Clinical trial NCT05270187: Multiwave Locked System Laser for Patients With Bell's Palsy.
Official title: Efficacy of Multiwave Locked System Laser on Recovery of Patients With Bell's Palsy: A Randomized Placebo Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Facial Paralyses, Idiopathic
Laser Therapy
Bell Palsy
Keywords: Bell's palsy
Multiwave locked system laser therapy
facial disability scale
House-Brackmann scale
Lead sponsor: Umm Al-Qura University
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 60 recruited patients will be randomly assigned into three groups of 20 patients in each. Group one will receive MLS laser therapy with 10 J/cm2 in scanning mode to the affected side plus facial massage and exercises. Group two will receive MLS laser therapy to predetermined eight motor points to facial muscles plus facial massage and exercises. Group three will receive placebo laser plus facial massage and exercises.
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Facial disability scale (FDI)
timeFrame: The scores of the questionnaire will be collected at the baseline before treatment.
measure: Facial disability scale (FDI)
timeFrame: The scores of the questionnaire will be collected after three weeks after treatment.
measure: Facial disability scale (FDI)
timeFrame: The scores of the questionnaire will be collected after six weeks after treatment.
Secondary outcomes:
measure: House-Brackmann scale (HBS)
timeFrame: The scores of the questionnaire will be collected at the baseline before starting of the treatment
measure: House-Brackmann scale HBS
timeFrame: The scores of the questionnaire will be collected after three weeks after treatment.
measure: House-Brackmann scale HBS
timeFrame: The scores of the questionnaire will be collected after six weeks after treatment.
Other outcomes:
Locations:
city: Mecca
country: Saudi Arabia
facility: Umm Al-Qura University, Faculty of Applied Medical Science
Study officials:
affiliation: Associate Professor of Physical Therapy, Faculty of Applied Medical Science
name: Mohamed Alayat
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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. doi: 10.1093/ptj/76.12.1288.
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. doi: 10.1097/00129492-200301000-00023.
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 2010 Jan 21.