Bell Palsy
Conditions
Keywords
Bell Palsy, Intradermal acupuncture, Self-rehabilitation
Brief summary
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.
Detailed description
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.
Interventions
OTHERHealth Education
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
DEVICEActive Intradermal Acupuncture
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.
OTHERGuided self-rehabilitation management program
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.
Sponsors
Zhangjiagang First People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Two by two factorial design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of participants with complete recovery of facial function at the 24-week. | Week 24 | The complete recovery of facial function was defined as Sunnybrook Facial Grading System score of 100 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The changes in Sunnybrook Facial Grading System score from baseline. | Week4, Week8, Week12, Week16, Week20, Week24 | 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). |
| The changes in Facial Disability Index physical function subscale from baseline. | Week4, Week12, Week24 | 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). |
| The changes in Social Appearance Anxiety Scale from baseline. | Week4, Week12, Week24 | 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. |
| The changes in Facial Disability Index social/wellbeing function subscale from baseline | Week4, Week12, Week24 | 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). |
| The changes in Facial Clinimetric Evaluation Scale from baseline. | Week4, Week12, Week24 | 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) |
| The changes in visual analogue scale from baseline. | Week4, Week8 | 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. |
| The proportion of participants with synkinesis. | Week 24 | — |
| The proportion of participants with facial spasm or contracture | Week 24 | — |
| The proportion of participants with complete recovery of facial function. | Week4, Week8, Week12, Week16, Week20 | 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. | Within 24 weeks | 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. | Week4, Week8, Week12, Week16, Week20, Week24 | 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 Surface Electromyography from baseline. | Week4, Week12, Week24 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of intradermal acupuncture compliance | The 10th day after the onset of palsy until complete recovery or week 24 | Compliance Rate=(actual treatment times/total treatment times) \*100%. |
| Evaluation of guided self-rehabilitation management program compliance | The 10th day after the onset of palsy until complete recovery or week 24 | Compliance Rate=(actual session times/total session times) \*100%. For GRMP homework, we measure and quantify participants' adherence by the daily diary. |
| Blinding assessment of intradermal acupuncture | Week 24 | Participants will be asked the following question: do you think you have received active intradermal acupuncture in the past weeks? |
| Blinding assessment of guided self-rehabilitation management program | Week 24 | Participants will be asked the following question: do you think you have received guided self-rehabilitation management program in the past weeks? |
| Adverse events assessment | The 10th day after the onset of palsy to week 24 | Adverse events and severe adverse events will be recorded in the case report form, whether related to interventions or not. |
| Evaluation of guided self-rehabilitation management program expectation | Baseline | Participants will be asked to answer the following question: Do you think GRMP is helpful for Bell's palsy? |
| Evaluation of intradermal acupuncture expectation | Baseline | A brief 4-item Acupuncture Expectancy Scale score ranged from 4 to 20, with higher scores indicating greater expectancy. |
Countries
China
Contacts
Primary Contactyang Jiang, master
Backup ContactDan Zhang, bachelor
Outcome results
None listed