The Effectiveness and Safety of Integrative Korean Medicine Treatment for Bell's Palsy
1 other identifier
observational
100
1 country
1
Brief Summary
This is an observational study that evaluate the effectiveness and safety of Korean integrative treatments in patients with peripheral facial nerve palsy. Adulthood patients aged between 19 to 69 who were diagnosed with peripheral facial nerve palsy and receive Korean integrative treatments for facial palsy will be enrolled in the study and the change will be followed according to the Facial disability index (FDI) at the 3 month moment after baseline.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 25, 2021
CompletedFirst Submitted
Initial submission to the registry
May 26, 2021
CompletedFirst Posted
Study publicly available on registry
May 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
February 25, 2026
February 1, 2026
6.3 years
May 26, 2021
February 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Facial disability index
This is a questionnaire made to evaluate the subjective sensations of patients on the ability to use facial muscles and their emotional state. It is composed of 10 items, and 1-5 is composed of 5 points per item for movement state, and 6-10 is composed of 6 points per item for sociological state and emotional state.
week 14
Secondary Outcomes (7)
Facial disability index (FDI)
week 1, 5, 14, 53
House-Brackmann facial palsy grade system (HB grade)
week 1, 5, 14, 53 and every week during treatment (for survival analysis in complete recovery)
Numeric rating scale (NRS)
week 1, 5, 14, 53 and every week during treatment
Facial nerve grading system (FNGS 2.0)
week 1, 5, 14, 53
Synkinesis Assessment Questionnaire (SAQ)
week 1, 5, 14, 53
- +2 more secondary outcomes
Study Arms (1)
Facial palsy
Adulthood facial palsy patients group who receive Korean integrative medicine.
Interventions
Any kind of Korean integrative medicine will be applicable and the treatment will be entirely determined by experienced clinicians. On the premise of the above, the following examples are the treatments applicable to the subject of this observational study. * Chuna: Chuna therapy is performed on the face and cervical spine to induce decompression of the captured facial nerve. In addition, SJS Non-Resistance Technique-Facial palsy (SJS NRT-F), a technique of Chuna, can be performed to stimulate the intrinsic receptive sensation of the facial muscles to promote the neuromuscular response. * Acupuncture: acupuncture can be applied on paralyzed muscle and others to improve symptoms and paralysis status. * Pharmacopuncture: pharmacopuncture can be applied on paralyzed muscle and others to improve symptoms and paralysis status. * Herbal medicine: It is prescribed according to clinical judgment according to the patient's symptoms and disease status.
Eligibility Criteria
adulthood male and female patients with peripheral facial nerve palsy
You may qualify if:
- age of 19 to 69
- diagnosed with unilateral peripheral facial nerve palsy
- onset of facial palsy within 3 weeks or less.
- an individual who can provide written consent form to participate in the study.
You may not qualify if:
- diagnosed with central nervous system disease causing facial palsy
- secondary facial palsy after multiple sclerosis, tumor, cerebrovascular disease and temporal bone fracture.
- Ramsay-Hunt syndrome
- bilateral or recurrent facial nerve palsy.
- an individual who received any treatment that can have a significant effect on changes in facial paralysis within recent 2 month. (ie. facial nerve decompression surgery)
- already or planned to be pregnant or breast-feeding within the study period.
- uncontrolled diabetes mellitus within the last 3 months.
- within a month after participating any other facial palsy-related clinical trials, or planning to participate other clinical trials within 6 month.
- impossible to read and understand the documents, regarding informed consent form and the questionnaires.
- difficult to participate according to the judgement of researchers.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
In-Hyuk Ha, KMD,Ph.D
Jaseng Medical Foundation
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Jaseng Spine and Joint Research Institute
Study Record Dates
First Submitted
May 26, 2021
First Posted
May 28, 2021
Study Start
May 25, 2021
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
February 25, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share