The Effectiveness and Safety of Integrative Korean Medicine Treatment for Bell's Palsy

The Effectiveness and Safety of Integrative Korean Medicine Treatment for Bell's Palsy : A Prospective Observational Preliminary Study

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.

Study Overview

• Status: Recruiting
• Conditions: Facial Paralysis, Peripheral
• Intervention / Treatment: Procedure: Korean integrative medicine

Detailed Description

This is an observational study that evaluate the effectiveness and safety of Korean integrative treatments in patients with peripheral facial nerve palsy. A total of 100 patients who are in age of from 19 to 69, diagnosed with peripheral facial nerve palsy, in acute to subacute stage, and who receive Korean integrative treatments for facial palsy will be enrolled in this study. This study is an observational study and the intervention will be decided not by researchers, but by physicians in the real clinical practice. The treatment will be entirely determined according to each subject's medical conditions by an experienced clinician who has received more than 6 years of education and more than 3 years of training. This study will only record the contents of the intervention. Among all the data generated during the study period, data deemed necessary can be collected in the case record forms. The intervention will also be determined by the clinician, and the researcher presented assessment and data collection timepoints, which is independent of the treatment schedule. The on-treatment visit schedule will be once a week during the treatment is ongoing, and follow-up visit schedule will be on the 5th, 14th, and 53rd weeks after the baseline.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: In-Hyuk Ha, KMD,Ph.D; Phone Number: +82-2-2222-2740; Email: hanihata@gmail.com

Study Locations

• South Korea
  • Gangnam-Gu
    • Seoul, Gangnam-Gu, South Korea, 135-896
      • Recruiting
      • Jaseng Hospital of Korean Medicine
      • Contact: Kyoung Sun Park, Dr; Phone Number: +82-2-2222-2749; Email: lovepks0116@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

adulthood male and female patients with peripheral facial nerve palsy

Description

Inclusion Criteria:

1. age of 19 to 69
2. diagnosed with unilateral peripheral facial nerve palsy
3. onset of facial palsy within 3 weeks or less.
4. an individual who can provide written consent form to participate in the study.

Exclusion Criteria:

1. diagnosed with central nervous system disease causing facial palsy
2. secondary facial palsy after multiple sclerosis, tumor, cerebrovascular disease and temporal bone fracture.
3. Ramsay-Hunt syndrome
4. bilateral or recurrent facial nerve palsy.
5. 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)
6. already or planned to be pregnant or breast-feeding within the study period.
7. uncontrolled diabetes mellitus within the last 3 months.
8. within a month after participating any other facial palsy-related clinical trials, or planning to participate other clinical trials within 6 month.
9. impossible to read and understand the documents, regarding informed consent form and the questionnaires.
10. difficult to participate according to the judgement of researchers.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Facial palsy; Adulthood facial palsy patients group who receive Korean integrative medicine.

Procedure: Korean integrative medicine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facial disability index (FDI)	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 1, 5, 14, 53
House-Brackmann facial palsy grade system (HB grade)	HB grade is a scale to evaluate facial palsy into 6 stages based on the severity of facial palsy, especially the muscles around the mouth and the muscles arount the eyes.	week 1, 5, 14, 53 and every week during treatment (for survival analysis in complete recovery)
Numeric rating scale (NRS)	NRS is a 11-point scale of 0-10. the researcher will rate NRS for postauricular pain and discomforts in the face and cervical area.	week 1, 5, 14, 53 and every week during treatment
Facial nerve grading system (FNGS 2.0)	FNGS 2.0 is calculated based on the total score by section by section in facial part and additional score with synkinesis movement. The result of FNGS 2.0 well indicate the palsy status, with the grade of 1-6 and 4-24 points.	week 1, 5, 14, 53
Synkinesis Assessment Questionnaire (SAQ)	The SAQ is a questionnaire that calculates the total score of 9 representative symptoms of synkinesis into 1-5 points for each item.	week 1, 5, 14, 53
Patient Global Impression of Change (PGIC)	Patient global impression of change (PGIC) is a method that allows the patient to subjectively evaluate the degree of improvement in 7 degree of scale.	week 5, 14, 53
Short Form-12 Health Survey (SF-12)	The SF-12 is a questionnaire that evaluates the overall health-related quality of lives (HRQoL). SF-12 consists of 12 questions covering following 8 areas, to evaluate functional health and well-being of individuals both ill and healthy; physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health.	week 1, 5, 14, 53

Collaborators and Investigators

• Sponsor: Jaseng Medical Foundation
• Investigators: Study Director: In-Hyuk Ha, KMD,Ph.D, Jaseng Medical Foundation

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2021
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Facial Paralysis
• Other Study ID Numbers: JS-CT-2021-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No