Effectiveness of Intradermal Acupuncture and Guided Self-rehabilitation Management Program for Severe Bell's Palsy Patients: a Randomized, Placebo-controlled, 2×2 Factorial Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 552
- 试验地点
- 1
- 主要终点
- The proportion of participants with complete recovery of facial function at the 24-week.
研究概览
简要总结
This study aims to assess the effect of intradermal acupuncture(IA) and guided self-rehabilitation management program(GRMP) (either single or combined) for patients with severe Bell's Palsy.
详细描述
After confirming the details of the trial process and signing an informed consent, all participants will be randomly divided into the following four groups: Active IA+GRMP, Active IA+ HE, sham IA+ GRMP, sham IA + HE. They will receive active or sham IA and GRMP or HE until complete recovery or completion of follow up (a duration of 24 weeks).Follow-ups will be done in 4-week, 8-week, 12-week,16-week, 20-week, and 24-week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Bell's palsy according to "Clinical Practice Guideline: Bell's Palsy" published by AAO-HNS in 2013;
- •First onset of Bell's palsy with only one side affected;
- •On the 10th day after the onset of palsy, HBGS score ranging from grade IV to VI;
- •According to the latest Chinese Guidelines for Bell's Palsy, within 72 hours of symptom onset for Bell's Palsy, oraling prednisolone 30mg qd for 5 days, followed by tapering to zero in decrements of 5 mg per day;
- •Adults aged 18 years of age or older (no limitation on gender).
排除标准
- •Facial paralysis caused by acoustic neuroma, otitis media, mastoiditis, mumps, Hunter's syndrome, cranial base meningitis, intracranial metastasis of cancer or multiple sclerosis;
- •Fear of intradermal acupuncture;
- •allergy to adhesive tape;
- •Severe allergic diseases, significant skin lesions, tumors, and severe or unstable internal diseases involving the cardiovascular, respiratory, endocrine, digestive, or hematological system;
- •Cognitive impairment, mental illness, contagious disease, pregnant and lactating;
- •Previously treated withintradermal acupuncture or participating in other clinical trial within 3 months.
研究组 & 干预措施
"Active intradermal acupuncture" plus "Guided self-rehabilitation management program"
Active IA will be retained in the acupoints for 72h before being removed, then rested for one day.Participants receive Active IA until full recovery or completion of follow up (a duration of 24 weeks).
Participants will be taught and corrected self-rehabilitation techniques by Physical Medicine and Rehabilitation(PMR) therapists at regular outpatient clinic visit (twice weekly for the first 12 weeks, then weekly until full recovery or follow-up completed) and practice at-home therapy and diarize accomplished exercises.
干预措施: Active Intradermal Acupuncture (Device)
"Active intradermal acupuncture" plus "Guided self-rehabilitation management program"
Active IA will be retained in the acupoints for 72h before being removed, then rested for one day.Participants receive Active IA until full recovery or completion of follow up (a duration of 24 weeks).
Participants will be taught and corrected self-rehabilitation techniques by Physical Medicine and Rehabilitation(PMR) therapists at regular outpatient clinic visit (twice weekly for the first 12 weeks, then weekly until full recovery or follow-up completed) and practice at-home therapy and diarize accomplished exercises.
干预措施: Guided self-rehabilitation management program (Other)
"Active intradermal acupuncture" plus "Health education"
Active IA will be retained in the acupoints for 72h before being removed, then rested for one day.Participants receive Active IA until full recovery or completion of follow up (a duration of 24 weeks).
Participants will be taught health education content about the disease by PMR therapists at regular outpatient clinic visit (twice weekly for the first 12 weeks, then weekly until full recovery or follow-up completed) and have no homework and keep no daily logs.
干预措施: Active Intradermal Acupuncture (Device)
"Active intradermal acupuncture" plus "Health education"
Active IA will be retained in the acupoints for 72h before being removed, then rested for one day.Participants receive Active IA until full recovery or completion of follow up (a duration of 24 weeks).
Participants will be taught health education content about the disease by PMR therapists at regular outpatient clinic visit (twice weekly for the first 12 weeks, then weekly until full recovery or follow-up completed) and have no homework and keep no daily logs.
干预措施: Health Education (Other)
"Sham intradermal acupuncture" plus "Guided self-rehabilitation management program"
Sham IA will be retained in the acupoints for 72h before being removed, then rested for one day.Participants receive Sham IA until full recovery or completion of follow up (a duration of 24 weeks).
Participants will be taught and corrected self-rehabilitation techniques by PMR therapists at regular outpatient clinic visit (twice weekly for the first 12 weeks, then weekly until full recovery or follow-up completed) and practice at-home therapy and diarize accomplished exercises.
干预措施: Sham Intradermal Acupuncture (Device)
"Sham intradermal acupuncture" plus "Guided self-rehabilitation management program"
Sham IA will be retained in the acupoints for 72h before being removed, then rested for one day.Participants receive Sham IA until full recovery or completion of follow up (a duration of 24 weeks).
Participants will be taught and corrected self-rehabilitation techniques by PMR therapists at regular outpatient clinic visit (twice weekly for the first 12 weeks, then weekly until full recovery or follow-up completed) and practice at-home therapy and diarize accomplished exercises.
干预措施: Guided self-rehabilitation management program (Other)
"Sham intradermal acupuncture" plus "Health education"
Sham IA will be retained in the acupoints for 72h before being removed, then rested for one day.Participants receive Sham IA until full recovery or completion of follow up (a duration of 24 weeks).
Participants will be taught health education content about the disease by PMR therapists at regular outpatient clinic visit (twice weekly for the first 12 weeks, then weekly until full recovery or follow-up completed) and have no homework and keep no daily logs.
干预措施: Sham Intradermal Acupuncture (Device)
"Sham intradermal acupuncture" plus "Health education"
Sham IA will be retained in the acupoints for 72h before being removed, then rested for one day.Participants receive Sham IA until full recovery or completion of follow up (a duration of 24 weeks).
Participants will be taught health education content about the disease by PMR therapists at regular outpatient clinic visit (twice weekly for the first 12 weeks, then weekly until full recovery or follow-up completed) and have no homework and keep no daily logs.
干预措施: Health Education (Other)
结局指标
主要结局
The proportion of participants with complete recovery of facial function at the 24-week.
时间窗: Week 24
The complete recovery of facial function was defined as Sunnybrook Facial Grading System score of 100 points.
次要结局
- The proportion of participants with complete recovery of facial function.(Week4, Week8, Week12, Week16, Week20)
- The time to complete recovery of facial function.(Within 24 weeks)
- The proportion of participants to reach a House-brackmann facial nerve grading system grade of I.(Week4, Week8, Week12, Week16, Week20, Week24)
- The changes in Sunnybrook Facial Grading System score from baseline.(Week4, Week8, Week12, Week16, Week20, Week24)
- The changes in Surface Electromyography from baseline.(Week4, Week12, Week24)
- The changes in Facial Disability Index physical function subscale from baseline.(Week4, Week12, Week24)
- The changes in Social Appearance Anxiety Scale from baseline.(Week4, Week12, Week24)
- The changes in Facial Disability Index social/wellbeing function subscale from baseline(Week4, Week12, Week24)
- The changes in Facial Clinimetric Evaluation Scale from baseline.(Week4, Week12, Week24)
- The changes in visual analogue scale from baseline.(Week4, Week8)
- The proportion of participants with synkinesis.(Week 24)
- The proportion of participants with facial spasm or contracture(Week 24)
研究者
Yang Jiang
Principal Investigator
Zhangjiagang First People's Hospital