Photobiomodulation Therapy Treatment on Facial Paralysis

NCT05585333 | Completed

• 1 other identifier: PBMT-FP-2022
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: Facial paralysis can be caused by a variety of etiological factors, complete palsy continues for two months, the chance of full recovery is reduced to zero. The aim of this study was to evaluate the effectiveness of photobiomodulation therapy (PBMT) in the in patients undergoing facial paralysis over 8 weeks. Methods: This study was an open-label, not concurrent control study including 54 patients that underwent facial paralysis over 8 weeks. Patients were assigned to the PBMT group and control group, with 27 patients in each group. Laser treatments were applied 3 days a week after recruited. PBMT was delivered using a class IV Multi-wave Locked System that combines with a simultaneous 808 nm continuous emission and 905 nm pulse emission and the maximum peak power was 25 W. Clinical outcome measure comprised the House-Brackmann grading system, Facial Clinimetric Evaluation Scale (FaCE), Sunnybrook facial grading scale (SBFG), and electrophysiological testing, including Electroneuronography (ENoG), Electromyography (EMG) and Blink Reflex. All the measurements were collected at the first day and at the end of study. All reported P values were two-sided and were declared statistically significant when less than 0.05.

Conditions

Facial Paralysis

Keywords

Facial paralysis; photobiomodulation; ENoG; EMG; HB grading

Outcome Measures

Primary Outcomes (3)

• The House-Brackmann Facial Nerve 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.

• The Sunnybrook Facial Grading System

  The Sunnybrook facial grading system (SB grading) is 13-items, self-reported questionnaire that used to evaluate the facial movement of patients. Among the overall 13 items of question, 3 items are resting symmetry, 5 items are symmetry of voluntary movement, and 5 items are synkinesis. Lower scores of Sunnybrook equate to greater severity of facial paralysis symptoms.

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

• Facial Clinimetric Evaluation Scale

  The Facial Clinimetric Evaluation Scale (FaCE) is 15-items, self-reported questionnaire that used to assess facial impairment and disability after facial paralysis. Among the overall 15 items of question, FaCE grouped into six independent domains: social function, facial movement, facial comfort, oral function, eye comfort, and lacrimal control. Each using a five-item Likert scale. A participant circles the most appropriate response to a given statement, whereby 1 corresponds to the lowest function and 5 corresponds to the highest function. The total score is ranged 0 (worst) to 100 (best).

  Change from Baseline scores of FaCE at at 6-months in post-therapy.

Secondary Outcomes (3)

• Electroneuronography (ENoG)

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

• Electromyography (EMG)

  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)

Photobiomodulation Group

EXPERIMENTAL

Treatments were performed with MLS laser (Mphi laser, ASA Srl, Italy). MLS laser is a class IV NIR laser with two synchronized sources (laser diodes). The first one is a pulsed laser diode, emitting at 905 nm, with 25 W peak power. The second laser diode (808 nm) was operated in a continuous mode with power 1 W. Both of the laser beams were synchronized, the locked waves work within the range 1-2000 Hz.

Device: MLS laser

Control Group

NO INTERVENTION

Interventions

MLS laser DEVICE

Treatments were performed with MLS laser (Mphi laser, ASA Srl, Italy). MLS laser is a class IV NIR laser with two synchronized sources (laser diodes). The first one is a pulsed laser diode, emitting at 905 nm, with 25 W peak power. The second laser diode (808 nm) was operated in a continuous mode with power 1 W. Both of the laser beams were synchronized, the locked waves work within the range 1-2000 Hz.

Photobiomodulation Group

Eligibility Criteria

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

You may qualify if:

• \- (1) adults over 18 years of age and under 65 years of age. (2) had not received medicine, such as prednisolone. (3) had history of Bell's palsy, Ramsay Hunt syndrome, traumatic facial paralysis and history of otological surgery.
• (4) Disease duration longer than two months.

You may not qualify if:

• \- (1) Complete facial paralysis (HB 6). (2) Greater than 90% denervation on ENoG. (3) No voluntary EMG activity. (4) No latency of early (R1) and late (R2, R2') components in blink reflex. (5) Serious mental illness or social problems, and neurological disorders. (6) Systemic disease, such as severe diabetes, malignant tumors and other serious consumptive diseases.
• (7) 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, Zhao YL, Sun JY, Dai RJ, Cao K, Qu RK, Wang Y, Wu YQ. A Nonrandomized Trial of the Effects of Near-Infrared Photobiomodulation Therapy on Bell's Palsy with a Duration of Greater Than 8 Weeks. Photobiomodul Photomed Laser Surg. 2023 Sep;41(9):490-500. doi: 10.1089/photob.2023.0056.

  PMID: 37738368 DERIVED

MeSH Terms

Conditions

Facial Paralysis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 18, 2022
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: May 1, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-02

Locations

CN (1)