[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644826":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":29,"locations":35,"responsibleParty":58,"collaborators":29,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":29,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":29,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":29,"overallStatus":38,"whyStopped":29,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland","NETWORK",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Tropocollagen Group","ACTIVE_COMPARATOR","Participants receive type I tropocollagen administered using mesotherapy. Treatment consists of approximately 20 intradermal microinjections of 0.1 mL each injected into the paraspinal soft tissues of the lumbosacral region. The procedure is performed once weekly for five consecutive weeks.",[13],"Other: Tropocollagen type I",{"label":15,"type":10,"description":16,"interventionNames":17},"Lignocaine Group","Participants receive 1% lignocaine administered using mesotherapy. Treatment consists of approximately 20 intradermal microinjections of 0.1 mL each injected into the paraspinal soft tissues of the lumbosacral region. The procedure is performed once weekly for five consecutive weeks.",[18],"Drug: Lignocaine 1% concentration solution",{"label":20,"type":10,"description":21,"interventionNames":22},"Tropocollagen + Lignocaine Group","Participants receive a combination of type I tropocollagen and 1% lignocaine administered using mesotherapy. Treatment consists of approximately 20 intradermal microinjections of 0.1 mL each injected into the paraspinal soft tissues of the lumbosacral region. The procedure is performed once weekly for five consecutive weeks",[13,18],[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"OTHER","Tropocollagen type I","Type I tropocollagen is administered using mesotherapy as approximately 20 microinjections of 0.1 mL each into the paraspinal soft tissues of the lumbosacral region. The treatment is performed once weekly for five consecutive weeks",[20,9],null,{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":29},"DRUG","Lignocaine 1% concentration solution","Lignocaine 1% is administered using mesotherapy as approximately 20 microinjections of 0.1 mL each into the paraspinal soft tissues of the lumbosacral region. The treatment is performed once weekly for five consecutive weeks.",[15,20],[36],{"facility":37,"status":38,"city":39,"state":29,"zip":29,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"National Institute of Geriatrics, Rheumatology and Rehabilitation","RECRUITING","Warsaw","Poland","PL",{"type":43,"coordinates":44},"Point",[45,46],21.01178,52.22977,{"lat":46,"lon":45},[49,54],{"name":50,"role":51,"phone":52,"phoneExt":29,"email":53},"Kamil Koszela, PhD","CONTACT","+48 601441115","kamil.aikido@interia.pl",{"name":55,"role":51,"phone":56,"phoneExt":29,"email":57},"Agnieszka Guz, MD","+48 604638529","agnieszkaa.guz@gmail.com",{"type":59,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100644826","early-phase-1-evaluation-of-the-effectiveness-and-safety-of-mesotherapy-in-the-treatment-of-chronic-low-back-pain-syndrome-100644826",false,"NCT07675304","Evaluation of the Effectiveness and Safety of Mesotherapy in the Treatment of Chronic Low Back Pain Syndrome","Evaluation of the Effectiveness and Safety of Mesotherapy in the Treatment of Chronic Low Back Pain Syndrome: a Randomized Study","Inclusion Criteria:\n\nAge between 18 and 65 years Chronic localized pain in the lumbosacral spine without radicular symptoms or radiation to the lower limbs Recent spinal imaging (X-ray, computed tomography (CT), or magnetic resonance imaging (MRI)) performed within the last 6 months confirming the diagnosis\n\nExclusion Criteria:\n\nKnown allergy to collagen or lignocaine Active malignancy Autoimmune diseases Skin lesions in the lumbosacral region Active infection Lack of informed consent","ALL","18 Years","65 Years",{"count":71,"type":72},90,"ESTIMATED","INTERVENTIONAL",[75],"EARLY_PHASE1","The aim of this study is to evaluate the effectiveness of collagen mesotherapy in the treatment of chronic low back pain (CLBP) in the lumbosacral spine.\n\nMesotherapy is expected to reduce pain in the lumbosacral region, decrease soft tissue tension (including muscles, fascia, and ligaments), improve spinal mobility, and support subsequent physiotherapy.\n\nA total of five treatment sessions will be performed at weekly intervals.\n\nDuring each session, approximately 20 intradermal microinjections will be administered into the paraspinal soft tissues of the lumbosacral region. Participants will receive injections of either type I tropocollagen, 1% lignocaine (lidocaine), or a combination of both, with a volume of 0.1 mL per injection.",[78],"Chronic Low Back Pain (Non-specific, Uncomplicated)","2026-06-29",{"date":81,"type":82},"2026-06-30","ACTUAL",{"date":84,"type":82},"2026-05-06",{"date":86,"type":72},"2027-03",{"name":5,"class":6},1]