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
3 other identifiers
interventional
552
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2025
CompletedFirst Posted
Study publicly available on registry
January 16, 2025
CompletedStudy Start
First participant enrolled
March 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
April 30, 2025
April 1, 2025
4.5 years
January 12, 2025
April 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The 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.
Week 24
Secondary Outcomes (12)
The proportion of participants with complete recovery of facial function.
Week4, Week8, Week12, Week16, Week20
The time to complete recovery of facial function.
Within 24 weeks
The proportion of participants to reach a House-brackmann facial nerve grading system grade of I.
Week4, Week8, Week12, Week16, Week20, Week24
The changes in Sunnybrook Facial Grading System score from baseline.
Week4, Week8, Week12, Week16, Week20, Week24
The changes in Surface Electromyography from baseline.
Week4, Week12, Week24
- +7 more secondary outcomes
Other Outcomes (7)
Evaluation of intradermal acupuncture expectation
Baseline
Evaluation of guided self-rehabilitation management program expectation
Baseline
Evaluation of intradermal acupuncture compliance
The 10th day after the onset of palsy until complete recovery or week 24
- +4 more other outcomes
Study Arms (4)
"Active intradermal acupuncture" plus "Guided self-rehabilitation management program"
EXPERIMENTALActive IA will be retained in the acupoints for 72h before being removed, then rested for one day.Participants receive Active IA until full recovery or completion of follow up (a duration of 24 weeks). Participants will be taught and corrected self-rehabilitation techniques by Physical Medicine and Rehabilitation(PMR) therapists at regular outpatient clinic visit (twice weekly for the first 12 weeks, then weekly until full recovery or follow-up completed) and practice at-home therapy and diarize accomplished exercises.
"Active intradermal acupuncture" plus "Health education"
EXPERIMENTALActive IA will be retained in the acupoints for 72h before being removed, then rested for one day.Participants receive Active IA until full recovery or completion of follow up (a duration of 24 weeks). Participants will be taught health education content about the disease by PMR therapists at regular outpatient clinic visit (twice weekly for the first 12 weeks, then weekly until full recovery or follow-up completed) and have no homework and keep no daily logs.
"Sham intradermal acupuncture" plus "Guided self-rehabilitation management program"
EXPERIMENTALSham IA will be retained in the acupoints for 72h before being removed, then rested for one day.Participants receive Sham IA until full recovery or completion of follow up (a duration of 24 weeks). Participants will be taught and corrected self-rehabilitation techniques by PMR therapists at regular outpatient clinic visit (twice weekly for the first 12 weeks, then weekly until full recovery or follow-up completed) and practice at-home therapy and diarize accomplished exercises.
"Sham intradermal acupuncture" plus "Health education"
SHAM COMPARATORSham IA will be retained in the acupoints for 72h before being removed, then rested for one day.Participants receive Sham IA until full recovery or completion of follow up (a duration of 24 weeks). Participants will be taught health education content about the disease by PMR therapists at regular outpatient clinic visit (twice weekly for the first 12 weeks, then weekly until full recovery or follow-up completed) and have no homework and keep no daily logs.
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhangjiagang First People's Hospital
Suzhou, Jiangsu, 215600, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
yang Jiang, master
Zhangjiagang First People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 12, 2025
First Posted
January 16, 2025
Study Start
March 24, 2025
Primary Completion (Estimated)
September 30, 2029
Study Completion (Estimated)
December 31, 2029
Last Updated
April 30, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share