Actively Recruiting
Laser Acupuncture for Idiopathic Bell's Palsy: a Randomized Controlled Trial
Led by Beijing Tongren Hospital · Updated on 2024-12-13
360
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Bell's palsy is a condition marked by sudden one-sided facial weakness that affects appearance and daily life, impacting social, work, and emotional well-being. Researchers are evaluating whether laser acupuncture can reduce symptoms in people diagnosed with idiopathic Bell's palsy who have moderate to severe facial paralysis, classified as House-Brackmann grade 3 or higher. The trial randomly assigned 360 patients into three groups: one received laser acupuncture plus oral prednisolone, another received sham laser acupuncture plus prednisolone, and the third was a control group receiving only prednisolone. The laser acupuncture groups underwent 12 sessions over 4 weeks, three times per week, using a special laser device targeting specific facial and body acupuncture points. Prednisolone was given orally over 12 days in a tapering dose. Participants are assessed using several facial function scales including the House-Brackmann grading system, Sunnybrook facial grading scale, Facial Disability Index, and Facial Clinimetric Evaluation Scale. These evaluations occur at the start and at 2, 4, 6, 8, 12, and 24 weeks to monitor changes. The study aims to measure improvement in facial movement and disability over time while monitoring safety and treatment effects throughout the 24-week follow-up period.
CONDITIONS
Brief Title
Laser Acupuncture for Idiopathic Bell's Palsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with idiopathic Bell's Palsy
- House-Brackmann grade 3 or higher facial paralysis
- Age between 18 and 65 years
You will not qualify if you...
- Serious mental illness, neurological disorders, or systemic diseases like malignant tumors
- Planning pregnancy, currently pregnant, or breastfeeding
- Bell's Palsy lasting more than 8 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive 12 days of oral Prednisolone and, depending on their group, 4 weeks of laser acupuncture or sham laser acupuncture treatment.
3 visits per week for laser or sham laser acupuncture treatments
Duration - Up to 20 weeks after treatment
Participants are monitored for clinical outcomes and recovery after treatment ends.
Visits at weeks 6, 8, 12, and 24 after baseline
Trial Site Locations
Total: 1 location
1
China Beijing TongRen Hospital, Capital Medical University Beijing, China
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
D
Dong Wu, Doctor
H
Haihong Lian, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here