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

NCT ID: NCT04905745

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-25
• Study Completion Date: 2025-12-31

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.

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Facial palsy

Adulthood facial palsy patients group who receive Korean integrative medicine.

Korean integrative medicine

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jaseng Medical Foundation

OTHER

Sponsor Role: lead

Responsible Party

In-Hyuk Ha, KMD

Director of Jaseng Spine and Joint Research Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

In-Hyuk Ha, KMD,Ph.D

Role: STUDY_DIRECTOR

Jaseng Medical Foundation

Locations

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

In-Hyuk Ha, KMD,Ph.D

Role: CONTACT

hanihata@gmail.com

+82-2-2222-2740

Facility Contacts

Kyoung Sun Park, Dr

Role: primary

lovepks0116@gmail.com

+82-2-2222-2749

Other Identifiers

JS-CT-2021-05

Identifier Type: -

Identifier Source: org_study_id