Peloid Therapy in Temporomandibular Joint Dysfunction

NCT07576582 — Not applicable, Recruiting, 40 participants, Uşak University

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

RegistryNCT07576582
StatusRecruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment40 (Estimated)
SponsorUşak University (Other)
ConditionsTemporomandibular Disorders (TMDs), Pain, Otalgia
InterventionsLocal Peloid Therapy (Other)
Datesstart 2026-04-01, primary completion 2027-01-01 (estimated), completion 2027-02-01 (estimated), first posted 2026-05-08, last updated 2026-07-02
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Temporomandibular Disorders (TMDs) All trials for Pain All trials of Local Peloid Therapy

-Summary

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.

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Peloid TherapyExperimentalOther: Local Peloid Therapy
  • 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.

+Outcome measures

Primary outcomes

  • Change in Jaw Function Score at Week 2 [Baseline and 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.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

FacilityCityCountryStatus
Uşak University Faculty of MedicineUşak, MerkezTurkey (Türkiye)Recruiting

+Publications

  • 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; 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. 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