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

NCT06807177 | Enrolling By Invitation

• 1 other identifier: KBT-517/2022
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

mesotherapy; tnf alpha; interleukin 6; collagen type I; lignocaine; interleukin 1-beta

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Injection type I collagen

Injection 1% lignocaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

National Institute of Geriatric, Rheumatology and Rehabilitation

Warsaw, 02-637, Poland

Location

Related Publications (1)

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples will be collected as serum.

MeSH Terms

Conditions

Spondylarthritis; Neck Pain; Osteogenesis Imperfecta, Type IV

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: January 8, 2025
• Primary Completion: September 15, 2025
• Study Completion: January 12, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)