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Enrolling by invitation NCT06807177

Can Blood Biomarkers of Inflammation and BDNF be Used to Assess the Effectiveness of Collagen Mesotherapy in Chronic CMPS?

— Observational Myofascial Pain Syndrome - Neck Spondyloarthrosis Neck Pain Cervical Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Myofascial Pain Syndrome - Neck, Spondyloarthrosis, Neck Pain, Cervical Pain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Can Blood Biomarkers of Inflammation and BDNF be Used to Assess the Effectiveness of Collagen Mesotherapy in Chronic Cervical Myofascial Pain Syndrome?

Overview

The aim of the study is to assess the concentration of anti-inflammatory markers after the use of cervical spine mesotherapy in the course of pain syndrome. The study is randomized. Patients will be divided into two groups: A - mesotherapy using injectable type I collagen, B - mesotherapy using 1% lignocaine. The mesotherapy procedure will be performed five times, at weekly intervals. Blood will be collected before the start of mesotherapy, a week after its completion and after 3 months of follow-up. In addition, the effectiveness and safety of mesotherapy of the cervical spine will be assessed.

Detailed description

Study aim:

The main objective of this article was to answer the question: Can biomarkers of inflammatory processes in the blood and BDNF be used to evaluate the effectiveness of collagen mesotherapy in chronic CMPS? The second objective of this article is to evaluate the safety of collagen mesotherapy in chronic CMPS.

Material and methods:

The study was conducted on patients aged 18 to 80 years, of both sexes, with local, chronic cervical spine pain syndrome, without radiation of symptoms to the upper limb. The study subjects were recruited at the National Institute of Geriatric, Rheumatology and Rehabilitation in Warsaw. Patients will be recruited according to the inclusion and exclusion criteria. The study is randomized. Patients will be divided into two groups: A - mesotherapy using injectable type I collagen, B - mesotherapy using 1% lignocaine.

Each patient will have blood collected before starting mesotherapy (on the same day) to determine anti-inflammatory markers (TNF-alpha, interleukin-1-beta, interleukin-6) and BDNF. Again, a week after the end of mesotherapy (five treatments) and after 6-week of follow-up, blood will be collected to determine the same markers.

In addition, the effectiveness and safety of mesotherapy of the cervical spine will be assessed. A Numeric Rating Scale (VAS) and the Neck Disability Index (NDI) scale will be used.

Primary outcome measures

  • Concentration of anti-inflammatory markers [Time frame: Blood collection before starting the mesotherapy treatment (on the same day), one week after its completion (after 5 weeks from start), and after 6 weeks from end]

Eligibility criteria

Inclusion criteria

  • patients with chronic (>12 weeks) cervical spine pain syndrome of muscular, myofascial nature without radiation to the upper limb
  • recent MRI or CT scan of the cervical spine (up to 6 months)
  • no serious diseases: cancer, rheumatology, metabolic
  • no allergy to lignocaine 1% or injectable type I collagen

Exclusion criteria

  • another cause of cervical spine pain
  • lack of patient consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Poland · 1 center
  • National Institute of Geriatric, Rheumatology and Rehabilitation — Warsaw

Publications

  • Koszela K, Paradowska-Gorycka A, Kwiatkowska B, Woldanska-Okonska M, Stypinska B, Ejma-Multanski A, Gasik R. Blood biomarkers of inflammation and brain-derived neurotrophic factor can not be used to assess the effectiveness of collagen mesotherapy in chronic cervical myofascial pain syndrome. A pilot single-blind randomized study. Rheumatol Int. 2026 Mar 2;46(3):56. doi: 10.1007/s00296-026-06094-4 PMID 41770355

Identifiers

NCT: NCT06807177 · KBT-517/2022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗