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Efficacy and Safety of JHG002 for Chronic Temporomandibular Joint Dysfunction: A Multicenter Randomized Controlled Trial

Primary Purpose

Temporomandibular Disorder

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

hominis placental pharmacopuncture

About this trial

This is an interventional treatment trial for Temporomandibular Disorder

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with unilateral or bilateral TMJ pain
Patients with VAS≥40mm for the area showing TMJ pain (for patients with bilateral pain, the side with worse pain)
Patients complaining of persistent of sporadic TMJ pain for at least 3 months
Patients diagnosed as myofascial TMD (Axis I: Group 1) based on the RDC/TMD diagnostic criteria[5]
Patients aged 19-70 years on the date they sign the consent form
Patients who provide consent to participate in the trial and return the informed consent form

Exclusion Criteria:

Patients whose current pain episode developed or worsened because of a road traffic accident or traumatic injury
Patients diagnosed in Group 2 or 3 of Axis I based on the RDC/TMD diagnostic criteria
Patients who have undergone surgery related to the TMJ
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)
Patients currently taking steroids, immunosuppressants, psychiatric drugs, or other drugs that could affect the study results
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
Pregnant or breastfeeding women
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
Patients with a history of hypersensitivity after HPP
Diabetic patients with uncontrolled blood glucose (fasting blood glucose ≥180mg/dl)
Patients with AST (GOT) or ALT (GPT) at least 2 times the normal range at the testing centre
Patients with creatinine at least 2 times the normal range at the testing centre
Patients suspected to have organic disease
Patients with cardiac, hepatic, renal, or other serious complications
Patients with psychogenic disease
Patients who are unable to receive pharmacopuncture due to e.g., inflammation or a wound at the relevant acupoints
Other patients whose participation in the trial is judged by a researcher to be problematic

Sites / Locations

Jaseng Hospital of Korean Medicine
Kyung Hee University Hospital at Gangdong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hominis placental pharmacopuncture

Transcutaneous electrical nerve stimulation

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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'.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT04087005

First Posted

September 11, 2019

Last Updated

May 31, 2021

Sponsor

Jaseng Medical Foundation

1. Study Identification

Unique Protocol Identification Number

NCT04087005

Brief Title

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

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

October 17, 2019 (Actual)

Primary Completion Date

July 21, 2020 (Actual)

Study Completion Date

July 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jaseng Medical Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Temporomandibular Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hominis placental pharmacopuncture

Arm Type

Experimental

Arm Description

Arm Title

Transcutaneous electrical nerve stimulation

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

hominis placental pharmacopuncture

Intervention Description

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.

Primary Outcome Measure Information:

Title

The difference in visual analogue scale (VAS) of temporomandibular pain

Description

Time Frame

Week 6

Secondary Outcome Measure Information:

Title

Numeric rating scale (NRS) of TMJ pain and discomfort

Description

Time Frame

Week 6

Title

TMJ range of motion

Description

Time Frame

Week 6

Title

Korean version of Beck's Depression Index-Ⅱ (K-BDI-Ⅱ)

Description

Time Frame

Week 6

Title

Jaw Functional Limitation Scale (JFLS)

Description

Time Frame

Week 6

Title

Patient Global Impression of Change (PGIC)

Description

Time Frame

Week 6

Title

The five level version of EuroQol-5 Dimension (EQ-5D-5L)

Description

Time Frame

Week 6

Title

SF-12

Description

Time Frame

Week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with unilateral or bilateral TMJ pain Patients with VAS≥40mm for the area showing TMJ pain (for patients with bilateral pain, the side with worse pain) Patients complaining of persistent of sporadic TMJ pain for at least 3 months Patients diagnosed as myofascial TMD (Axis I: Group 1) based on the RDC/TMD diagnostic criteria[5] Patients aged 19-70 years on the date they sign the consent form Patients who provide consent to participate in the trial and return the informed consent form Exclusion Criteria: Patients whose current pain episode developed or worsened because of a road traffic accident or traumatic injury Patients diagnosed in Group 2 or 3 of Axis I based on the RDC/TMD diagnostic criteria Patients who have undergone surgery related to the TMJ 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) Patients currently taking steroids, immunosuppressants, psychiatric drugs, or other drugs that could affect the study results 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 Pregnant or breastfeeding women 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 Patients with a history of hypersensitivity after HPP Diabetic patients with uncontrolled blood glucose (fasting blood glucose ≥180mg/dl) Patients with AST (GOT) or ALT (GPT) at least 2 times the normal range at the testing centre Patients with creatinine at least 2 times the normal range at the testing centre Patients suspected to have organic disease Patients with cardiac, hepatic, renal, or other serious complications Patients with psychogenic disease Patients who are unable to receive pharmacopuncture due to e.g., inflammation or a wound at the relevant acupoints Other patients whose participation in the trial is judged by a researcher to be problematic

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

In-Hyuk Ha

Organizational Affiliation

Jaseng Hospital of Korean Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jaseng Hospital of Korean Medicine

City

Seoul

State/Province

Gangnam-Gu

ZIP/Postal Code

135-896

Country

Korea, Republic of

Facility Name

Kyung Hee University Hospital at Gangdong

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32539850

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.

Results Reference

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Efficacy and Safety of JHG002 for Chronic Temporomandibular Joint Dysfunction: A Multicenter Randomized Controlled Trial

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