RecruitingNot ApplicableNCT06778473

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

Effectiveness of Intradermal Acupuncture and Guided Self-rehabilitation Management Program for Severe Bell's Palsy Patients: a Randomized, Placebo-controlled, 2×2 Factorial Trial

Sponsor

Zhangjiagang First People's Hospital

Enrollment

552 participants

Start Date

Mar 24, 2025

Study Type

INTERVENTIONAL

Conditions

Bell Palsy

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria6

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.

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Interventions

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.

DEVICESham 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.

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.

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