Clinical trial NCT06778473: Intradermal Acupuncture and Self-rehabilitation Program in Patients With Severe Bell's Palsy
Official title: Effectiveness of Intradermal Acupuncture and Guided Self-rehabilitation Management Program for Severe Bell's Palsy Patients: a Randomized, Placebo-controlled, 2×2 Factorial Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bell Palsy
Keywords: Bell Palsy
Intradermal acupuncture
Self-rehabilitation
Lead sponsor: Zhangjiagang First People's Hospital
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Two by two factorial design
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: The proportion of participants with complete recovery of facial function at the 24-week.
timeFrame: Week 24
Secondary outcomes:
measure: The proportion of participants with complete recovery of facial function.
timeFrame: Week4, Week8, Week12, Week16, Week20
measure: The time to complete recovery of facial function.
timeFrame: Within 24 weeks
measure: The proportion of participants to reach a House-brackmann facial nerve grading system grade of I.
timeFrame: Week4, Week8, Week12, Week16, Week20, Week24
measure: The changes in Sunnybrook Facial Grading System score from baseline.
timeFrame: Week4, Week8, Week12, Week16, Week20, Week24
measure: The changes in Surface Electromyography from baseline.
timeFrame: Week4, Week12, Week24
measure: The changes in Facial Disability Index physical function subscale from baseline.
timeFrame: Week4, Week12, Week24
measure: The changes in Social Appearance Anxiety Scale from baseline.
timeFrame: Week4, Week12, Week24
measure: The changes in Facial Disability Index social/wellbeing function subscale from baseline
timeFrame: Week4, Week12, Week24
measure: The changes in Facial Clinimetric Evaluation Scale from baseline.
timeFrame: Week4, Week12, Week24
measure: The changes in visual analogue scale from baseline.
timeFrame: Week4, Week8
measure: The proportion of participants with synkinesis.
timeFrame: Week 24
measure: The proportion of participants with facial spasm or contracture
timeFrame: Week 24
Other outcomes:
measure: Evaluation of intradermal acupuncture expectation
timeFrame: Baseline
measure: Evaluation of guided self-rehabilitation management program expectation
timeFrame: Baseline
measure: Evaluation of intradermal acupuncture compliance
timeFrame: The 10th day after the onset of palsy until complete recovery or week 24
measure: Evaluation of guided self-rehabilitation management program compliance
timeFrame: The 10th day after the onset of palsy until complete recovery or week 24
measure: Blinding assessment of intradermal acupuncture
timeFrame: Week 24
measure: Blinding assessment of guided self-rehabilitation management program
timeFrame: Week 24
measure: Adverse events assessment
timeFrame: The 10th day after the onset of palsy to week 24
Locations:
city: Suzhou
country: China
facility: Zhangjiagang First People's Hospital
state: Jiangsu
Study officials:
affiliation: Zhangjiagang First People's Hospital
name: yang Jiang, master
role: PRINCIPAL_INVESTIGATOR
References: