestry-disability-index-and-finger-to-floor-distance-in-chronic-low-back-pain-100623320",false,"NCT07395102","Effectiveness of Thread-Embedding Acupuncture at EX-B2 on the Oswestry Disability Index and Finger-to-Floor Distance in Chronic Low Back Pain","Inclusion Criteria:\n\n* Male or female participants aged ≥ 18 years\n* Participants experiencing low back pain for at least 3 months (\\>12 weeks)\n* Highest low back pain intensity within the past 2 weeks with a score of ≥ 3 on a 0-10 Numeric Pain Rating Scale (NPRS)\n* Receiving pharmacological therapy with a stable analgesic regimen for at least 2 weeks prior to enrollment\n* Presence of physical functional disability as indicated by an Oswestry Disability Index (ODI) score \\> 20%\n* Willing and able to participate in the study until completion and to provide written informed consent\n\nExclusion Criteria:\n\n* History of hypersensitivity reactions to acupuncture or thread embedding acupuncture, or known allergy to stainless steel or polydioxanone (PDO) threads\n* History of keloid formation\n* Presence of scars (cicatrices) or skin disorders at the thread embedding acupuncture insertion sites in the lower back area\n* Specific spinal pathology including fracture, tumor, infection, or severe lumbar spinal stenosis requiring surgical intervention\n* Structural spinal abnormalities (scoliosis or kyphosis) detected on physical examination\n* History of spinal surgery or indication for spinal surgery due to severe neurological deficits\n* Presence of cardiac disease, hematological disorders, or uncontrolled diabetes mellitus\n* Regular use of systemic steroids, nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, anticoagulants, or topical analgesic medications\n* Receipt of other treatments for low back pain, including dry needling, neuromuscular taping, spinal injections, or acupuncture within the past 2 weeks, or thread embedding acupuncture within the past 6 months\n* Severe cognitive impairment, severe psychiatric or psychological disorders, or history of alcohol or substance abuse\n* Pregnant or breastfeeding women, or women planning pregnancy within the next 6 months\n* Body mass index (BMI) \\\u003C 18 kg\u002Fm²","ALL","18 Years",{"count":69,"type":70},32,"ESTIMATED","INTERVENTIONAL",[73],"NA","Chronic low back pain (CLBP) is a leading cause of disability worldwide and significantly impairs functional capacity and quality of life. Non-pharmacological therapies are recommended as first-line management, and acupuncture has demonstrated potential benefits in reducing pain and disability. Thread embedding acupuncture (TEA) is a modified acupuncture technique that provides prolonged stimulation through the implantation of absorbable polydioxanone (PDO) threads at acupuncture points.\n\nThis randomized controlled trial aims to evaluate the effectiveness of TEA at the EX-B2 points compared with sham TEA in improving disability and lumbar flexibility in patients with chronic non-specific low back pain. Disability will be assessed using the Oswestry Disability Index (ODI), and lumbar flexibility will be measured using the Finger-to-Floor Distance (FFD) test over an 8-week follow-up period.",[76],"Chronic Low-back Pain","NOT_YET_RECRUITING","2026-02-03",{"date":80,"type":81},"2026-02-09","ACTUAL",{"date":83,"type":70},"2026-02",{"date":85,"type":70},"2026-05",{"name":5,"class":6},1]