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

Zhangjiagang First People's Hospital

Status: Enrolling

Conditions: Bell Palsy

Treatments: Device: Active Intradermal Acupuncture; Other: Health Education; Other: Guided self-rehabilitation management program; Device: Sham Intradermal Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06778473

ZJGYYLL202407030

LSD2022020 (Other Grant/Funding Number)

ZJGQNKJ202231 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 552 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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552 participants in 4 patient groups

"Active intradermal acupuncture" plus "Guided self-rehabilitation management program"

Experimental group

Description:

Active 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.

Treatment:

Other: Guided self-rehabilitation management program

Device: Active Intradermal Acupuncture

"Active intradermal acupuncture" plus "Health education"

Experimental group

Description:

Active 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.

Treatment:

Other: Health Education

Device: Active Intradermal Acupuncture

"Sham intradermal acupuncture" plus "Guided self-rehabilitation management program"

Experimental group

Description:

Sham 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.

Treatment:

Device: Sham Intradermal Acupuncture

Other: Guided self-rehabilitation management program

"Sham intradermal acupuncture" plus "Health education"

Sham Comparator group

Description:

Sham 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.

Treatment:

Device: Sham Intradermal Acupuncture

Other: Health Education