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Набор скоро начнётся NCT06595017

Lidocaine Versus Magnesium Sulphate in Management of Myofascial Pain Dysfunction Syndrome

Фаза II С лечением Myofascial Pain Dysfunction Syndrome

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: Magnesium sulphate, Lidocaine (drug), Saline.
Кому может быть актуально
Состояния в реестре: Myofascial Pain Dysfunction Syndrome. Базовые параметры: 18 лет — 55 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
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Официальное название

Evaluation of the Effect of Magnesium Sulfate Injection in Comparison to Lidocaine for Management of Myofascial Pain Dysfunction Syndrome: a Randomized Controlled Clinical Trial

Обзор

The goal of this clinical trial is to investigate the effectiveness of Magnesium Sulphate in the management of myofascial pain dysfunction syndrome in comparison to Lidocaine and Saline. A total of 75 patients suffering from myofascial pain dysfunction syndrome will be assigned into one of three groups, each with 25 patients. Group A: (Saline) includes patients enrolled for Saline injection into the trigger points. Group B: (Magnesium Sulphate) includes patients enrolled for Magnesium Sulphate injection into the trigger points. Group C: (Lidocaine) includes patients who will be enrolled for Lidocaine injection into the trigger points The primary outcome that will be investigated is (pain with a visual analogue score), and secondary outcomes will be (maximum mouth opening between edges of upper and lower incisors with millimeters, electrical activity with Electromyography, and quality of life assessed using the Oral Health Impact Profile questionnaire) The outcomes will be assessed pre-injection, 1month after injection, 3months after injection, and 6 months after injection

Вмешательства

  • Препарат Magnesium sulphate
    After localization of the trigger points, the skin was disinfected with alcohol, the tight muscle band was grabbed between two fingers, and a 30-gage 3/4-inch needle was introduced 1-2 cm away from the trigger points at a 30º angle to the skin. Negative aspiration was performed and each trigger point was injected with 2 ml of magnesium sulphate
  • Препарат Lidocaine (drug)
    After localization of the trigger points, the skin was disinfected with alcohol, the tight muscle band was grabbed between two fingers, and a 30-gage 3/4-inch needle was introduced 1-2 cm away from the trigger point at a 30º angle to the skin. Negative aspiration was performed and each trigger point was injected with 2 ml of Lidocaine
  • Препарат Saline
    After localization of the trigger points, the skin was disinfected with alcohol, the tight muscle band was grabbed between two fingers, and a 30-gage 3/4-inch needle was introduced 1-2 cm away from the trigger point at a 30º angle to the skin. Negative aspiration was performed and each trigger point was injected with 2 ml of Saline

Первичные конечные точки

  • Pain score [Срок оценки: At interval pre-injection and 1, 3, and 6 months after injection.]
Вторичные конечные точки (3)
  • The maximum mouth opening [Срок оценки: At interval pre-injection and 1, 3, and 6 months after injection.]
  • Electrical activity [Срок оценки: At interval pre-injection and 1, 3, and 6 months after injection.]
  • Quality of life [Срок оценки: At interval pre-injection and 1, 3, and 6 months after injection.]

Критерии участия

Критерии включения

  • Age Limitations: Participants must be between 18 and 55 years old.
  • Chronic Pain Diagnosis: Individuals must have a diagnosis of chronic myofascial pain dysfunction syndrome (MPDS) affecting the face muscles, neck, shoulder, or upper back for a duration exceeding three months.
  • Trigger Point Recognition: Patients must show awareness of their pain when pressure is applied to identified myofascial trigger points, in accordance with established diagnostic guidelines.
  • Consent to Participate: Willingness to provide informed consent and engage in all aspects of the study.

Критерии исключения

  • Previous Treatments: A history of receiving dry needling or pulsed radiofrequency therapy, or currently participating in other pain management treatments.
  • Recent Injury or Surgery: Any recent trauma, surgical procedures, or infections in the affected area within the past six months.
  • Medication Interference: Current or recent use of moderate to strong analgesics (e.g., tramadol, morphine) that could influence pain assessment.
  • Severe Health Conditions: Individuals with significant systemic illnesses (e.g., severe liver or kidney disease), blood clotting disorders, rheumatoid arthritis or epilepsy.
  • Mental Health: Presence of current psychiatric disorders, cognitive impairments, or inability to comply with the study protocol.

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06595017 · 1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗