Clinical trial NCT04087005: Efficacy and Safety of JHG002 for Chronic Temporomandibular Joint Dysfunction: A Multicenter Randomized Controlled Trial
Official title: Efficacy and Safety of JHG002(Hominis Placenta, 紫河車) Therapy for Chronic Temporomandibular Joint Dysfunction: A Multicenter Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorder
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 82
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a 2-arm parallel, assessor blinded, multi-centre, randomised controlled trial.

Detailed description: From 2 hospitals of Korean medicine, we will enrol 82 chronic TMD patients in Axis 1, Group Ⅰ according to RDC/TMD diagnostic criteria, and randomly allocate 41 patients each to an HPP group and a physical therapy (PT) group. Treatment will be administered in 10 rounds, after which there will be 4 follow-up visits (6, 9, 13, and 25 weeks from baseline). The primary end point is 6 weeks after baseline, and the primary outcome is the difference in Visual analogue scale (VAS) score for temporomandibular pain between baseline and Week 6. Secondary outcomes will be Numeric rating scale (NRS) scores for temporomandibular pain and discomfort, temporomandibular joint range of motion, Korean version of Beck's Depression Index-Ⅱ(K-BDI-II), Jaw Functional Limitation Scale (JFLS), Patien Global Impression of Change(PGIC), and quality of life. Using data on adverse events and cost-effectiveness in the two groups, we will perform a safety assessment and a cost-effectiveness analysis (economic assessment).

Eligibility 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:

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 disease 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 AST (GOT) or ALT (GPT) 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 are unable to receive pharmacopuncture due to e.g., inflammation or a wound at the relevant acupoints
17. Other patients whose participation in the trial is judged by a researcher to be problematic

Primary outcomes:
measure: The difference in visual analogue scale (VAS) of temporomandibular pain
timeFrame: Week 6
Secondary outcomes:
measure: Numeric rating scale (NRS) of TMJ pain and discomfort
timeFrame: Week 6
measure: TMJ range of motion
timeFrame: Week 6
measure: Korean version of Beck's Depression Index-Ⅱ (K-BDI-Ⅱ)
timeFrame: Week 6
measure: Jaw Functional Limitation Scale (JFLS)
timeFrame: Week 6
measure: Patient Global Impression of Change (PGIC)
timeFrame: Week 6
measure: The five level version of EuroQol-5 Dimension (EQ-5D-5L)
timeFrame: Week 6
measure: SF-12
timeFrame: Week 6
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
state: Gangnam-Gu
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
Study officials:
affiliation: Jaseng Hospital of Korean Medicine
name: In-Hyuk Ha
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim J, Park KS, Lee YJ, Kim KW, Cho JH, Ha IH. Efficacy, safety, and economic assessment of hominis placental pharmacopuncture for chronic temporomandibular disorder: a protocol for a multicentre randomised controlled trial. Trials. 2020 Jun 15;21(1):525. doi: 10.1186/s13063-020-04442-8.