Bell's Palsy With a Duration of Greater Than 8 Weeks Treated With Multiwave Locked System Intervention

NCT05846217 | Completed

• 1 other identifier: Laser-Bell-2023
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVE: To determine whether photobiomodulation therapy by class IV Multiwave Locked System laser treatment could relieve symptoms in patients with Bell's palsy with a duration of greater than 8 weeks. METHODS AND METHODS: This randomized controlled trial from May 2021 to April 2023. Patients were eligible who had Bell's palsy with a duration of greater than 8 weeks on out-patient department of otorhinolaryngology in Beijing Tongren Hospital. The photobiomodulation group received class IV Multiwave Locked System laser treatment for 3 times per weeks, a total of 6 months. The control group received the same Multiwave Locked System treatment procedure except the laser parameter. The primary outcome measures comprised House-Brackmann facial nerve grading system, Sunnybrook facial grading system, Facial Clinimetric Evaluation Scale. Secondary outcome measures comprised Electroneurography, Electromyography, and the Blink Reflex.

Conditions

Bell's Palsy

Keywords

Bell'palsy; photobiomodulation; RCT; ENoG; EMG

Outcome Measures

Primary Outcomes (2)

• House-Brackmann grading system

  The House-Brackmann facial nerve grading system (HB grading) is based on a 6-grade score that offers a gross evaluation of facial motor function and includes the evaluation of sequelae. The prognoses of patients with House- Brackmann grade I or grade II were considered good, and the prognoses of those with grade 3 or higher were considered poor.

  Change from Baseline number of pathological HB grading at 6-months in post-therapy.

• electroneuronography

  The goal of the Electroneurography (ENoG) testing is to measure the amount of neural degradation that has occurred distal to the site of facial nerve injury by measuring the muscle response to an electrical stimulus. The testing of ENoG involves recording the compound muscle action potential (CAMP) of the mimetic muscles, including Orbicularis oculi, Frontalis muscle, Orbicularis oris and Zygomaticus muscle. ENoG is performed first on the healthy side of the face and then on the affected side. Nerve damage or nerve fiber degeneration leads to a decrease or loss of the CAMP. The amplitude of the CAMP on the affected side is compared to the CAMP of the healthy side and expressed as percent (amplitude of the paralyzed side divided by the amplitude of the normal side). A side difference of 30% or bigger is considered pathologic.

  Change from Baseline amplitude and potential of CAMP and the numbers of pathological ENoG at at 6-months in post-therapy.]

Secondary Outcomes (3)

• Sunnybrook Facial Grading Scale

  Change from Baseline number of pathological SB grading at 6-months in post-therapy.

• electromyography

  Change from Baseline amplitude and duration of MUAPs at at 6-months in post-therapy.

• Blink Reflex

  Change from Baseline number of pathological Blink Reflex at 6-months in post-therapy

Study Arms (2)

PBMT Group

EXPERIMENTAL

In PBMT group, we choose 9 points on the affected face, include Mastoid, Preauricular, Temple, Frontalis muscle, Zygomatic muscle, Buccinator muscle, Masseter, Orbicularis oris and Depressor angulli oris. Based on clinical experience, we choose 7 acupoints, including LI4 (HeGu), LI11(QuChi), ST25 (TianShu), ST36 (ZuSanLi), SP6 (SanYinJiao), KI3 (TaiXi), LR3 (TaiChong). All the acupoint were applied bilaterally. Laser divice directly contacts the points. All those points near the superficial roots of facial nerve. At each point, we treated for 1min, 1500 Hz, 50% laser intensity. And patients in PBMT group wore safety glasses to prevent eye damage during the laser sessions. All treatments were performed in the outpatient clinic by the same physician.

Device: Multiwave Locked System

Control Group

SHAM COMPARATOR

Patients in the control group received no intervention but were free to pursue therapies if desired.

Device: Multiwave Locked System

Interventions

Multiwave Locked System DEVICE

Multiwave Locked System laser is a class IV NIR laser with two synchronized sources (905 nm with 75 W peak power, pulsed mode; 808 nm with power 1 W, continuous mode). Both laser beams were synchronized, the locked waves work with the range 1-2000 Hz.

Control Group; PBMT Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients were eligible for House-Brackmann grading system (HB) greater than or equal to grade 3.
• Patients were adults over 18 years of age and under 60 years of age;
• Patients were not received medicine before 2 weeks of trial, such as prednisolone.

You may not qualify if:

• Patients were excluded HB grade 6, or greater than 90% denervation on electroneuronography, or no voluntary electromyography activity, or no latency of early (R1) and late (R2, R2') components in Blink Reflex patients.
• Patients were excluded serious mental illness or social problems, and neurological disorders. And systemic disease, such as severe diabetes, malignant tumors, and other serious consumptive diseases, planning for pregnancy, in pregnancy or lactation.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing TongRen Hospital, Capital Medical University

Beijing, China

Location

Related Publications (1)

• Wu D, Lan X, Litscher G, Zhao YL, Wu YQ, Dai RJ, Cao K, Wang Y, Chen LQ. Laser acupuncture and photobiomodulation therapy in Bell's palsy with a duration of greater than 8 weeks: a randomized controlled trial. Lasers Med Sci. 2024 Jan 13;39(1):29. doi: 10.1007/s10103-023-03970-4.

  PMID: 38216803 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 6, 2023
• Study Start: May 1, 2021
• Primary Completion: February 28, 2023
• Study Completion: April 10, 2023
• Last Updated: June 16, 2026

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

CN (1)