Otalgia, Pain, Temporomandibular Disorders (TMDs)
Conditions
Keywords
TMJ Disorders, pain, otalgia
Brief 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.
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.
Interventions
OTHERLocal 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.
Sponsors
Uşak University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTFaruk Kadri Bakkal, MD, Asistant Professor
Outcome results
None listed