NCT04087005

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 17, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2020

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

9 months

First QC Date

September 11, 2019

Last Update Submit

May 31, 2021

Conditions

Temporomandibular Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Numeric rating scale (NRS) of TMJ pain and discomfort

    Week 6

  • TMJ range of motion

    Week 6

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

    Week 6

  • Jaw Functional Limitation Scale (JFLS)

    Week 6

  • Patient Global Impression of Change (PGIC)

    Week 6

  • +2 more secondary outcomes

Study Arms (2)

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.

Other: hominis placental pharmacopuncture

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).

Other: hominis placental pharmacopuncture

Interventions

hominis placental pharmacopunctureOTHER

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.

Hominis placental pharmacopunctureTranscutaneous electrical nerve stimulation

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 135-896, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 39895393DERIVED

  • 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.

    PMID: 38779539DERIVED

  • 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.

    PMID: 32539850DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • In-Hyuk Ha

    Jaseng Hospital of Korean Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 11, 2019

First Posted

September 12, 2019

Study Start

October 17, 2019

Primary Completion

July 21, 2020

Study Completion

July 21, 2020

Last Updated

June 2, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)