Intradermal Acupuncture and Self-rehabilitation Program in Patients With Severe Bell's Palsy
NCT ID: NCT06778473
Last Updated: 2025-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
552 participants
INTERVENTIONAL
2025-03-24
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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"Active intradermal acupuncture" plus "Guided self-rehabilitation management program"
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.
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.
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.
"Active intradermal acupuncture" plus "Health education"
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.
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.
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
"Sham intradermal acupuncture" plus "Guided self-rehabilitation management program"
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.
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.
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.
"Sham intradermal acupuncture" plus "Health education"
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.
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.
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
Interventions
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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.
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.
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.
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Zhangjiagang First People's Hospital
OTHER
Responsible Party
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Yang Jiang
Principal Investigator
Principal Investigators
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yang Jiang, master
Role: PRINCIPAL_INVESTIGATOR
Zhangjiagang First People's Hospital
Locations
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Zhangjiagang First People's Hospital
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LSD2022020
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ZJGQNKJ202231
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ZJGYYLL202407030
Identifier Type: -
Identifier Source: org_study_id
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