search
Back to results

Effect of Laser Acupuncture Treatment on Chronic Facial Paralysis

Primary Purpose

Bell Palsy, Idiopathic Facial Paralyses

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Laser acupuncture therapy
Sham laser acupuncture therapy
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bell Palsy focused on measuring Low-level laser therapy, Laser acupuncture, Sequelae of Bell's palsy, Randomized controlled trial

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Laser acupuncture therapy group

Sham laser acupuncture therapy group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
June 11, 2018
Last Updated
December 21, 2020
Sponsor
China Medical University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03592797
Brief Title
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

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 5, 2018 (Actual)
Primary Completion Date
July 20, 2020 (Actual)
Study Completion Date
December 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bell Palsy, Idiopathic Facial Paralyses
Keywords
Low-level laser therapy, Laser acupuncture, Sequelae of Bell's palsy, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, sham control, double blind pilot study
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Sham laser acupuncture group
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser acupuncture therapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham laser acupuncture therapy group
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Laser acupuncture therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham laser acupuncture therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change in the Facial Disability Index (FDI)
Description
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.
Time Frame
Assessment will take place at baseline, end of third week and six week.
Secondary Outcome Measure Information:
Title
The change in the House-Brackmann (H-B) facial nerve grading system
Description
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.
Time Frame
Assessment will take place at baseline, end of third week and six week.
Title
The change in the Sunnybrook (S-B) facial nerve grading system
Description
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.
Time Frame
Assessment will take place at baseline, end of third week and six week.
Title
The change in the stiffness scale
Description
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.
Time Frame
Assessment will take place at baseline and end of six week.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Chen Lee, M.D PhD
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30985671
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.
Results Reference
derived

Learn more about this trial

Effect of Laser Acupuncture Treatment on Chronic Facial Paralysis

We'll reach out to this number within 24 hrs