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Идёт набор NCT07675304

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

Ранняя фаза I С лечением Chronic Low Back Pain (Non-specific, Uncomplicated)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Tropocollagen type I, Lignocaine 1% concentration solution.
Кому может быть актуально
Состояния в реестре: Chronic Low Back Pain (Non-specific, Uncomplicated). Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Польша
Следующий шаг
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Официальное название

Evaluation of the Effectiveness and Safety of Mesotherapy in the Treatment of Chronic Low Back Pain Syndrome: a Randomized Study

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое Tropocollagen type I
    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
  • Препарат Lignocaine 1% concentration solution
    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.

Первичные конечные точки

  • Change in pain intensity assessed using the Numeric Rating Scale (NRS) [Срок оценки: 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 [Срок оценки: From baseline to 3 months after treatment completion, including weekly assessments during the 5-week treatment period and assessment 1 week after treatment completion.]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Польша · 1 центр
  • National Institute of Geriatrics, Rheumatology and Rehabilitation — Warsaw

Идентификаторы

NCT: NCT07675304 · S/34/2026/ZSchNR

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗