The Effectiveness and Safety of Integrative Korean Medicine Treatment for Bell's Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Korean integrative medicine.
- Who it may be relevant to
- Registry conditions: Facial Paralysis, Peripheral. Basic parameters: 19 years — 69 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effectiveness and Safety of Integrative Korean Medicine Treatment for Bell's Palsy : A Prospective Observational Preliminary Study
Overview
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.
Interventions
- 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
Primary outcome measures
- Facial disability index [Time frame: week 14]
Secondary outcome measures (7)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
South Korea · 1 center
- Jaseng Hospital of Korean Medicine — Seoul
Identifiers
NCT: NCT04905745 · JS-CT-2021-05