Clinical efficacy and safety of thread-embedding acupuncture for treatment of the sequelae of Bell’s palsy: a patient-assessor blinded, randomized, controlled, parallel clinical trial

Kyung Hee University0 个研究点目标入组 56 人开始时间: 待定最近更新: 2019年7月17日

试验速览

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•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)

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