Evaluation of the Effectiveness and Safety of Mesotherapy in the Treatment of Chronic Low Back Pain Syndrome

NCT07675304 | Recruiting Early Phase 1

• 1 other identifier: S/34/2026/ZSchNR
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Chronic Low Back Pain (Non-specific, Uncomplicated)

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From baseline to 3 months after treatment completion, including weekly assessments during the 5-week treatment period and assessment 1 week after treatment completion.

Study Arms (3)

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.

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.

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

Other: Tropocollagen type I; Drug: Lignocaine 1% concentration solution

Interventions

Tropocollagen type I OTHER

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

Tropocollagen + Lignocaine Group; Tropocollagen Group

Lignocaine 1% concentration solution DRUG

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.

Lignocaine Group; Tropocollagen + Lignocaine Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known allergy to collagen or lignocaine Active malignancy Autoimmune diseases Skin lesions in the lumbosacral region Active infection Lack of informed consent

Sponsors & Collaborators

• National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland: lead

Study Sites (1)

National Institute of Geriatrics, Rheumatology and Rehabilitation

Warsaw, Poland

RECRUITING

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: June 30, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-05

Locations

PL (1)