Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06732622

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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

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