Evaluation of the Effectiveness and Safety of Mesotherapy in the Treatment of Chronic Low Back Pain Syndrome
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.
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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Frühphase 1
Kontakte und Standorte
Studienorte
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Warsaw, Polen
- Rekrutierung
- National Institute of Geriatrics, Rheumatology and Rehabilitation
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Kontakt:
- Kamil Koszela, PhD
- Telefonnummer: +48 601441115
- E-Mail: kamil.aikido@interia.pl
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Kontakt:
- Agnieszka Guz, MD
- Telefonnummer: +48 604638529
- E-Mail: agnieszkaa.guz@gmail.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver Komparator: Tropocollagen Group
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.
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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
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Aktiver Komparator: Lignocaine Group
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.
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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.
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Aktiver Komparator: Tropocollagen + Lignocaine Group
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
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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% 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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Change in pain intensity assessed using the Numeric Rating Scale (NRS)
Zeitfenster: From baseline to 3 months after treatment completion, including weekly assessments during the 5-week treatment period and assessment 1 week after treatment completion.
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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.
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From baseline to 3 months after treatment completion, including weekly assessments during the 5-week treatment period and assessment 1 week after treatment completion.
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Change in pain severity assessed using the Laitinen Pain Scale
Zeitfenster: From baseline to 3 months after treatment completion, including weekly assessments during the 5-week treatment period and assessment 1 week after treatment completion.
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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.
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From baseline to 3 months after treatment completion, including weekly assessments during the 5-week treatment period and assessment 1 week after treatment completion.
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- S/34/2026/ZSchNR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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