Collagen Mesotherapy for Chronic Low Back Pain in the Lumbosacral Region
Official title: Evaluation of the Effectiveness and Safety of Mesotherapy in the Treatment of Chronic Low Back Pain Syndrome: a Randomized Study
Run by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland · NCT07675304 · Data updated 2026-11-12
This study tests whether collagen mesotherapy, with or without lidocaine, can reduce pain and improve function in adults with chronic non-specific low back pain localized to the lumbosacral area.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland Research network |
| Drugs / interventions | radiation |
| Locations | 1 site (Warsaw) |
| Status | Recruiting |
| Started | May 6, 2026 |
| Main results expected | December 2026 |
| Study ends | March 2027 |
| Registry record updated | June 30, 2026 |
| Trial ID | NCT07675304 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-65 with chronic non-specific localized low back pain in the lumbosacral region, without radicular symptoms, and recent imaging confirming the diagnosis.
✕Probably not a fit
Patients with allergies to collagen or lidocaine, active infection or skin lesions at the injection site, autoimmune disease, or other exclusion criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants with chronic non-specific low back pain will be randomized to receive five weekly mesotherapy sessions in the paraspinal area, using either type I tropocollagen, 1% lidocaine, or a combination. Each session involves about 20 intradermal injections of 0.1 mL into the lumbosacral soft tissues, and outcomes will be measured for pain, function, and spine mobility. The study aims to compare the effectiveness and safety of collagen alone, lidocaine alone, and their combination over the treatment course. The trial is conducted at the National Institute of Geriatrics, Rheumatology and Rehabilitation in Warsaw, Poland, under a parallel-group design. Participants must be adults 18-65 years old with chronic localized lumbosacral pain and recent imaging confirming the diagnosis.
Why it matters
Potential benefit: If successful, patients could experience reduced pain and improved mobility, potentially enhancing quality of life and ability to participate in physical therapy.
How similar studies have gone: Prior approaches using intra- or intradermal collagen-based interventions have shown mixed results; this study tests a novel head-to-head comparison with lidocaine and their combination in CLBP.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: Known allergy to collagen or lignocaine Active malignancy Autoimmune diseases Skin lesions in the lumbosacral region Active infection Lack of informed consent
Where it's running
-
National Institute of Geriatrics, Rheumatology and Rehabilitation
Warsaw, Poland Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Immediate effects of manual vs verbal cues during movement training for chronic low back pain
In people with chronic non-specific low back pain, this trial tests whether manual cues or verbal cues during movement training produce better immediate movement control and related outcomes.
-
Telerehabilitation program to improve function in adults with chronic low back pain
This trial will test whether adding a 6-week online telerehabilitation program to usual care helps adults with chronic non-specific low back pain improve function, reduce pain, and increase treatment adherence.
-
Pain education with patient-led goal setting for adults with chronic low back pain
This will try pain education plus patient-led goal setting versus guideline-based written advice to see if it lowers pain and improves function in adults with chronic low back pain.
-
Exercise effect on the lumbar multifidus in back pain
This study tests whether a 12-week home rehab program can change ultrasound features of the lumbar multifidus and reduce pain in adults with chronic non-specific low back pain from multifidus injury.
-
McGill Stabilization Exercises vs Sahrmann Movement-Based Exercises for Chronic Low Back Pain
This trial tests whether McGill stabilization exercises or Sahrmann's movement-based exercises better reduce pain and improve motion and function in adults with chronic non-specific low back pain.
-
Whole-body vibration vs. Pilates for chronic low back pain in young adults
This trial tests whether whole-body vibration or Pilates, each with standard physiotherapy, better reduces pain and improves balance and function in adults with chronic non-specific low back pain.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.