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

NCT07675304 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-06-30

No results posted yet for this study

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.

Conditions

  • Chronic Low Back Pain (Non-specific, Uncomplicated)

Interventions

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

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.

Sponsors & Collaborators

  • National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-06
Primary Completion
2026-12-31
Completion
2027-03-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07675304 on ClinicalTrials.gov