Clinical trial NCT04905745: The Effectiveness and Safety of Integrative Korean Medicine Treatment for Bell's Palsy
Official title: The Effectiveness and Safety of Integrative Korean Medicine Treatment for Bell's Palsy : A Prospective Observational Preliminary Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Facial Paralysis, Peripheral
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adulthood male and female patients with peripheral facial nerve palsy

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.

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.

Primary outcomes:
measure: Facial disability index
timeFrame: week 14
Secondary outcomes:
measure: Facial disability index (FDI)
timeFrame: week 1, 5, 14, 53
measure: House-Brackmann facial palsy grade system (HB grade)
timeFrame: week 1, 5, 14, 53 and every week during treatment (for survival analysis in complete recovery)
measure: Numeric rating scale (NRS)
timeFrame: week 1, 5, 14, 53 and every week during treatment
measure: Facial nerve grading system (FNGS 2.0)
timeFrame: week 1, 5, 14, 53
measure: Synkinesis Assessment Questionnaire (SAQ)
timeFrame: week 1, 5, 14, 53
measure: Patient Global Impression of Change (PGIC)
timeFrame: week 5, 14, 53
measure: Short Form-12 Health Survey (SF-12)
timeFrame: week 1, 5, 14, 53
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
state: Gangnam-Gu
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha, KMD,Ph.D
role: STUDY_DIRECTOR
References: