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This study is a 2-arm parallel, assessor blinded, multi-centre, randomised controlled trial.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hominis placental pharmacopuncture | Experimental | The Hominis placental pharmacopuncture group will receive 10 sessions of Hominis placental pharmacopuncture at 2 sessions/week for 5 weeks. A trained doctor of Korean medicine with at least 2 years clinical experience will administer JHG002 pharmacopuncture with a disposable syringe (0.5ml) directly into the designated sites, using a standardized method. |
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| Transcutaneous electrical nerve stimulation | Active Comparator | The control group will receive 2 sessions/week of TENS for 5 weeks. A high-frequency, low-intensity stimulus of 50-100Hz and up to 15mA will be used, such that the patients feel a current but do not feel pain. At each treatment visit, a physiotherapist will administer the treatment to the bilateral temporomandibular joint for 15 minutes. Both centres will use the same TENS device-a BioTron-DX (D.M.C, Osan, South Korea). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hominis placental pharmacopuncture | Other | Hominis placental pharmacopuncture is human placental extract, which has been used in traditional Korean medicine to treat chronic diseases, including frailty, cough, anorexia, and fatigue, by enhancing the body's resistance. |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in visual analogue scale (VAS) of temporomandibular pain | The primary outcome is the difference in VAS for TMJ pain between baseline and the primary end point (Week 6). VAS is an assessment index in which the patient records their pain on a 100mm line from 'no pain' at one end, and 'the most severe pain imaginable' at the other end. | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric rating scale (NRS) of TMJ pain and discomfort | The extent of TMJ pain and discomfort in the last week will be assessed using NRS. NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participant is asked to report their TMJ pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In-Hyuk Ha | Jaseng Hospital of Korean Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jaseng Hospital of Korean Medicine | Seoul | Gangnam-Gu | 135-896 | South Korea | ||
| Kyung Hee University Hospital at Gangdong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39895393 | Derived | Kim D, Kim ES, Kim KW, Cho JH, Lee YJ, Ha IH. Cost-Effectiveness of Hominis Placenta Therapy for Chronic Temporomandibular Disorder: An Economic Evaluation Alongside a Pragmatic Randomised Controlled Trial. J Oral Rehabil. 2025 Jun;52(6):807-816. doi: 10.1111/joor.13932. Epub 2025 Feb 3. | |
| 38779539 | Derived |
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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| Week 6 |
| TMJ range of motion | A Therabite Range of Motion Ruler will be used to measure the range of TMJ mouth opening and excursive movement; the measurement method will follow the guidelines provided by the International RDC/TMD Consortium. | Week 6 |
| Korean version of Beck's Depression Index-Ⅱ (K-BDI-Ⅱ) | The BDI-Ⅱ is an index for diagnosing depression, consisting of 21 questions related to sadness, guilt, suicidal ideation, and loss of interest. In this study, we will use the K-BDI-II, which has been demonstrated to be valid and reliable by a Korean research group. | Week 6 |
| Jaw Functional Limitation Scale (JFLS) | The JFLS is an index assessing jaw function (mastication, mobility, and emotional and verbal expression) in the last month. The instrument consists of 20 questions, and each question is scored 0-10, where 0 points is 'no impairment' and 10 points is 'very severe impairment'. In this study, we will use the official Korean version of the 20-question JFLS, which has been demonstrated to be reliable. | Week 6 |
| Patient Global Impression of Change (PGIC) | The PGIC is an index that assesses improvements in functional limitation caused by TMD in 7 grades. Participants rate the improvement in functional limitations after treatment on a 7-point Likert scale (1=Very much improved, 4=No change, 7=Very much worse). This index was originally developed for use in Psychology, but is currently used in various other medical fields to assess improvements in pain. | Week 6 |
| The five level version of EuroQol-5 Dimension (EQ-5D-5L) | The EQ-5D-5L is a method of indirectly calculating the weights of certain health states for quality of life after a multidimensional investigation of health states, and is the most widely used instrument for this purpose. The EQ-5D-5L consists of 5 questions about current health state (mobility, self-care, usual activities, pain, anxiety/depression), and each question is scored on a 5-point Likert scale (1=no problems, 3=moderate problems, 5=severe problems). In this study, we will use the Korean version of the EQ-5D-5L, which has been demonstrated to be valid. | Week 6 |
| SF-12 | The SF-12 is a shortened version of the Short Form-36 Health Survey (SF-36), which is a widely used instrument to assess health-related quality of life. The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life. In this study, we will use the Korean version of the SF-12, which has been demonstrated to be reliable and valid. | Week 6 |
| Seoul |
| South Korea |
| Park KS, Kim ES, Kim KW, Cho JH, Lee YJ, Lee J, Ha IH. Effectiveness and safety of hominis placental pharmacopuncture for chronic temporomandibular disorder: A multi-center randomized controlled trial. Integr Med Res. 2024 Jun;13(2):101044. doi: 10.1016/j.imr.2024.101044. Epub 2024 Apr 20. |
| 32539850 | Derived | 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. |
| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |