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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Neck Pain; Cervical Pain; Spondyloarthrosis; Myofascial Pain Syndrome - Neck

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 02-637
    • National Institute of Geriatric, Rheumatology and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with chronic cervical spine pain, of a muscular, myofascial and overload nature, will be qualified for the study and undergo spinal mesotherapy.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Injection type I collagen
Injection 1% lignocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of anti-inflammatory markers	Blood collection before starting the mesotherapy treatment (on the same day), one week after its completion, and after 6 weeks follow-up	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2025
• Primary Completion (Actual): September 15, 2025
• Study Completion (Estimated): January 12, 2026

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): February 4, 2025

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: mesotherapy; lignocaine; interleukin 6; tnf alpha; collagen type I; interleukin 1-beta
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylitis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Spondylarthritis; Neck Pain; Osteogenesis Imperfecta, Type IV
• Other Study ID Numbers: KBT-517/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No