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.
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;
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;
Factorial
Active Intradermal Acupuncture
DeviceDepending on acupoints' location, φ0.20\*1.5mm or φ0.20\*1.2mm AIA will be selected. Insert the Active IA vertically into the acupoint and retain it in the skin. Active IA will be retained for 72 hours with a day's rest after removal. During the period of needle retention, participants will be required to press the Active IA 4 times a day for approximately 1 minute each time, with as much stimulation as the patient can tolerate, at intervals of approximately 4 hours.
Sham Intradermal Acupuncture
DeviceSham intradermal acupuncture will be attached to the acupoints and retained for 72 hours with a day's rest after removal. During the period of sham needle retention,pressing times and frequencies are identical to those in the active intradermal acupuncture group.
Guided self-rehabilitation management program
Other interventionSelf-rehabilitation techniques are taught in individual sessions of about 40 minutes at each outpatient clinic visit, as detailed below: Analysis of the problem, Education, Massage, Facial muscles exercise,Synkinesis or spasticity management, Homework. Participants are requested to perform daily facial muscle exercises as prescribed by the therapist and keep the written diary on a daily basis. The therapists retrieve and evaluate the diaries at each visit.
Health Education
Other interventionHealth education knowledge about the disease such as etiology, pathology,clinical symptoms of Bell's palsy, Bell's palsy diagnosis and role of medical tests;medication education;complications and sequelae,etc
The proportion of participants with complete recovery of facial function at the 24-week.
The complete recovery of facial function was defined as Sunnybrook Facial Grading System score of 100 points.
The proportion of participants with complete recovery of facial function.
The complete recovery of facial function was defined as Sunnybrook Facial Grading System score of 100 points.
The time to complete recovery of facial function.
The complete recovery of facial function was defined as Sunnybrook Facial Grading System score of 100 points.The recovery time is defined as the time from onset of Bell's palsy until complete recovery of facial function.
The proportion of participants to reach a House-brackmann facial nerve grading system grade of I.
House-Brackmann facial nerve grading system provides a simple comprehensive evaluation of the resting and moving states of facial muscles, involving a six-point scale with I being normal and VI total, flaccid paralysis.
The changes in Sunnybrook Facial Grading System score from baseline.
SFGS is based on the evaluation of resting symmetry , degree of voluntary excursion of facial muscles, and degree of synkinesis associated with specified voluntary movement. Possible scores range from 0(total paralysis) to 100(normal).
Evaluation of intradermal acupuncture expectation
A brief 4-item Acupuncture Expectancy Scale score ranged from 4 to 20, with higher scores indicating greater expectancy.
Evaluation of guided self-rehabilitation management program expectation
Participants will be asked to answer the following question: "Do you think GRMP is helpful for Bell's palsy?"
Evaluation of intradermal acupuncture compliance
Compliance Rate=(actual treatment times/total treatment times) \*100%.
Evaluation of guided self-rehabilitation management program compliance
Compliance Rate=(actual session times/total session times) \*100%. For GRMP homework, we measure and quantify participants' adherence by the daily diary.
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