Peloid Therapy in Temporomandibular Joint Dysfunction
The Effect of Peloid Therapy on Pain and Functional Outcomes in Patients With Temporomandibular Joint Dysfunction
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Faruk Kadri Bakkal, MD, Asistant Professor
- 電話番号：4238 +90 276 224 00 00
- メール：fkbakkal@gmail.com
研究場所
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Merkez
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Uşak、Merkez、トルコ（Türkiye）、64420
- 募集
- Uşak University Faculty of Medicine
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コンタクト：
- Faruk Kadri Bakkal
- 電話番号：4238 +90 276 224 00 00
- メール：fkbakkal@gmail.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
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
Exclusion Criteria:
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Peloid Therapy
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Jaw Function Score at Week 2
時間枠：Baseline and Week 2
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Jaw function will be assessed using the Jaw Functional Limitation Scale-8 (JFLS-8).
This is a patient-reported questionnaire that measures limitation in jaw activities such as chewing, speaking, and mouth opening.
The total score ranges from 0 to 10, where 0 indicates no functional limitation and 10 indicates the highest level of limitation.
The primary outcome will be the change in JFLS-8 total score from baseline to Week 2.
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Baseline and Week 2
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- 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; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- PT-TMJ
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
痛みの臨床試験
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Bingol UniversityAtaturk Universityまだ募集していません術前不安 | 恐れ | PAİN
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Dexa Medica Group完了
Local Peloid Therapyの臨床試験
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Universitätsklinikum Hamburg-EppendorfCytoSorbents, Inc募集
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Universitätsklinikum Hamburg-Eppendorf完了