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RECRUITING
NCT07675304
EARLY_PHASE1

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

Sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

View on ClinicalTrials.gov

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.

Official title: Evaluation of the Effectiveness and Safety of Mesotherapy in the Treatment of Chronic Low Back Pain Syndrome: a Randomized Study

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-05-06

Completion Date

2027-03

Last Updated

2026-06-30

Healthy Volunteers

No

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.

Locations (1)

National Institute of Geriatrics, Rheumatology and Rehabilitation

Warsaw, Poland