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

June 29, 2026 updated by: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

CLBP is a prevalent musculoskeletal condition associated with functional impairment and reduced quality of life. Conservative management includes pharmacotherapy, physiotherapy, and minimally invasive interventions.

Mesotherapy is a technique involving multiple intradermal microinjections of active substances into the affected area. Collagen-based preparations, such as type I tropocollagen, are hypothesized to support tissue regeneration and reduce pain through structural and biochemical mechanisms. Lignocaine is a local anesthetic widely used for pain control.

The objective of this study is to compare the effectiveness of collagen mesotherapy with lignocaine and combination therapy in patients with chronic low back pain localized to the lumbosacral region.

Participants will be randomly assigned to one of three parallel groups: type I tropocollagen, 1% lignocaine, or a combination of both. Each participant will undergo five treatment sessions performed once weekly and will remain in the assigned group throughout the study period.

During each session, approximately 20 intradermal microinjections will be injected into the paraspinal soft tissues of the lumbosacral region. Each injection will contain 0.1 mL of the assigned intervention: type I tropocollagen, 1% lignocaine, or their combination.

The effects of the interventions on pain intensity, functional status, and mobility of the lumbosacral spine will be evaluated using validated outcome measures.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland
        • Recruiting
        • National Institute of Geriatrics, Rheumatology and Rehabilitation
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tropocollagen Group
Participants receive type I tropocollagen administered using mesotherapy. Treatment consists of approximately 20 intradermal microinjections of 0.1 mL each injected into the paraspinal soft tissues of the lumbosacral region. The procedure is performed once weekly for five consecutive weeks.
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
Active Comparator: Lignocaine Group
Participants receive 1% lignocaine administered using mesotherapy. Treatment consists of approximately 20 intradermal microinjections of 0.1 mL each injected into the paraspinal soft tissues of the lumbosacral region. The procedure 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.
Active Comparator: Tropocollagen + Lignocaine Group
Participants receive a combination of type I tropocollagen and 1% lignocaine administered using mesotherapy. Treatment consists of approximately 20 intradermal microinjections of 0.1 mL each injected into the paraspinal soft tissues of the lumbosacral region. The procedure is performed once weekly for five consecutive weeks
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain intensity assessed using the Numeric Rating Scale (NRS)
Time Frame: From baseline to 3 months after treatment completion, including weekly assessments during the 5-week treatment period and assessment 1 week after treatment completion.
Pain intensity will be assessed using the Numeric Rating Scale (NRS), an 11-point patient-reported scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain. Assessments will be performed at baseline, during each weekly treatment session, one week after completion of treatment, and three months after completion of treatment. Changes in NRS scores from baseline to each follow-up time point will be evaluated.
From baseline to 3 months after treatment completion, including weekly assessments during the 5-week treatment period and assessment 1 week after treatment completion.
Change in pain severity assessed using the Laitinen Pain Scale
Time Frame: From baseline to 3 months after treatment completion, including weekly assessments during the 5-week treatment period and assessment 1 week after treatment completion.
Pain severity will be assessed using the Laitinen Pain Scale, a multidimensional scale evaluating pain intensity, pain frequency, analgesic use, and physical activity. The total score ranges from 0 to 16. Higher scores indicate worse pain severity and functional impairment. Assessments will be performed at baseline, during each weekly treatment session, one week after completion of treatment, and three months after completion of treatment. Changes in Laitinen Pain Scale scores from baseline to each follow-up time point will be evaluated.
From baseline to 3 months after treatment completion, including weekly assessments during the 5-week treatment period and assessment 1 week after treatment completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

April 23, 2026

First Submitted That Met QC Criteria

June 29, 2026

First Posted (Actual)

June 30, 2026

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S/34/2026/ZSchNR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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