Ignite Creation Date:
2024-05-06 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03592797
Status:
COMPLETED
Last Update Posted:
2020-12-22
First Post:
2018-06-11
Brief Title:
Effect of Laser Acupuncture Treatment on Chronic Facial Paralysis
Sponsor:
China Medical University Hospital
Organization:
China Medical University Hospital
Study Overview
Official Title:
Effect of Laser Acupuncture Treatment on Chronic Facial Paralysis A Randomized Sham Control Double Blind Pilot Study
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Inadequate recovery from Bells palsy is not uncommon and as consequence physical and social impairment are exist in these patients The medical options for chronic condition of Bells palsy are insufficient Low-level laser therapy has shown a favorable prognosis in the regeneration of peripheral nerves Moreover laser acupuncture therapy LAT become widely used method to stimulate acupuncture points but its efficacy as treatment method for Bells palsy and during the chronic stage is unclear
Detailed Description:
Background Inadequate recovery from Bells palsy is not uncommon and as consequence physical and social impairment are exist in these patients The medical options for chronic condition of Bells palsy are insufficient Low-level laser therapy has shown a favorable prognosis in the regeneration of peripheral nerves Moreover laser acupuncture therapy LAT become widely used method to stimulate acupuncture points but its efficacy as treatment method for Bells palsy and during the chronic stage is unclear
Methods This clinical trial settings are a randomized placebo control double blind pilot study including patients with the unsatisfactory recovery of Bells palsy with the following two groups LAT N16 and a sham LAT N16 The LAT will receive treatments for 6 weeks compare to sham control group The primary outcome measure will be change in the Facial Disability Index at week 6 Statistical analysis will also include changes in the House-Brackmann grading system the Sunnybrook grading system and stiffness scale at 1 3 and 6 weeks after randomization
Expected outcome The investigators hypothesis that LAT will have an effect on functional outcomes in patients with chronic facial paralysis Moreover changes in the S-B facial nerve grading system is also expected to have an improvement Last social subscale of FDI is expected to have an improvement
Methods This clinical trial settings are a randomized placebo control double blind pilot study including patients with the unsatisfactory recovery of Bells palsy with the following two groups LAT N16 and a sham LAT N16 The LAT will receive treatments for 6 weeks compare to sham control group The primary outcome measure will be change in the Facial Disability Index at week 6 Statistical analysis will also include changes in the House-Brackmann grading system the Sunnybrook grading system and stiffness scale at 1 3 and 6 weeks after randomization
Expected outcome The investigators hypothesis that LAT will have an effect on functional outcomes in patients with chronic facial paralysis Moreover changes in the S-B facial nerve grading system is also expected to have an improvement Last social subscale of FDI is expected to have an improvement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None