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Идёт набор NCT07321483

Reflex Therapy of Temporomandibular Dysfunctions

Без фазы С лечением Temporomandibular Joint Dysfunction; Myofascial Pain Syndrome; Orofacial Pain; Musculoskeletal Disorders

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: Dry needling, Standard rehabilitation.
Кому может быть актуально
Состояния в реестре: Temporomandibular Joint Dysfunction; Myofascial Pain Syndrome; Orofacial Pain; Musculoskeletal Disorders. Базовые параметры: от 18 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
Чехия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Evaluation of the Therapeutic Efficacy of Reflex Therapy Using Dry Needling in Patients With Functional Temporomandibular Pain Syndrome: A Prospective, Randomized, Controlled Pilot Study.

Обзор

This study aims to evaluate the effectiveness of dry needling in patients with functional temporomandibular pain syndrome by comparing standard rehabilitation therapy alone with therapy combined with dry needling to reduce pain, improve jaw function and enhance quality of life.

Подробное описание

This prospective, randomized, controlled pilot study aims to evaluate the therapeutic effects of dry needling in patients with functional temporomandibular pain syndrome. A total of 100 participants will be randomly assigned to two groups: an experimental group receiving standard rehabilitation combined with dry needling therapy, and a control group undergoing standard rehabilitation only. The intervention program will consist of ten outpatient rehabilitation sessions conducted over five weeks.

Outcome measures will include pain intensity (Visual Analogue Scale, VAS), temporomandibular joint range of motion, presence of joint sound phenomena, and quality of life assessed using the World Health Organization Quality of Life - BREF questionnaire (WHOQOL-BREF questionnaire). Measurements will be collected at baseline, immediately after the first therapy session, and upon completion of the treatment cycle.

Descriptive statistics will be used for data analysis. The Shapiro-Wilk test will assess data normality. Between-group differences will be analyzed using parametric (t-test) or nonparametric (Mann-Whitney, Wilcoxon) tests, depending on data distribution. Correlation analyses will be performed using Pearson's or Spearman's correlation coefficients. Statistical significance will be set at p \< 0.05.

All statistical analyses will be conducted using IBM SPSS Statistics for Windows, version 29.0 (Armonk, NY, USA).

Вмешательства

  • Процедура Dry needling
    One dry needling intervention targeting trigger points in the masseter and temporalis muscles during the first treatment session
  • Процедура Standard rehabilitation
    The therapy will include mobilization, soft tissue relaxation techniques, and specific exercises focused on improving temporomandibular joint mobility and reducing muscle tension.

Первичные конечные точки

  • 1. Pain Intensity using the Visual Analogue Scale (VAS). [Срок оценки: Baseline (pre-intervention) Immediately after the first therapy session At completion of the treatment program (after 10 therapy sessions).]
Вторичные конечные точки (1)
  • Temporomandibular Joint (TMJ) Range of Motion, Joint Sound Phenomena and Quality of Life (WHOQOL-BREF) [Срок оценки: Baseline (pre-intervention) Immediately after the first therapy session At completion of the treatment program (after 10 therapy sessions)]

Критерии участия

Критерии включения

  • Diagnosed with functional temporomandibular pain syndrome without structural temporomandibular joint damage.
  • Aged ≥18 years.
  • Stable health condition suitable for outpatient rehabilitation.
  • Willingness to participate and ability to follow the therapeutic protocol.

Критерии исключения

  • Presence of degenerative, post-traumatic, or inflammatory changes in the temporomandibular joint.
  • Cognitive or psychiatric disorders limiting cooperation.
  • Lack of informed consent or non-compliance during treatment

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
Открытое
Основная цель
Лечение

Центры проведения

Чехия · 1 центр
  • Faculty of Health Sciences, Palacký University Olomouc, Czech Republic — Olomouc

Публикации

  • Quilghini C, Lefflot J, Buchholtz K. The effectiveness of physiotherapy for chronic headaches in patients with temporomandibular disorders: a systematic review. Front Rehabil Sci. 2025 Sep 23;6:1647927. doi: 10.3389/fresc.2025.1647927. eCollection 2025. PMID 41064810
  • Armijo-Olivo S, Pitance L, Singh V, Neto F, Thie N, Michelotti A. Effectiveness of Manual Therapy and Therapeutic Exercise for Temporomandibular Disorders: Systematic Review and Meta-Analysis. Phys Ther. 2016 Jan;96(1):9-25. doi: 10.2522/ptj.20140548. Epub 2015 Aug 20. PMID 26294683
  • Konečný P, Havlíčková J, Elfmark M, Tvrdý P, Hanáková D, Jureček M. Effects of Rehabilitation in Patients with Temporomandibular Joint Disorders. Rehabil. Fyz. Lek. (2007) 14: 95-100.

Идентификаторы

NCT: NCT07321483 · IGA_FZV_2025_015

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗