Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573697
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-24
Brief Title:
EA Treatment With Different Waveform for Subacute BPStudy Protocol for a Randomized Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Treatment of Electroacupuncture With Different Waveform for Subacute Peripheral Facial ParalysisStudy Protocol for a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Bell palsy BP is a relatively common clinical disease which leads to functional and esthetic disturbances for patients and results in a lowered quality of life Electroacupuncture received attention in the management of BP The aim of this study is to evaluate the curative effect of different waveform of electroacupuncture on peripheral facial paralysis in subacute stage and to screen out the optimal waveform
Detailed Description:
This parallel-group multicenter randomized clinical trial RCT will be conducted at the outpatient clinic of three hospitals in ChinaA total of ninety eligible patients will be randomly divided into low frequency continuous waven30 discontinuous waven30 and dilatational wave n30 groupsAll groups will receive traditional acupuncture treatment at selected acupoints BL2GB1GB14ST2SI18ST4ST6ST7SJ17EX-HN16EX-HN5LI4additionallyreceive different waveform of electroacupuncture treatment for 20 minutes three times per week for four weeksFacial Nerve Grading System 20 FNGS 20 will be used to assess the curative effect at baseline and at 4 weeks after treatment as the primary outcomeSunnybrook facialgrad-ingsystemSFGS and Facial Disability Index FDIScale will be measured and analyzed at baseline and at 4 weeks after treatment as secondary outcomesIn additionamplitude ratio of the affectedhealthy side will be another secondary outcome tested by ENoG at bsaeline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None