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Acupuncture for Sequelae of Bell's Palsy

Not Applicable
Completed
Conditions
Nervous System Diseases
Facial nerve disorders
Sequelae of Bell's palsy
Registration Number
ISRCTN43104115
Lead Sponsor
Kyung Hee University (South Korea)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
20
Inclusion Criteria

1. Aged between 18-65
2. Diagnosis of Bell's palsy (ICD-10 G51.0), at least 6 months prior to recruitment
3. FDI (Facial Disability Index) score of below 70 in Physical Function, and below 80 in Social/Well-being Function
4. Provided written informed consent

Exclusion Criteria

1. Secondary facial palsy resulting from specific disease such as infection, multiple neuritis, tumour invading the temporal region, cerebral contusion or stroke
2. Patient manifesting Ramsay-Hunt syndrome
3. Bilateral facial palsy
4. Recurred facial palsy
5. Received orally administered corticosteroids or anti-viral agent(aciclovir, valaciclovir, famciclovir, ganciclovir) within 1 month before enrolment
6. Received alternative and complementary modality, i.e. acupuncture, moxibustion, vesicant therapy or massage for treating Bell's palsy within 3 months
7. Received operation, i.e. facial nerve decompression, facial nerve and muscle reconstruction for treating Bell's palsy
8. Suffering serious medical condition such as uncontrolled hypertension, diabetes mellitus requiring insulin injection, past or current malignant tumour, severe dyslipidemia or liver and kidney dysfunction, anaemia, active pulmonary tuberculosis, other infectious disease or systemic diseases insufficient for acupuncture treatment
9. Other neurologic illness
10. Participating in another clinical trial
11. Suffering psychiatric illness insufficient for participation in clinical trial
12. Unable to obtain written consent
13. Pregnant or nursing status, or planning conception during treatment
14. Scar in administration area or systemic illness unsuitable for acupuncture treatment in the judgement of the investigator

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Changes in FDI (Facial Disability Index) after 24 sessions/8 weeks of acupuncture treatment.<br>
Secondary Outcome Measures
NameTimeMethod
Changes in the following, after 24 sessions/8 weeks of acupuncture treatment and one-month follow-up:<br>1. Sunnybrook Facial Grading System<br>2. H-B Scale<br>3. Lip-length and snout indices<br>4. Facial stiffness
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