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
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