Chronic Low Back Pain (Non-specific, Uncomplicated)Early Phase 1NCT07675304
Evaluation of the Effectiveness and Safety of Mesotherapy in the Treatment of Chronic Low Back Pain Syndrome
A Early Phase 1 study testing Tropocollagen type I and Lignocaine 1% concentration solution in people with Chronic Low Back Pain (Non-specific, Uncomplicated), run by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland at 1 site in Poland.
Trial summary
The aim of this study is to evaluate the effectiveness of collagen mesotherapy in the treatment of chronic low back pain (CLBP) in the lumbosacral spine. Mesotherapy is expected to reduce pain in the lumbosacral region, decrease soft tissue tension (including muscles, fascia, and ligaments), improve spinal mobility… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain (Non-specific, Uncomplicated)
- What is being tested?
- Tropocollagen type I and Lignocaine 1% concentration solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 6 May 2026to Mar 2027
- Phase
- Early Phase 1
- 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
Who may be able to join
- Age between 18 and 65 years Chronic localized pain in the lumbosacral spine without radicular symptoms or radiation to the lower limbs Recent spinal imaging (X-ray, computed tomography (CT), or magnetic resonance imaging (MRI)) performed within the last 6 months confirming the diagnosis
Who cannot join
- Known allergy to collagen or lignocaine Active malignancy Autoimmune diseases Skin lesions in the lumbosacral region Active infection Lack of informed 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, 1 recruiting
- Recruiting
National Institute of Geriatrics, Rheumatology and Rehabilitation
Warsaw
Kamil Koszela, PhD, +48 601441115, kamil.aikido@interia.pl
Agnieszka Guz, MD, +48 604638529, agnieszkaa.guz@gmail.com
About this study
Official title: Evaluation of the Effectiveness and Safety of Mesotherapy in the Treatment of Chronic Low Back Pain Syndrome: a Randomized Study
The aim of this study is to evaluate the effectiveness of collagen mesotherapy in the treatment of chronic low back pain (CLBP) in the lumbosacral spine.
Mesotherapy is expected to reduce pain in the lumbosacral region, decrease soft tissue tension (including muscles, fascia, and ligaments), improve spinal mobility, and support subsequent physiotherapy.
Read more
A total of five treatment sessions will be performed at weekly intervals.
During each session, approximately 20 intradermal microinjections will be administered into the paraspinal soft tissues of the lumbosacral region. Participants will receive injections of either type I tropocollagen, 1% lignocaine (lidocaine), or a combination of both, with a volume of 0.1 mL per injection.
Read the detailed description
CLBP is a prevalent musculoskeletal condition associated with functional impairment and reduced quality of life. Conservative management includes pharmacotherapy, physiotherapy, and minimally invasive interventions.
Mesotherapy is a technique involving multiple intradermal microinjections of active substances into the affected area. Collagen-based preparations, such as type I tropocollagen, are hypothesized to support tissue regeneration and reduce pain through structural and biochemical mechanisms. Lignocaine is a local anesthetic widely used for pain control.
The objective of this study is to compare the effectiveness of collagen mesotherapy with lignocaine and combination therapy in patients with chronic low back pain localized to the lumbosacral region.
Participants will be randomly assigned to one of three parallel groups: type I tropocollagen, 1% lignocaine, or a combination of both. Each participant will undergo five treatment sessions performed once weekly and will remain in the assigned group throughout the study period.
During each session, approximately 20 intradermal microinjections will be injected into the paraspinal soft tissues of the lumbosacral region. Each injection will contain 0.1 mL of the assigned intervention: type I tropocollagen, 1% lignocaine, or their combination.
The effects of the interventions on pain intensity, functional status, and mobility of the lumbosacral spine will be evaluated using validated outcome measures.
- Being tested
- Tropocollagen type I, Lignocaine 1% concentration solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tropocollagen type IOther
Type I tropocollagen is administered using mesotherapy as approximately 20 microinjections of 0.1 mL each into the paraspinal soft tissues of the lumbosacral region. The treatment is performed once weekly for five consecutive weeks
Lignocaine 1% concentration solutionDrug
Lignocaine 1% is administered using mesotherapy as approximately 20 microinjections of 0.1 mL each into the paraspinal soft tissues of the lumbosacral region. The treatment is performed once weekly for five consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tropocollagen Group | Active comparator | Participants receive type I tropocollagen administered using mesotherapy. Treatment consists of approximately 20 intradermal microinjections of 0.1 mL each injected into the paraspinal soft tissues of the lumbosacral region. The procedure is performed once weekly for five consecutive weeks. Receives: Other: Tropocollagen type I |
| Lignocaine Group | Active comparator | Participants receive 1% lignocaine administered using mesotherapy. Treatment consists of approximately 20 intradermal microinjections of 0.1 mL each injected into the paraspinal soft tissues of the lumbosacral region. The procedure is performed once weekly for five consecutive weeks. Receives: Drug: Lignocaine 1% concentration solution |
| Tropocollagen + Lignocaine Group | Active comparator | Participants receive a combination of type I tropocollagen and 1% lignocaine administered using mesotherapy. Treatment consists of approximately 20 intradermal microinjections of 0.1 mL each injected into the paraspinal soft tissues of the lumbosacral region. The procedure is performed once weekly for five consecutive weeks Receives: Other: Tropocollagen type I; Drug: Lignocaine 1% concentration solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity assessed using the Numeric Rating Scale (NRS)
Pain intensity will be assessed using the Numeric Rating Scale (NRS), an 11-point patient-reported scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain. Assessments will be performed at baseline, during each weekly treatment session, one week after completion of treatment, and three months after completion of treatment. Changes in NRS scores from baseline to each follow-up time point will be evaluated.
Measured: From baseline to 3 months after treatment completion, including weekly assessments during the 5-week treatment period and assessment 1 week after treatment completion.
Change in pain severity assessed using the Laitinen Pain Scale
Pain severity will be assessed using the Laitinen Pain Scale, a multidimensional scale evaluating pain intensity, pain frequency, analgesic use, and physical activity. The total score ranges from 0 to 16. Higher scores indicate worse pain severity and functional impairment. Assessments will be performed at baseline, during each weekly treatment session, one week after completion of treatment, and three months after completion of treatment. Changes in Laitinen Pain Scale scores from baseline to each follow-up time point will be evaluated.
Measured: From baseline to 3 months after treatment completion, including weekly assessments during the 5-week treatment period and assessment 1 week after treatment completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start6 May 2026
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (Non-specific, Uncomplicated)Studies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three parallel groups: type I tropocollagen, 1% lignocaine, or a combination of both. Each participant will receive five treatment sessions performed once weekly and will remain in the assigned group throughout the study period. Masking is ensured by preparation of study substances by an independent physician who is not involved in treatment administration. The prepared substances are provided in identical syringes, and the preparations are visually indistinguishable. Both participants and the treating physician remain masked to group allocation.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 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
- NCT07675304
- Sponsor's protocol ID
- S/34/2026/ZSchNR
- Status last verified
- May 2026
- First submitted
- 23 Apr 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness and Safety of Mesotherapy in the Treatment of Chronic Low Back Pain Syndrome: a Randomized Study
- ClinicalTrials.gov ID
- NCT07675304
- Acronym / sponsor ID
- S/34/2026/ZSchNR
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Institute of Geriatrics, Rheumatology and Rehabilitation, PolandResearch network
- Study start
- 6 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 30 Jun 2026 (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 this study is to evaluate the effectiveness of collagen mesotherapy in the treatment of chronic low back pain (CLBP) in the lumbosacral spine.
Mesotherapy is expected to reduce pain in the lumbosacral region, decrease soft tissue tension (including muscles, fascia, and ligaments), improve spinal mobility, and support subsequent physiotherapy.
A total of five treatment sessions will be performed at weekly intervals.
During each session, approximately 20 intradermal microinjections will be administered into the paraspinal soft tissues of the lumbosacral region. Participants will receive injections of either type I tropocollagen, 1% lignocaine (lidocaine), or a combination of both, with a volume of 0.1 mL per injection.
Detailed description
CLBP is a prevalent musculoskeletal condition associated with functional impairment and reduced quality of life. Conservative management includes pharmacotherapy, physiotherapy, and minimally invasive interventions.
Mesotherapy is a technique involving multiple intradermal microinjections of active substances into the affected area. Collagen-based preparations, such as type I tropocollagen, are hypothesized to support tissue regeneration and reduce pain through structural and biochemical mechanisms. Lignocaine is a local anesthetic widely used for pain control.
The objective of this study is to compare the effectiveness of collagen mesotherapy with lignocaine and combination therapy in patients with chronic low back pain localized to the lumbosacral region.
Participants will be randomly assigned to one of three parallel groups: type I tropocollagen, 1% lignocaine, or a combination of both. Each participant will undergo five treatment sessions performed once weekly and will remain in the assigned group throughout the study period.
During each session, approximately 20 intradermal microinjections will be injected into the paraspinal soft tissues of the lumbosacral region. Each injection will contain 0.1 mL of the assigned intervention: type I tropocollagen, 1% lignocaine, or their combination.
The effects of the interventions on pain intensity, functional status, and mobility of the lumbosacral spine will be evaluated using validated outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel groups: type I tropocollagen, 1% lignocaine, or a combination of both. Each participant will receive five treatment sessions performed once weekly and will remain in the assigned group throughout the study period. Masking is ensured by preparation of study substances by an independent physician who is not involved in treatment administration. The prepared substances are provided in identical syringes, and the preparations are visually indistinguishable. Both participants and the treating physician remain masked to group allocation.
| Arm | Type | Receives |
|---|---|---|
| Tropocollagen Group | Active comparator | Other: Tropocollagen type IParticipants receive type I tropocollagen administered using mesotherapy. Treatment consists of approximately 20 intradermal microinjections of 0.1 mL each injected into the paraspinal soft tissues of the lumbosacral region. The procedure is performed once weekly for five consecutive weeks. |
| Lignocaine Group | Active comparator | Drug: Lignocaine 1% concentration solutionParticipants receive 1% lignocaine administered using mesotherapy. Treatment consists of approximately 20 intradermal microinjections of 0.1 mL each injected into the paraspinal soft tissues of the lumbosacral region. The procedure is performed once weekly for five consecutive weeks. |
| Tropocollagen + Lignocaine Group | Active comparator | Other: Tropocollagen type I, Drug: Lignocaine 1% concentration solutionParticipants receive a combination of type I tropocollagen and 1% lignocaine administered using mesotherapy. Treatment consists of approximately 20 intradermal microinjections of 0.1 mL each injected into the paraspinal soft tissues of the lumbosacral region. The procedure is performed once weekly for five consecutive weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age between 18 and 65 years Chronic localized pain in the lumbosacral spine without radicular symptoms or radiation to the lower limbs Recent spinal imaging (X-ray, computed tomography (CT), or magnetic resonance imaging (MRI)) performed within the last 6 months confirming the diagnosis
Key exclusion criteria (1 listed)
- Known allergy to collagen or lignocaine Active malignancy Autoimmune diseases Skin lesions in the lumbosacral region Active infection Lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tropocollagen type IType I tropocollagen is administered using mesotherapy as approximately 20 microinjections of 0.1 mL each into the paraspinal soft tissues of the lumbosacral region. The treatment is performed once weekly for five consecutive weeks | Other | Tropocollagen + Lignocaine Group, Tropocollagen Group |
| Lignocaine 1% concentration solutionLignocaine 1% is administered using mesotherapy as approximately 20 microinjections of 0.1 mL each into the paraspinal soft tissues of the lumbosacral region. The treatment is performed once weekly for five consecutive weeks. | Drug | Lignocaine Group, Tropocollagen + Lignocaine Group |
Primary outcome
Change in pain intensity assessed using the Numeric Rating Scale (NRS)
Time frame: From baseline to 3 months after treatment completion, including weekly assessments during the 5-week treatment period and assessment 1 week after treatment completion.
Pain intensity will be assessed using the Numeric Rating Scale (NRS), an 11-point patient-reported scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain. Assessments will be performed at baseline, during each weekly treatment session, one week after completion of treatment, and three months after completion of treatment. Changes in NRS scores from baseline to each follow-up time point will be evaluated.
Change in pain severity assessed using the Laitinen Pain Scale
Time frame: From baseline to 3 months after treatment completion, including weekly assessments during the 5-week treatment period and assessment 1 week after treatment completion.
Pain severity will be assessed using the Laitinen Pain Scale, a multidimensional scale evaluating pain intensity, pain frequency, analgesic use, and physical activity. The total score ranges from 0 to 16. Higher scores indicate worse pain severity and functional impairment. Assessments will be performed at baseline, during each weekly treatment session, one week after completion of treatment, and three months after completion of treatment. Changes in Laitinen Pain Scale scores from baseline to each follow-up time point will be evaluated.
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 30 Jun 2026.
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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.
National Institute of Geriatrics, Rheumatology and Rehabilitation
Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tropocollagen type I and Lignocaine 1% concentration solution in people with Chronic Low Back Pain (Non-specific, Uncomplicated), 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 30 Jun 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity assessed using the Numeric Rating Scale (NRS) (time frame: From baseline to 3 months after treatment completion, including weekly assessments during the 5-week treatment period and assessment 1 week after treatment completion.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2026.