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Набор скоро начнётся NCT07531654

Comparative Effectiveness of Standard and Modified Laser Therapy in Myofascial Pain Management.

Без фазы 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: High Level Laser Therapy, Low Level Laser Therapy.
Кому может быть актуально
Состояния в реестре: Myofascial Pain Dysfunction Syndrome. Базовые параметры: Без ограничений · 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
Египет
Следующий шаг
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Официальное название

Comparative Effectiveness of Standard and Modified Laser Therapy in Myofascial Pain Management: A Randomized Clinical Trial

Обзор

The goal of this clinical trial is to evaluate and compare the effectiveness of modified laser therapy versus conventional laser therapy in managing pain and mandibular function in patients with chronic myofascial pain syndrome involving the masseter muscles. The main questions it aims to answer are: 1. Does high-intensity laser therapy (HILT) provide a greater reduction in pain intensity on a numerical rating scale (NRS) compared to low-level laser therapy (LLLT)? 2. Does high-intensity laser therapy (HILT) provide greater improvement in functional outcomes, specifically maximal incisal opening, compared to low-level laser therapy (LLLT)? Comparison Group: Researchers will compare the experimental group receiving High-Intensity Laser Therapy (HLLT) to a comparator group receiving Low-Level Laser Therapy (LLLT) to see if the modified high-intensity approach provides superior pain relief and improved mandibular movement. Participants will: 1. Be randomly assigned to either the HILT or LLLT treatment group. 2. Undergo 12 laser irradiation sessions delivered over one month. 3. Have laser energy applied directly to the trigger points of the masseter muscles during 5-minute sessions. 4. Attend follow-up assessments at each session, and at intervals of 1, 3, and 6 months. 5. Provide pain ratings using a numerical scale and have their maximal mouth opening measured by a caliper.

Вмешательства

  • Устройство High Level Laser Therapy
    Laser energy density of 3 KJ will be applied to the masseter muscles using an epic-x940 nm diode laser, with 12 irradiation sessions delivered over one month. The mode of laser was a continuous wave irradiation for 5 minutes, distance to Tissue\~1 cm, and the area of the laser delivery tip was 5 cm2. The trigger point was identified within the affected muscle.
  • Устройство Low Level Laser Therapy
    Laser energy density of 1.5 KJ will be applied to the masseter muscles using an epic-x940 nm diode laser (BioLase, USA), with 12 irradiation sessions delivered over one month. The mode of laser was a continuous wave irradiation for 5 minutes, distance to Tissue\~1 cm, and the area of the laser delivery tip was 5 cm2. The trigger point was identified within the affected muscle.

Первичные конечные точки

  • Pain Assessment [Срок оценки: Pain will be assessed using a numerical rating scale (NRS) at rest and during mouth opening at the following follow up time points: at each session, 1, 3 months and 6 months.]
Вторичные конечные точки (1)
  • Maximal incisal opening [Срок оценки: Maximal incisal opening is measured at each session, 1, 3 months and 6 months.]

Критерии участия

Критерии включения

  • Diagnosis of myofascial temporomandibular disorder following the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
  • Participants eligible for inclusion in this study must not have received any previous laser therapy for the management of myofascial pain dysfunction syndrome or temporomandibular disorders like pharmacological therapy, physical therapy, manual techniques, and trigger point injections.
  • No previous laser therapy for last 3 months.
  • Pain localized to the masseter muscles.
  • Pain lasting at least 3 months with a self-reported pain level of 6 or higher on a numerical rating scale (NRS).

Критерии исключения

1- Patients with TMJ pain, or those who had any previous treatment for TMD 2- Patients with any history of cervical or degenerative conditions, any surgery or trauma to the neck during last year 3- Previous treatment of MPDS during last year 4- Confirmed diagnosis of fibromyalgia or rheumatoid arthritis 5- Patients with dark skin tone or chubby face

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

Египет · 1 центр
  • Cairo University — Cairo

Идентификаторы

NCT: NCT07531654 · 2025/0081

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗