RecruitingEarly Phase 1NCT07675304

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


Sponsor

National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

Enrollment

90 participants

Start Date

May 6, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Lignocaine 1% concentration solution and Tropocollagen type I for people with chronic low back pain (non-specific, uncomplicated). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTropocollagen 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

DRUGLignocaine 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.


Locations(1)

National Institute of Geriatrics, Rheumatology and Rehabilitation

Warsaw, Poland

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NCT07675304


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