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

RecruitingEARLY Phase 1Ages 18 Years - 65 YearsAllNational Institute of Geriatrics, Rheumatology an…
NCT07675304 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: Age 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 Exclusion Criteria: Known allergy to collagen or lignocaine Active malignancy Autoimmune diseases Skin lesions in the lumbosacral region Active infection Lack of informed consent
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What it tests

  • Tropocollagen type I
  • Lignocaine 1% concentration solution
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Where

1 site
National Institute of Geriatrics, Rheumatology and Rehabilitation
Warsaw, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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