Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders

Официальное название

Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders. A Randomized Controlled Trial

Обзор

The aim of this randomized controlled trial is to evaluate the effects of intraoral manual therapy versus extraoral manual therapy and compare them with a control group, in the management of patients with temporomandibular disorders regarding pain, strength, quality of life, disability and anxiety.

Вмешательства

• Другое Intraoral manual therapy
  Six intraoral manual therapy sessions based on ischemic compression and pain pressure release of the temporomandibular region muscles, applied bilateral.
• Другое Extraoral manual therapy
  Six extraoral manual therapy sessions based on ischemic compression, pain pressure release and pressure sliding of the temporomandibular region muscles, applied bilateral.
• Другое Exercise and counselling
  Information about etiology, contributing and related factors, natural history and prognostic of the pathology of temporomandibular disorders. Counselling based on: diet, habits like tabacism, stress and anxiety control, physical activity and awareness of dental clenching. Exercise daily program based on active and passive mobility of the temporomandibular joint, stretching exercises and self massage.

Первичные конечные точки

• Change in pain intensity [Срок оценки: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.]

Вторичные конечные точки (5)

• Change in pain pressure threshold [Срок оценки: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.]
• Change in range of movement of the temporomandibular joint [Срок оценки: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.]
• Change in quality of life [Срок оценки: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.]
• Change in disability [Срок оценки: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.]
• Change in anxiety [Срок оценки: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.]

Критерии участия

Критерии включения

• Unilateral temporomandibular pain for more than one month.
• Older than eighteen.
• No previous treatment to temporomandibular pain in the last 3 months.
• Diagnosed based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).

Критерии исключения

• Patients with cervical or cranial trauma or whiplash.
• Diagnosed with systemic disease, like rheumatoid arthritis or fibromyalgia.
• Diagnosed of any vascular or metabolic disease.
• Previous cervical or temporomandibular surgery.
• Dental, medicine or any physical therapy treatment in the last 3 months before the beginning of the interventions.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• University of Alcalá — Alcalá de Henares

Идентификаторы

NCT: NCT05167656 · CEID/2021/4/087

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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