Acupuncture for Sequelae of Bell's Palsy
- Conditions
- Nervous System DiseasesFacial nerve disordersSequelae 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
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
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
Name Time Method Changes in FDI (Facial Disability Index) after 24 sessions/8 weeks of acupuncture treatment.<br>
- Secondary Outcome Measures
Name Time Method 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