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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
552
Depending 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 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.
Zhangjiagang First People's Hospital
Suzhou, Jiangsu, China
RECRUITINGThe 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.
Time frame: Week 24
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.
Time frame: Week4, Week8, Week12, Week16, Week20
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.
Time frame: Within 24 weeks
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.
Time frame: Week4, Week8, Week12, Week16, Week20, Week24
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).
Time frame: Week4, Week8, Week12, Week16, Week20, Week24
The changes in Surface Electromyography from baseline.
The main analytical indicator of sEMG used currently in Bell's palsy detection is the root mean square (RMS)value,quantified as the ratio of the infected side to the unaffected side (%).The higher the ratio, the better the facial nerve function recovery.
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Self-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 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
Time frame: Week4, Week12, Week24
The changes in Facial Disability Index physical function subscale from baseline.
Facial Disability Index(FDI) is a disease-specific, self-report instrument designed to evaluate the degree of disability in patients with facial nerve disorders.FDI includes 2 subscales: the FDI- physical function subscale and the FDI-social/ wellbeing function subscale.Possible scores of every subscale range from 0(worst) to 100(best).
Time frame: Week4, Week12, Week24
The changes in Social Appearance Anxiety Scale from baseline.
The SAAS is a psychometrically validated measure of social anxiety about one's appearance.Possible scores range from 16 to 80, with higher scores indicating higher degree of social appearance anxiety.
Time frame: Week4, Week12, Week24
The changes in Facial Disability Index social/wellbeing function subscale from baseline
Facial Disability Index(FDI) is a disease-specific, self-report instrument designed to evaluate the degree of disability in patients with facial nerve disorders.FDI includes 2 subscales: the FDI- physical function subscale and the FDI-social/ wellbeing function subscale.Possible scores of every subscale range from 0(worst) to 100(best).
Time frame: Week4, Week12, Week24
The changes in Facial Clinimetric Evaluation Scale from baseline.
The FACE questionnaire is a validated instrument that is used to assess quality of life related to peripheral facial palsy. Possible scores range from 0(worst) to 100(best)
Time frame: Week4, Week12, Week24
The changes in visual analogue scale from baseline.
Pain around the ear, in the face, or in the neck is assessed using VAS that ranged from 0 to 10 points, where 0 was no pain and 10 very severe pain.
Time frame: Week4, Week8
The proportion of participants with synkinesis.
Time frame: Week 24
The proportion of participants with facial spasm or contracture
Time frame: Week 24