A comparative study of the Influence of Wearing an Adjunctive Intraoral Balance Appliance (IBA) in the Usual Care of Korean medicine for patients with Chronic Temporomandibular Joint Disorders
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0008906
- Lead Sponsor
- Kyung Hee University Oriental Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 76
1. patients with unilateral or bilateral TMJ pain
2. Patients with an NRS = 4 at the site of jaw joint pain (based on the site of greatest pain for patients with bilateral pain)
3. Patients with ongoing, intermittent TMJ pain for more than 3 months
4. Patients diagnosed with myalgia TMD according to DC/TMD diagnostic criteria.
5. Patients who are at least 19 years of age and no older than 70 years of age as of the date of signing the informed consent form.
6. Patients who agree to participate in the study and have provided informed consent.
1. the current pain episode was caused or aggravated by a motor vehicle accident or traumatic injury
2. TMJ or facial pain that does not qualify as myalgia TMD according to DC/TMD diagnostic criteria
3. patient who underwent surgery related to the TMJ
4. patient who have other medical conditions (e.g., rheumatoid arthritis, tumor disease, stroke, and myocardial infarction) that may interfere with treatment effectiveness or interpretation of results
5. currently taking steroids, immunosuppressants, psychiatric medications, or other medications that may affect the results of the study
6. patient who have taken medications that may affect pain, such as non-steroidal anti-inflammatory drugs, within the past week, or have had orthodontic appliances applied in the past 2 weeks, regardless of the disorder.
7. For women of childbearing age, planning to become pregnant or currently breastfeeding
8. participated in another clinical study within 1 month prior to the date of selection or plans to participate in another clinical study during the participation and follow-up period from the date of selection.
9. Other conditions that make it difficult to participate in the study as judged by the investigator.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method temporomandibular joint pain NRS
- Secondary Outcome Measures
Name Time Method maximum mouth opening;Graded chronic pain scale(GCPS) - 1month version;Jaw functional limitation scale(JFLS);patient health questionnaire-9(PHQ-9);EQ-5D-5L;Patient global impression of change (PGIC);Credibility and expectancy;Patient satisfaction;Adverse event