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

NCT ID: NCT06807177

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-08
• Study Completion Date: 2026-01-12

Brief Summary

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.

Conditions

Myofascial Pain Syndrome - Neck; Spondyloarthrosis; Neck Pain; Cervical Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Injection type I collagen

No interventions assigned to this group

Injection 1% lignocaine

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Institute of Geriatric, Rheumatology and Rehabilitation

Warsaw, , Poland

Countries

Poland

Other Identifiers

KBT-517/2022

Identifier Type: -

Identifier Source: org_study_id