Intradermal Acupuncture and Self-rehabilitation Program in Patients With Severe Bell's Palsy

NCT06778473 · tracked via the Priya Life Science China tracker

Sponsor

Zhangjiagang First People's Hospital

Phase

Not applicable

Started

2025-03-24

Last updated

2025-04-30

Condition(s) studied

Bell Palsy

Investigational drug(s) / intervention(s)

Active Intradermal AcupunctureSham Intradermal AcupunctureGuided self-rehabilitation management programHealth Education

Active 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: 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.

Guided 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.

Health 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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
Zhangjiagang First People's Hospital	Suzhou	Jiangsu	Recruiting

More Zhangjiagang First People's Hospital trials in China

Methylprednisolone for Moderate to Severe Traumatic Brain Injury Recruiting

Other trials for the same condition

Laser Acupuncture for Idiopathic Bell's Palsy Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06778473 on ClinicalTrials.gov ↗ ← All trials in China