Facial Paralysis, PeripheralNCT04905745
The Effectiveness and Safety of Integrative Korean Medicine Treatment for Bell's Palsy
An observational study of Facial Paralysis, Peripheral, run by Jaseng Medical Foundation at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Facial Paralysis, Peripheral
- What is being tested?
- Korean integrative medicine
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 May 2021to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adulthood male and female patients with peripheral facial nerve palsy
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896
Kyoung Sun Park, Dr, +82-2-2222-2749, lovepks0116@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Facial Paralysis, Peripheral
- Being tested
- Korean integrative medicine
- Medical subject headings
- Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Korean integrative medicineProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Facial palsy | Adulthood facial palsy patients group who receive Korean integrative medicine. Receives: Procedure: Korean integrative medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 14
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 1, 5, 14, 53
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start25 May 2021
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Paralysis, PeripheralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Hyuk Ha, KMD, Jaseng Medical Foundation
- Investigators
- In-Hyuk Ha, KMD,Ph.D, Study director, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905745
- Sponsor's protocol ID
- JS-CT-2021-05
- Status last verified
- Feb 2026
- First submitted
- 26 May 2021
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Integrative Korean Medicine Treatment for Bell's Palsy : A Prospective Observational Preliminary Study
- ClinicalTrials.gov ID
- NCT04905745
- Acronym / sponsor ID
- JS-CT-2021-05
- Conditions
- Facial Paralysis, Peripheral
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Facial palsy | – | Procedure: Korean integrative medicineAdulthood facial palsy patients group who receive Korean integrative medicine. |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adulthood male and female patients with peripheral facial nerve palsy
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Korean integrative medicineAny 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. | Procedure or surgery | Facial palsy |
Primary outcome
Facial disability index
Time frame: week 14
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.
7 secondary outcomes
Facial disability index (FDI)
Time frame: week 1, 5, 14, 53
House-Brackmann facial palsy grade system (HB grade)
Time frame: week 1, 5, 14, 53 and every week during treatment (for survival analysis in complete recovery)
Numeric rating scale (NRS)
Time frame: week 1, 5, 14, 53 and every week during treatment
Facial nerve grading system (FNGS 2.0)
Time frame: week 1, 5, 14, 53
Synkinesis Assessment Questionnaire (SAQ)
Time frame: week 1, 5, 14, 53
Patient Global Impression of Change (PGIC)
Time frame: week 5, 14, 53
Short Form-12 Health Survey (SF-12)
Time frame: week 1, 5, 14, 53
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
In-Hyuk Ha, KMD,Ph.D study director
Jaseng Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Facial Paralysis, Peripheral, run by Jaseng Medical Foundation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact In-Hyuk Ha, KMD,Ph.D (+82-2-2222-2740, hanihata@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial disability index (time frame: week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.