Multiwave Locked System Laser for Patients With Bell's Palsy.

Bell Palsy Clinical Trial

— MLS  

Official title:

Efficacy of Multiwave Locked System Laser on Recovery of Patients With Bell's Palsy: A Randomized Placebo Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05270187
• Other study ID #: 22-MED-10023150
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: April 2022

Study information

• Verified date: March 2022
• Source: Umm Al-Qura University
• Contact: Mohamed S Alayat, Ph.D
• Phone: +966566003665
• Email: mohsalahpt[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Idiopathic Bell's palsy (IBP) is a unilateral facial paralysis of sudden onset and unknown etiology. Patient with IBP has an impaired facial expressions and psychological affection, which interfere with social communication. Multiwave locked system (MLS) laser therapy is a class IV laser with synchronizes emission of an 808 nm continuous laser and a 905 nm pulsed laser. It is proposed that MLS facilitates greater penetration and therapeutic effects than low-level laser therapy (LLLT).

Aims: The aim of present study is to investigate the effect of MLS laser in the treatment of patients with unilateral IBP.

Participant: A total number of 60 patients with IBP will be recruited from Makkah hospitals. Treatment will begin in the subacute phase as they referred from neuro-doctors. All the recruited patients will be randomly assigned into three groups of 20 patients each.

Intervention: All patients will be treated with facial massage and exercises. In addition, group one will receive MLS laser with 10 J/cm2 in scanning mode while the group two will receive 10J/point for eight points.

Measured variables: Facial disability scale (FDI) and House-Brackmann scale HBS will used to assess the grade of facial nerve recovery. The scores of both questionnaires will be collected at the baseline, after three and six weeks after treatment.

Statistical Analysis: The Friedman and Wilcoxon signed ranks tests will be used to compare the FDI and HBS scores within each group

Description:

Multi-wave locked system (MLS) laser therapy had been presented in the arena of rehabilitation and attained interests of numerous researchers due to its unique features. MLS laser is a Class IV, high-power laser, which is characterized by a combination of two waveforms of continuous emissions of an 808 nm wavelength and a pulsed 905 nm emitted in synchrony. MLS used recently in research and revealed significant reduction of musculoskeletal pain and disability. Researchers recommend its use in case of muscle lesions and/or diseases. No proved way was shown to use laser in the treatment of facial palsy in either scanning the affected side or applying laser to specific motor points.

It was proposed that the combination of the dual laser waveforms offers better penetrability and outcomes on than ordinary lasers and help in recovery of facial muscle.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any patient who has unilateral IBP either on the right or left side.

• Treatment will begin in the sub-acute stage of illness 3-5 days after the acute onset subsided.

• patients will accept to attend to the physical therapy department to receive their corresponding treatment twice a week for successive six weeks.

Exclusion Criteria:

• Patients who have central nervous system pathology

• sensory loss over the face, or recurrence of BP.

• Patients with upper motor facial nerve palsy will be also excluded.

• Any infant or child (=18 years) with BP will be also excluded.

• Chronic facial palsy patients

• Patients BP having after a tumor, stroke, and Lyme disease will be excluded.

Related Conditions & MeSH terms

• Bell Palsy
• Facial Paralysis
• Laser Therapy
• Paralysis

Intervention

Other:
• Photobiomodulation therapy (laser therapy)
The Multiwave Locked System Laser will treat both the scan and point application groups. M6 laser equipment (ASA, Arcugnano, Italy) is used in this study in the physiotherapy and rehabilitation department, Faculty of Applied Medical Science, Umm Al-Qura University. It provides synchronized and overlapping continuous and pulsed emissions of Ga-Al-Ar laser emitted in a single hand piece. M6 has a continuous emission of a wavelength of 808 nm with peak power of 1000 mW, mean power of 500mW, spot diameter of 2 cm, and spot area of 3.14 cm2. Pulsed emission has a wavelength of 905 nm, peak power of 25 W, and mean power of 54mW with frequency of 1500 Hz.
• Facial massage and facial expression exercises
Facial massage and facial expression exercises will be applied for all patients in the three treatment groups. It includes simple facial expression exercises, active graduated strengthening exercises in front of a mirror (active assisted, freedom, and resisted), proprioceptive neuromuscular facilitation exercises for facial muscles, and resisted exercises for neck muscles. Participants are taught to perform massage and exercises correctly by the physiotherapist. All treatment groups are given instruction to repeat the massage and exercises two times a day for at least 6 weeks. The patient or one of his/her family members will confirm that the participant carries out the massage and exercises at home.

Locations

Country	Name	City	State
Saudi Arabia	Umm Al-Qura University, Faculty of Applied Medical Science	Mecca

Sponsors (1)

Lead Sponsor	Collaborator
Umm Al-Qura University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (6)

Alayat MS, Elsodany AM, El Fiky AA. Efficacy of high and low level laser therapy in the treatment of Bell's palsy: a randomized double blind placebo-controlled trial. Lasers Med Sci. 2014 Jan;29(1):335-42. doi: 10.1007/s10103-013-1352-z. Epub 2013 May 26. — View Citation

Alayat MS, Elsoudany AM, Ali ME. Efficacy of Multiwave Locked System Laser on Pain and Function in Patients with Chronic Neck Pain: A Randomized Placebo-Controlled Trial. Photomed Laser Surg. 2017 Aug;35(8):450-455. doi: 10.1089/pho.2017.4292. — View Citation

Lindsay RW, Robinson M, Hadlock TA. Comprehensive facial rehabilitation improves function in people with facial paralysis: a 5-year experience at the Massachusetts Eye and Ear Infirmary. Phys Ther. 2010 Mar;90(3):391-7. doi: 10.2522/ptj.20090176. Epub 201 — View Citation

Shafshak TS. The treatment of facial palsy from the point of view of physical and rehabilitation medicine. Eura Medicophys. 2006 Mar;42(1):41-7. Review. — View Citation

VanSwearingen JM, Brach JS. The Facial Disability Index: reliability and validity of a disability assessment instrument for disorders of the facial neuromuscular system. Phys Ther. 1996 Dec;76(12):1288-98; discussion 1298-300. — View Citation

Yen TL, Driscoll CL, Lalwani AK. Significance of House-Brackmann facial nerve grading global score in the setting of differential facial nerve function. Otol Neurotol. 2003 Jan;24(1):118-22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Facial disability scale (FDI)	The FDI was produced by Van Swearingen and Brach to improve the assessment of facial neuromuscular dysfunction. Beyond the impairment domain, this index provides a reliable measurement with construct validity for evaluating patients with facial nerve disorders.	The scores of the questionnaire will be collected at the baseline before treatment.
Primary	Facial disability scale (FDI)	The FDI was produced by Van Swearingen and Brach to improve the assessment of facial neuromuscular dysfunction. Beyond the impairment domain, this index provides a reliable measurement with construct validity for evaluating patients with facial nerve disorders.	The scores of the questionnaire will be collected after three weeks after treatment.
Primary	Facial disability scale (FDI)	The FDI was produced by Van Swearingen and Brach to improve the assessment of facial neuromuscular dysfunction. Beyond the impairment domain, this index provides a reliable measurement with construct validity for evaluating patients with facial nerve disorders.	The scores of the questionnaire will be collected after six weeks after treatment.
Secondary	House-Brackmann scale (HBS)	This scale analyses the symmetry, synkinesis, stiffness, and global mobility of the face [6]. It consists of six divisions (normal, mild dysfunction, moderate dysfunction, moderately severe dysfunction, severe dysfunction, and total paralysis) with grade one indicating a normal facial function in all areas and grade six indicating total paralysis.	The scores of the questionnaire will be collected at the baseline before starting of the treatment
Secondary	House-Brackmann scale HBS	This scale analyses the symmetry, synkinesis, stiffness, and global mobility of the face [6]. It consists of six divisions (normal, mild dysfunction, moderate dysfunction, moderately severe dysfunction, severe dysfunction, and total paralysis) with grade one indicating a normal facial function in all areas and grade six indicating total paralysis.	The scores of the questionnaire will be collected after three weeks after treatment.
Secondary	House-Brackmann scale HBS	This scale analyses the symmetry, synkinesis, stiffness, and global mobility of the face [6]. It consists of six divisions (normal, mild dysfunction, moderate dysfunction, moderately severe dysfunction, severe dysfunction, and total paralysis) with grade one indicating a normal facial function in all areas and grade six indicating total paralysis.	The scores of the questionnaire will be collected after six weeks after treatment.