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Effect of Laser Acupuncture Treatment on Chronic Facial Paralysis

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ClinicalTrials.gov Identifier: NCT03592797
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

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.

Condition or disease Intervention/treatment Phase
Bell Palsy Idiopathic Facial Paralyses Other: Laser acupuncture therapy Other: Sham laser acupuncture therapy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, sham control, double blind pilot study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Sham laser acupuncture group
Primary Purpose: Treatment
Official Title: Effect of Laser Acupuncture Treatment on Chronic Facial Paralysis: A Randomized Sham Control, Double Blind Pilot Study
Actual Study Start Date : May 5, 2018
Estimated Primary Completion Date : March 21, 2019
Estimated Study Completion Date : March 21, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Laser acupuncture therapy group
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
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.

Sham Comparator: Sham laser acupuncture therapy group
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
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 Measures :
  1. The change in the Facial Disability Index (FDI) [ Time Frame: Assessment will take place at baseline, end of third week and six week. ]
    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 :
  1. The change in the House-Brackmann (H-B) facial nerve grading system [ Time Frame: Assessment will take place at baseline, end of third week and six week. ]
    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.

  2. The change in the Sunnybrook (S-B) facial nerve grading system [ Time Frame: Assessment will take place at baseline, end of third week and six week. ]
    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.

  3. The change in the stiffness scale [ Time Frame: Assessment will take place at baseline and end of six week. ]
    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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592797


Contacts
Contact: Yu-Chen Lee, M.D PhD 886-975-682023 d5167@mail.cmuh.org.tw

Locations
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Yu-Chen Lee, Doctor    0975-682023    d5167@mail.cmuh.org.tw   
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Yu-Chen Lee, M.D PhD China Medical University Hospital

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03592797     History of Changes
Other Study ID Numbers: CMUH107-REC1-030
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by China Medical University Hospital:
Low-level laser therapy
Laser acupuncture
Sequelae of Bell's palsy
Randomized controlled trial

Additional relevant MeSH terms:
Facies
Paralysis
Facial Paralysis
Bell Palsy
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mouth Diseases
Stomatognathic Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Facial Nerve Diseases
Cranial Nerve Diseases