Effectiveness of the Fascial Distortion Model in Temporomandibular Disorders: A Randomized Sham-controlled Trial

Официальное название

Investigation of the Effectiveness of Manual Therapy Based on Fascial Distortion Model in Individuals With Temporomandibular Disorder: A Randomized Sham-controlled Trial

Обзор

The aim of the study was to investigate the effectiveness of Manual Therapy Based on the Fascial Distortion Model in individuals with temporomandibular disorders compared to sham control. Individuals diagnosed with temporomandibular disorder will be randomly assigned to groups as Group 1 (Manual Therapy Based on Fascial Distortion Model) and Group 2 (Sham Control). Head posture, cervical and temporomandibular joint range of motion, cervical muscle performance, pain intensity, pressure pain thresholds, temporomandibular disorder severity, disability, dysfunction, health-related quality of life, kinesiophobia, and central sensitization will be assessed.

Подробное описание

Interventions are needed to address head posture, cervical and temporomandibular joint range of motion, cervical muscle performance, pain intensity, pressure pain thresholds, temporomandibular disorder severity, disability, dysfunction, health-related quality of life, kinesiophobia, and central sensitization in individuals with temporomandibular disorder (TMD). This study aims to examine the effectiveness of Manual Therapy Based on the Fascial Distortion Model in individuals with TMDs compared to sham control over a 4-week period. Individuals with TMD will be randomized into Group 1 (Fascial Distortion Model-based Manual Therapy) or Group 2 (Sham Control). Interventions will be conducted once a week in a clinical setting. Head posture will be measured by lateral photogrammetry, cervical range of motion will be measured by an inclinometer, temporomandibular range of motion will be measured by a vernier caliper, cervical muscle performance will be measured by Cervical Spine Functional Strength Test, and pressure pain threshold will be measured by an algometer. Pain intensity will be assessed using the Graded Chronic Pain Scale (Revised) and the Short-Form McGill Pain Questionnaire. TMD severity will be assessed using the Fonseca Anamnestic Index. Mandibular Function Impairment Questionnaire will be used to assess dysfunction. Disability will be evaluated using the Craniofacial Pain and Disability Inventory. Health-related quality of life will be assessed using Short Form-36. Kinesiophobia will be assessed with the Tampa Kinesiophobia Scale; central sensitization will be assessed with the Central Sensitisation Inventory.

All outcomes will be measured at baseline and end of the study, while pain intensity and pressure pain thresholds will also undergo intermediate assessments (2nd and 3rd week).

Вмешательства

• Процедура Fascial Distortion Model
  The following techniques were used on the cranial and cervical areas during therapy: Trigger band technique, herniated trigger point technique, continuum technique, folding technique, cylinder technique, and tectonic technique.
• Процедура Sham treatment
  The techniques in the therapy will be applied by imitating the techniques in the therapy for the fascial distortions determined according to the Manual Therapy Based on the Fascial Distortion Model.

Первичные конечные точки

• Head posture [Срок оценки: From enrollment to the end of treatment at 4th week]
• Cervical range of motions [Срок оценки: From enrollment to the end of treatment at 4th week]
• Temporomandibular range of motions [Срок оценки: From enrollment to the end of treatment at 4th week]
• Cervical muscle performance [Срок оценки: From enrollment to the end of treatment at 4th week]
• Pressure pain threshold [Срок оценки: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.]
• Pain intensity in the last week [Срок оценки: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.]
• Chronic pain intensity [Срок оценки: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.]
• Temporomandibular disorders severity [Срок оценки: From enrollment to the end of treatment at 4th week]
• Dysfunction [Срок оценки: From enrollment to the end of treatment at 4th week]
• Disability [Срок оценки: From enrollment to the end of treatment at 4th week]

Критерии участия

Критерии включения

• Having temporomandibular joint complaints and being diagnosed with temporomandibular disorder according to the Diagnostic Criteria for Temporomandibular Disorders Axis I
• Understand and be willing to answer assessment questions
• A temporomandibular joint complaint for the last three months
• Pain in the jaw, face or neck

Критерии исключения

• Has a systemic disease (neurological, rheumatologic, oncologic, etc.) that may affect the temporomandibular joint, cervical spine and/or assessment
• Any history of trauma that may have affected the cranio-cervico-facial region
• Having undergone any surgical intervention in the cranio-cervico-facial region within the last six months
• Receiving surgical treatment, medical treatment, splint therapy or physiotherapy for temporomandibular disorder in the last month
• Radiotherapy in the head and neck region
• Pregnancy or breastfeeding
• Exercise therapy for craniocervical posture for the last month

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

Turkey (Türkiye) · 1 центр

• Karabük University — Merkez

Идентификаторы

NCT: NCT06627855 · 2024/1627

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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