Effect of Laser Acupuncture Treatment on Chronic Facial Paralysis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bell Palsy, Idiopathic Facial Paralyses

Intervention / Treatment
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* Other: Laser acupuncture therapy
* Other: Sham laser acupuncture therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed patients with Bell's palsy (ICD9- CM 351.0) with at least 3 months prior to screening. Age- above 20 years old Facial disability index (FDI) less than 80 on FDI physical subscale and less than 80 on the FDI social subscale. Exclusion Criteria: 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. 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. Patients with recurrent facial palsy or patients who have pre-existing facial deformity, contracture, synkinesis, and spasm for whatever reason will be excluded. 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, sham control, double blind pilot study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser acupuncture therapy group<br>Each subject in the experimental group will receive laser acupuncture therapy using Handylaser Trion device (RJ Laser, Germany) to stimulate acupuncture points with laser beam irradiation. | Other: Laser acupuncture therapy<br>* 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.<br>|
| Sham Comparator: Sham laser acupuncture therapy group<br>Each subject in the sham control group will receive laser acupuncture therapy using Handylaser Trion device (RJ Laser, Germany). The laser device in the sham group will be deactivated and won't produce any laser beam irradiation on acupuncture points | Other: Sham laser acupuncture therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the Facial Disability Index (FDI) | The primary outcome measurement in this study is the change of FDI after completing 6 weeks of laser acupuncture therapy. FDI scoring system consists of two domains; physical score and social score and each section consists five multiple choice question related to either physical or social issues occurred in the previous month. Subjects will fill up the questionnaire and the assessor will calculate the score according to the calculation in each section; physical section: total score (questions 1--5) minus N divided by N multiple 100 divided 4 equals to total score. social section; total score (questions 6--10) minus N divided by N multiple 100 divided by 5 equals to total score (N equals to number of questions answered). Higher values represent a better outcome. FDI evaluations will be performed on the first visit, the 9th visit and 18th visit and will be compared to the score at baseline. | Assessment will take place at baseline, end of third week and six week. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the House-Brackmann (H-B) facial nerve grading system | The change of H-B facial nerve grading system will be compared after completing 6 weeks of laser acupuncture therapy. H-B facial nerve grading system includes 6 grades of facial paralysis; normal, mild, moderate, moderate severe, severe and complete paralysis. The study assessor asks the patient to move the facial muscles and then according to the result the assessor decides the grade of paralysis. The evaluations will be performed on the first visit, the 9th visit and 18th visit. | Assessment will take place at baseline, end of third week and six week. | 
| The change in the Sunnybrook (S-B) facial nerve grading system | The change of S-B facial nerve grading system will be compared after completing 6 weeks of laser acupuncture therapy. S-B facial nerve grading system includes 3 subscales; resting symmetry (eye, cheek and mouth), symmetry of voluntary muscles and synkinesis. Besides the resting symmetry, in the two others subscales the assessor asks the patient to move the facial muscles and then give a score between 1 to 5 ( 1= unable to move 5= complete moment). Subscales are combined to compute a total score; symmetry of voluntary muscles subscale minus resting symmetry subscale minus synkinesis subscale equals to total score. Higher values represent a better outcome. The evaluations will be performed on the first visit, the 9th visit and 18th visit. | Assessment will take place at baseline, end of third week and six week. | 
| The change in the stiffness scale | The change of the stiffness score will be compared to baseline. The stiffness scale will be hand in each session and the subject will choose one number from a five-point scale (1= no stiffness to 5= very stiff) according to the feeling in the face after receiving laser acupuncture therapy. Higher values represent a worse outcome. | Assessment will take place at baseline and end of six week. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low-level laser therapy, Laser acupuncture, Sequelae of Bell's palsy, Randomized controlled trial