Cervical Pain, Myofascial Pain Syndrome - Neck, Neck Pain, Spondyloarthrosis
Conditions
Keywords
mesotherapy, tnf alpha, interleukin 6, collagen type I, lignocaine, interleukin 1-beta
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.
Interventions
None listed
Sponsors
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of anti-inflammatory markers | 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 | Blood collection before starting the mesotherapy treatment (on the same day), one week after its completion, and after 6 weeks follow-up |
Countries
Poland
Outcome results
None listed