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NCT07675304
Evaluation of the Effectiveness and Safety of Mesotherapy in the Treatment of Chronic Low Back Pain Syndrome
Conditions: Chronic Low Back Pain (Non-specific, Uncomplicated)
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 90
Sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Location: National Institute of Geriatrics, Rheumatology and Rehabilitation Warsaw
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 Criteria
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
Source: ClinicalTrials.gov (NCT07675304). StuddyBuddy aggregates publicly available trial information.