Clinical efficacy and safety of thread-embedding acupuncture for treatment of the sequelae of Bell’s palsy

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002557

Enrollment

Registered

2017-11-24

Start date

2017-10-16

Completion date

Unknown

Last updated

2019-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Thread-embedding therapy (TET) group and sham thread-embedding therapy (STET) will receive manual acupuncture treatment (MAT) 2 times/week over 8 weeks, following the details of th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

Measure	Time frame
Facial Disability Index (FDI)	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactYeoncheol Park

Kyung Hee University Oriental Medicine Hospital at Gangdong

icarus08@hanmail.net+82-2-440-6275

Outcome results