Effectiveness of Intradermal Acupuncture and Guided Self-rehabilitation Management Program for Severe Bell's Palsy Patients: a Randomized, Placebo-controlled, 2×2 Factorial Trial
Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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).
Locations
Other Locations
China
Zhangjiagang First People's Hospital
RECRUITING
Suzhou
Contact Information
Primary
yang Jiang, master
17768069362@163.com
17768069362
Backup
Dan Zhang, bachelor
18662237567@163.com
18662237567
Time Frame
Start Date: 2025-03-24
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 552
Treatments
Experimental: 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.
Experimental: 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.
Experimental: 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_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Zhangjiagang First People's Hospital