Clinical trial NCT06807177: Assessment of Anti-inflammatory Markers Concentration, Effectiveness and Safety After Spinal Mesotherapy in Chronic Cervical Pain Syndrome
Official title: Assessment of Anti-inflammatory Markers Concentration, Effectiveness and Safety After Spinal Mesotherapy (LIT) in Chronic Cervical Pain Syndrome
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Myofascial Pain Syndrome - Neck
Spondyloarthrosis
Neck Pain
Cervical Pain
Keywords: mesotherapy
tnf alpha
interleukin 6
interleukin 12
collagen type I
lignocaine
Lead sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Sponsor class: NETWORK
First posted: 2025-02-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 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.

Material and methods:

The study was conducted on patients aged 18 to 65 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-6, interleukin-12). Again, a week after the end of mesotherapy (five treatments) and after 3 months 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 Visual Analogue Scale (VAS) and the Laitinen scale will be used.

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

Primary outcomes:
measure: Concentration of anti-inflammatory markers
timeFrame: Blood collection before starting the mesotherapy treatment (on the same day), one week after its completion (after 5 weeks from start), and after 12 weeks from end
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: National Institute of Geriatric, Rheumatology and Rehabilitation
Study officials:
References: