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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peloid Therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local Peloid Therapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Jaw Function Score at Week 2 | 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. | Baseline and Week 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Faruk Kadri Bakkal, MD, Asistant Professor | Contact | +90 276 224 00 00 | 4238 | fkbakkal@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uşak University Faculty of Medicine | Recruiting | Uşak | Merkez | 64420 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39791447 | Background | 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. | |
| 24482784 | Background | 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. |
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Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations. De-identified aggregate data may be available from the corresponding investigator upon reasonable request.
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| D010146 | Pain |
| D004433 | Earache |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| 37963787 | Background | 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. |
| 11296048 | Background | 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. |
| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |