Меню
Идёт набор NCT07576582

Peloid Therapy in Temporomandibular Joint Dysfunction

Без фазы С лечением Temporomandibular Disorders (TMDs) Pain Otalgia

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: Local Peloid Therapy.
Кому может быть актуально
Состояния в реестре: Temporomandibular Disorders (TMDs), Pain, Otalgia. Базовые параметры: 18 лет — 65 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

The Effect of Peloid Therapy on Pain and Functional Outcomes in Patients With Temporomandibular Joint Dysfunction

Обзор

This prospective, single-group clinical study will evaluate whether local peloid therapy improves pain and jaw function in adults with temporomandibular joint dysfunction. Participants will receive peloid therapy applied to the temporomandibular joint region and masticatory muscles for 20 minutes per session, 5 days per week, for 2 weeks. Pain and functional outcomes will be measured at baseline and at the end of treatment using validated clinical scales, including the Jaw Functional Limitation Scale-8, visual analog scale pain scores, Fonseca index, maximum mouth opening, and secondary otalgia assessment.

Подробное описание

Temporomandibular joint dysfunction is associated with pain, impaired chewing, restricted jaw function, and, in some patients, referred otalgia. Conservative treatment options are commonly used as first-line management, but the clinical evidence for some physical therapy modalities remains limited.

Peloid therapy is a local thermotherapeutic intervention used in balneotherapy and physical medicine. It may provide analgesic and muscle-relaxing effects through superficial heat and local tissue responses. However, prospective data evaluating its clinical effect in temporomandibular joint dysfunction are limited.

This study is designed to assess changes in jaw-related functional limitation and pain after a standardized 2-week course of local peloid therapy in adults diagnosed with temporomandibular joint dysfunction. Functional status, pain intensity, mouth opening, symptom severity, and secondary otalgia will be assessed before and after treatment using standardized clinical measures.

The study may provide additional evidence on the role of peloid therapy as a conservative supportive treatment option for temporomandibular joint dysfunction.

Вмешательства

  • Другое Local Peloid Therapy
    Participants will receive local peloid therapy applied externally over the temporomandibular joint region and adjacent masticatory muscles. The treatment will be delivered as 10 sessions over 2 weeks, with 5 sessions per week. Each session will last 20 minutes. Peloid therapy will be administered by a trained investigator according to the study protocol.

Первичные конечные точки

  • Change in Jaw Function Score at Week 2 [Срок оценки: Baseline and Week 2]

Критерии участия

Критерии включения

  • Age between 18 and 65 years
  • Diagnosis of temporomandibular joint dysfunction based on DC/TMD criteria
  • Presence of TMJ-related pain for at least 4 weeks
  • Baseline pain intensity ≥3 on a 0-10 visual analog scale
  • Ability to provide written informed consent

Критерии исключения

  • History of temporomandibular joint trauma, tumor, active infection, or acute inflammation
  • Previous temporomandibular joint surgery
  • Presence of systemic inflammatory rheumatologic disease
  • Pregnancy
  • Open wound, active dermatitis, or skin condition preventing peloid application at the treatment site
  • Injection therapy (e.g., botulinum toxin) or regular physical therapy for TMJ within the past 3 months
  • Any clinical or behavioral condition that may interfere with study compliance

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Uşak University Faculty of Medicine — Uşak

Публикации

  • Sun R, Liu T, Liu Y, Zhang S, Yue Y, Jiang N, Zhang L, Xiong X. Simplified Jaw Functional Limitation Scale for Temporomandibular Disorders: Psychometric Evaluation. Oral Dis. 2025 Jun;31(6):1854-1860. doi: 10.1111/odi.15253. Epub 2025 Jan 10. PMID 39791447
  • Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF PMID 24482784
  • Ramazani F, Szalay-Anderson C, Batista AV, Park P, Hwang E, Chau J, Lui J. Referred otalgia: Common causes and evidence-based strategies for assessment and management. Can Fam Physician. 2023 Nov;69(11):757-761. doi: 10.46747/cfp.6911757. PMID 37963787
  • Kuttila SJ, Kuttila MH, Niemi PM, Le Bell YB, Alanen PJ, Suonpaa JT. Secondary otalgia in an adult population. Arch Otolaryngol Head Neck Surg. 2001 Apr;127(4):401-5. doi: 10.1001/archotol.127.4.401. PMID 11296048

Идентификаторы

NCT: NCT07576582 · PT-TMJ

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗