Clinical trial NCT03592797: Effect of Laser Acupuncture Treatment on Chronic Facial Paralysis
Official title: Effect of Laser Acupuncture Treatment on Chronic Facial Paralysis: A Randomized Sham Control, Double Blind Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bell Palsy
Idiopathic Facial Paralyses
Keywords: Low-level laser therapy
Laser acupuncture
Sequelae of Bell's palsy
Randomized controlled trial
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, sham control, double blind pilot study
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed patients with Bell's palsy (ICD9- CM 351.0) with at least 3 months prior to screening.
2. Age- above 20 years old
3. Facial disability index (FDI) less than 80 on FDI physical subscale and less than 80 on the FDI social subscale.

Exclusion Criteria:

1. Patients with any of the following are excluded: uncontrolled hypertension, diabetes mellitus requiring insulin injection, other neurological diseases, patients with multiple cranial nerve palsies, pregnancy or breastfeeding woman, will be excluded.
2. Patients with other types of facial palsy or other known causes than Bell's palsy-Ramsay Hunt syndrome, cholesteatoma, Otitis media, traumatic facial palsy, iatrogenic facial palsy or parotid tumor will be excluded.
3. Patients with recurrent facial palsy or patients who have pre-existing facial deformity, contracture, synkinesis, and spasm for whatever reason will be excluded.
4. Patients with the following will be excluded:

Surgery: a surgical history for facial palsy, such as facial nerve decompression, reconstruction of the facial nerve or muscle within 3 months.

Primary outcomes:
measure: The change in the Facial Disability Index (FDI)
timeFrame: Assessment will take place at baseline, end of third week and six week.
Secondary outcomes:
measure: The change in the House-Brackmann (H-B) facial nerve grading system
timeFrame: Assessment will take place at baseline, end of third week and six week.
measure: The change in the Sunnybrook (S-B) facial nerve grading system
timeFrame: Assessment will take place at baseline, end of third week and six week.
measure: The change in the stiffness scale
timeFrame: Assessment will take place at baseline and end of six week.
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Yu-Chen Lee, M.D PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ton G, Lee LW, Ng HP, Liao HY, Chen YH, Tu CH, Tseng CH, Ho WC, Lee YC. Efficacy of laser acupuncture for patients with chronic Bell's palsy: A study protocol for a randomized, double-blind, sham-controlled pilot trial. Medicine (Baltimore). 2019 Apr;98(15):e15120. doi: 10.1097/MD.0000000000015120.