drugset / Trial / NCT07675304

Evaluation of the Effectiveness and Safety of Mesotherapy in the Treatment of Chronic Low Back Pain Syndrome

NCT07675304

RandomizedParallel-groupDouble-blindTreatment

Summary

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. Mesotherapy 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. A total of five treatment sessions will be performed at weekly intervals. During 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.

Timeline

Start
2026-05-06
Primary completion
2026-12
Completion
2027-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lidocaine Other / unclassified 0.1 ml Other
Subject Tropocollagen type I Unknown 0.1 ml Other

Indications

No indication recorded.