Effect of Laser Acupuncture Treatment on Chronic Facial Paralysis

NCT03592797 | Completed

• 1 other identifier: CMUH107-REC1-030
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Bell Palsy; Idiopathic Facial Paralyses

Keywords

Low-level laser therapy; Laser acupuncture; Sequelae of Bell's palsy; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The change in the House-Brackmann (H-B) facial nerve grading system

  Assessment will take place at baseline, end of third week and six week.

• The change in the Sunnybrook (S-B) facial nerve grading system

  Assessment will take place at baseline, end of third week and six week.

• The change in the stiffness scale

  Assessment will take place at baseline and end of six week.

Study Arms (2)

Laser acupuncture therapy group

EXPERIMENTAL

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

Sham laser acupuncture therapy group

SHAM COMPARATOR

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

Interventions

Laser acupuncture therapy OTHER

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.

Laser acupuncture therapy group

Sham laser acupuncture therapy OTHER

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.

Sham laser acupuncture therapy group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 30985671 DERIVED

MeSH Terms

Conditions

Bell Palsy

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Yu-Chen Lee, M.D PhD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sham laser acupuncture group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, sham control, double blind pilot study

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: July 19, 2018
• Study Start: May 5, 2018
• Primary Completion: July 20, 2020
• Study Completion: December 9, 2020
• Last Updated: December 22, 2020

Record last verified: 2020-12

Locations

TW (1)