None listed
Conditions
Interventions
Procedure/Surgery : JHG002 with a disposable syringe (0.5ml) will be administerd directly into the designated sites, using a standardized method. The HPP group will receive 2 sessions/week of HPP for
Sponsors
Jaseng Medical Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with unilateral or bilateral TMJ pain (2) Patients with VAS = 40mm for the area showing TMJ pain (for patients with bilateral pain, the side with worse pain) (3) Patients complaining of persistent of sporadic TMJ pain for at least 3 months (4) Patients diagnosed as myofascial TMD (Axis I: Group 1) based on the RDC/TMD diagnostic criteria [5] (5) Patients aged 19–70 years on the date they sign the consent form (6) Patients who provide consent to participate in the trial and return the informed consent form
Exclusion criteria
Exclusion criteria: (1) Patients whose current pain episode developed or worsened because of a road traffic accident or traumatic injury (2) Patients diagnosed in Group 2 or 3 of Axis I based on the RDC/TMD diagnostic criteria (3) Patients who have undergone surgery related to the TMJ (4) Patients with other chronic diseases that could interfere with interpretation of the treatment effects or outcomes (e.g., rheumatoid arthritis, neoplastic disease, stroke, or myocardial infarction) (5) Patients currently taking steroids, immunosuppressants, psychiatric drugs, or other drugs that could affect the study results (6) Patients who have received HPP within the last month, or who have taken drugs that could affect pain, such as NSAIDs, within the last week (7) Pregnant or breastfeeding women (8) Patients who have finished participation in another clinical trial within the last month, who participated in another trial within 6 months of selection, or who are planning to participate in another clinical trial during the follow-up period (9) Patients with a history of hypersensitivity after HPP (10) Diabetic patients with uncontrolled blood glucose (fasting blood glucose = 180mg/dl) (11) Patients with aspartate aminotransferase or alanine aminotransferase at least 2 times the normal range at the testing centre (12) Patients with creatinine at least 2 times the normal range at the testing centre (13) Patients suspected to have organic disease (14) Patients with cardiac, hepatic, renal, or other serious complications (15) Patients with psychogenic disease (16) Patients who is taking warfarin (17) Patients with pacemaker (18) Patients who are unable to receive pharmacopuncture due to e.g., inflammation or a wound at the relevant acupoints (19) Patients whose participation in the trial is judged by a researcher to be problematic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analogue scale (VAS) of temporomandibular pain | — |
Secondary
| Measure | Time frame |
|---|---|
| Temporomandibular joint pain & bothersome Numeric Rating Scale (NRS);Vertical Range of Motion, pain-free;Mandibular excursive movement;Korean version of Beck’s Depression Index-? (K-BDI-?);Jaw Functional Limitation Scale (JFLS);Patient Global Impression of Change (PGIC);Quality of life (SF-12, EQ-5D-5L);Drug consumption;Credibility and Expectancy | — |
Countries
Korea, Republic of
Contacts
Public ContactKyoung Sun Park
Jaseng Medical Foundation
Outcome results
None listed