Effect of Laser Acupuncture Treatment on Chronic Facial Paralysis

NCT ID: NCT03592797

Last Updated: 2020-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-05
• Study Completion Date: 2020-12-09

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.

Conditions

Bell Palsy; Idiopathic Facial Paralyses

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Laser acupuncture therapy

Intervention Type: 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.

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

Group Type: SHAM_COMPARATOR

Sham laser acupuncture therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu-Chen Lee, M.D PhD

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 30985671 (View on PubMed)

Other Identifiers

CMUH107-REC1-030

Identifier Type: -

Identifier Source: org_study_id