NCT03592797

Effect of Laser Acupuncture Treatment on Chronic Facial Paralysis

Effect of Laser Acupuncture Treatment on Chronic Facial Paralysis: A Randomized Sham Control, Double Blind Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Inadequate recovery from Bell's palsy is not uncommon and as consequence, physical and social impairment are exist in these patients. The medical options for chronic condition of Bell's 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 Bell's palsy and during the chronic stage is unclear.

Detailed description

Background: Inadequate recovery from Bell's palsy is not uncommon and as consequence, physical and social impairment are exist in these patients. The medical options for chronic condition of Bell's 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 Bell's 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 Bell's palsy with the following two groups: LAT (N=16) and a sham LAT (N=16). 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.

Conditions

• Bell Palsy
• Idiopathic Facial Paralyses

Interventions

Type	Name	Description
OTHER	Laser acupuncture therapy	Low level laser therapy to stimulate acupuncture points: Total 11 points will be used in the study. 7 points ST4, ST6, ST7, SI18, BL2, GB14, SJ17 located in the effected side of the face and will be stimulated ipsilateral. Two points ST36, LI4 located distally and will be stimulated bilateral.
OTHER	Sham laser acupuncture therapy	Sham procedure of Low level laser therapy to stimulate acupuncture points is identical procedure as the intervention group. The same 11 points which mention above will be used, However, in the sham group the laser device will be deactivated and won't produce any laser beam irradiation.

Timeline

• Start date: 2018-05-05
• Primary completion: 2020-07-20
• Completion: 2020-12-09
• First posted: 2018-07-19
• Last updated: 2020-12-22

Locations

1 site across 1 country: Taiwan