Myofascial Pain Syndrome - NeckNCT06807177
Can Blood Biomarkers of Inflammation and BDNF be Used to Assess the Effectiveness of Collagen Mesotherapy in Chronic CMPS?
An observational study of Myofascial Pain Syndrome - Neck and Spondyloarthrosis, run by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myofascial Pain Syndrome - Neck, Spondyloarthrosis, Neck Pain
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 8 Jan 2025to 12 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- another cause of cervical spine pain
- lack of patient consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
National Institute of Geriatric, Rheumatology and Rehabilitation
Warsaw, 02-637
About this study
Official title: 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.
Read the 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.
- Keywords
- mesotherapy, tnf alpha, interleukin 6, collagen type I, lignocaine, interleukin 1-beta
- Medical subject headings
- Spondylarthritis, Neck Pain, Osteogenesis Imperfecta, Type IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Injection type I collagen | Not described | |
| Injection 1% lignocaine | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start8 Jan 2025
- Primary completion15 Sep 2025
- Study completion12 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain Syndrome - NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807177
- Sponsor's protocol ID
- KBT-517/2022
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41770355
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Blood Biomarkers of Inflammation and BDNF be Used to Assess the Effectiveness of Collagen Mesotherapy in Chronic Cervical Myofascial Pain Syndrome?
- ClinicalTrials.gov ID
- NCT06807177
- Acronym / sponsor ID
- KBT-517/2022
- Keywords
- mesotherapy, tnf alpha, interleukin 6, collagen type I, lignocaine, interleukin 1-beta
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Institute of Geriatrics, Rheumatology and Rehabilitation, PolandResearch network
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 12 Jan 2026 (estimated)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injection type I collagen | – | – |
| Injection 1% lignocaine | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- another cause of cervical spine pain
- lack of patient consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concentration of anti-inflammatory markers
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Derived from this study: PubMed 41770355Koszela 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myofascial Pain Syndrome - Neck and Spondyloarthrosis, run by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of anti-inflammatory markers (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06807177, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.