None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : The test group will receive a combination of Korean medicine treatment and an adjunctive intraoral device, while the control group will receive Korean medicine trea
Sponsors
Kyung Hee University Oriental Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. participants 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. 2. participants with unilateral or bilateral TMJ pain 3. participants with an NRS = 4 at the site of TMJ pain (based on the site of greatest pain for patients with bilateral pain) 4. participants with persistent or intermittent TMJ pain for more than 3 months 5. participants diagnosed with TMD with myalgia according to DC/TMD diagnostic criteria. 6. participants who voluntarily agree to participate in the study and have provided written informed consent prior to study-related procedure.
Exclusion criteria
Exclusion criteria: 1. Current pain episode caused or exacerbated by a traumatic injury (ex. motor vehicle accident) 2. Indivisuals who do not meet the diagnosis of TMD with myalgia according to DC/TMD diagnostic criteria 3. participant who underwent surgery related to the TMJ 4. participant who have other medical conditions (e.g., rheumatoid arthritis, tumor, stroke, and myocardial infarction) that may interfere with efficacy of treatment or interpretation of results 5. Participants currently taking steroidal agents, immunosuppressants, psychiatric medications, and other medications that may affect the results of the study 6. Participants who have taken medications that may affect pain, such as non-steroidal anti-inflammatory drugs, within the past week, or have applied orthodontic appliances in the past 2 weeks, regardless of the condition. 7. Participants who are pregnant, planning to become pregnant or breastfeeding women 8. participated in another clinical study within 1 month prior to the date of enrollment, or plans to participate in another clinical study during the study participation and follow-up period. 9. Other conditions that make it difficult to participate in the study as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| temporomandibular joint pain and bothersomeness NRS | — |
Secondary
| Measure | Time frame |
|---|---|
| vertical ROM of temporomandibular joint;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 | — |
Countries
Korea, Republic of
Contacts
Public ContactSEYUN KIM
KyungHee University Medical Center
Outcome results
None listed