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

NCT06778473 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 552

Last updated 2025-04-30

No results posted yet for this 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.

Conditions

  • Bell Palsy

Interventions

DEVICE

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.

DEVICE

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.

OTHER

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.

OTHER

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

Sponsors & Collaborators

  • Zhangjiagang First People's Hospital

    lead OTHER

Principal Investigators

  • yang Jiang, master · Zhangjiagang First People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-24
Primary Completion
2029-09-30
Completion
2029-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06778473 on ClinicalTrials.gov