The Effectiveness and Safety of Integrative Korean Medicine Treatment for Bell's Palsy : A Prospective Observational Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Facial disability index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Facial palsy
Adulthood facial palsy patients group who receive Korean integrative medicine.
干预措施: Korean integrative medicine (Procedure)
结局指标
主要结局
Facial disability index
时间窗: 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.
次要结局
- Facial nerve grading system (FNGS 2.0)(week 1, 5, 14, 53)
- Short Form-12 Health Survey (SF-12)(week 1, 5, 14, 53)
- Patient Global Impression of Change (PGIC)(week 5, 14, 53)
- Facial disability index (FDI)(week 1, 5, 14, 53)
- Synkinesis Assessment Questionnaire (SAQ)(week 1, 5, 14, 53)
- House-Brackmann facial palsy grade system (HB grade)(week 1, 5, 14, 53 and every week during treatment (for survival analysis in complete recovery))
- Numeric rating scale (NRS)(week 1, 5, 14, 53 and every week during treatment)
研究者
In-Hyuk Ha, KMD
Director of Jaseng Spine and Joint Research Institute
Jaseng Medical Foundation