Clinical efficacy and safety of thread-embedding acupuncture for treatment of the sequelae of Bell’s palsy
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0002557
- Lead Sponsor
- Kyung Hee University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 56
1. Male or female aged 18 - 65 years
2. A diagnosis of Bell’s palsy made =3 months prior to screening
3. Facial Disability Index (FDI) <80 on the social aspect and <70 on the physical aspect
4. Ability to communicate adequately with the researcher and respond to the questionnaire in writing
5. Willingness to sign a form stating that they will not receive any treatment other than the prescribed treatment within the treatment period
6. Willingness to participate in the study after providing written informed consent
1. A history of receiving any other treatment that may affect the study outcomes for 2 months prior to the screening (oral administration of steroids or antiviral drugs, surgical history for treatment of facial palsy such as facial nerve compression, or facial thread-embedding therapy)
2. History of hypersensitivity to TEA or severe keloid
3. Ramsay-Hunt Syndrome
4. Bilateral facial nerve palsy or recurrent facial nerve palsy (more than two occurrences)
5. Secondary facial nerve palsy from multiple neuritis, tumor invading the temporal bone, trauma, brain contusion, or stroke
6. Chronic otitis media, temporomandibular fracture, or history of ear surgery
7. Inappropriate condition for TEA administration due to skin disease or hemostatic disorder (prothrombin time international normalized ratio [PT INR] >2.0 or taking anticoagulant)
8. Liver function abnormality (aspartate transaminase [AST] or alanine transaminase [ALT] levels greater than two-fold the normal level)
9. Renal function abnormality (serum creatinine or blood urea nitrogen [BUN] levels greater than two-fold the normal level)
10. Pregnancy or breastfeeding
11. Mental illness resulting in inability to comply with the clinical trial protocol
12. Any other condition rendering the individual unsuitable for inclusion in the trial, as determined by the principle investigator (PI)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Facial Disability Index (FDI)
- Secondary Outcome Measures
Name Time Method House-Brackmann Grade (HB-Gr);Facial Nerve Grading System 2.0 (FNGS 2.0);Sunnybrook Facial Grading System;facial stiffness score;lip mobility score;treatment satisfaction score