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

Primary Purpose

Facial Paralyses, Idiopathic, Laser Therapy, Bell Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Photobiomodulation therapy (laser therapy)
Facial massage and facial expression exercises
Sponsored by
Umm Al-Qura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Facial Paralyses, Idiopathic focused on measuring Bell's palsy, Multiwave locked system laser therapy, facial disability scale, House-Brackmann scale

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Umm Al-Qura University, Faculty of Applied Medical ScienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Scanning Gorup

Point laser Group

Control Group

Arm Description

Patients in this group will receive facial massage, facial expression exercises and a Multiwave Locked System Laser with energy density 10 J/cm2. Laser will scan the affected side after calculating the distance and the total energy delivered to the one side of the face. The average treatment area is 50 cm2. The energy density was 10 J/cm2 with a total energy of 500 J and the treatment time is approximately 15 minutes. The laser probe will be away from the eye region. Both patients and therapist wear a laser googles.

Patients in this group will received facial massage, facial expression exercises and laser at predetermined eight points on the affected side of the facial muscles. the hand piece is positioned perpendicular to 8 points which is located on the superficial roots of the facial nerve of the affected side. Each point will receive an energy density of 10 J/point with total energy delivered to the patient during one session of 80 joules. The time of application 90 sec/point. laser is calibrated by the manufacture company before the starting the experiment and periodically during the sessions. The laser probe will be away from the eye region. Both patients and therapist wear a laser googles.

patients in this group will receive only facial massage, facial expression exercises and placebo laser. Facial expression exercises include 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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 19, 2022
Last Updated
March 6, 2022
Sponsor
Umm Al-Qura University
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1. Study Identification

Unique Protocol Identification Number
NCT05270187
Brief Title
Multiwave Locked System Laser for Patients With Bell's Palsy.
Acronym
MLS
Official Title
Efficacy of Multiwave Locked System Laser on Recovery of Patients With Bell's Palsy: A Randomized Placebo Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umm Al-Qura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Paralyses, Idiopathic, Laser Therapy, Bell Palsy
Keywords
Bell's palsy, Multiwave locked system laser therapy, facial disability scale, House-Brackmann scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
By sealed envelopes, the allocation concealment will be achieved. Patient randomization is performed simply by computer number generator for each patient using GraphPad software. All eligible participants will be evaluated by independent physician and will be treated by the same therapist. The physician conducts the processes of participant enrollment, and allocation. The same assessors will measure the measured outcome. Both the therapist and the assessor will be blinded (masked) from patient's enrollment into the three study groups.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Scanning Gorup
Arm Type
Experimental
Arm Description
Patients in this group will receive facial massage, facial expression exercises and a Multiwave Locked System Laser with energy density 10 J/cm2. Laser will scan the affected side after calculating the distance and the total energy delivered to the one side of the face. The average treatment area is 50 cm2. The energy density was 10 J/cm2 with a total energy of 500 J and the treatment time is approximately 15 minutes. The laser probe will be away from the eye region. Both patients and therapist wear a laser googles.
Arm Title
Point laser Group
Arm Type
Experimental
Arm Description
Patients in this group will received facial massage, facial expression exercises and laser at predetermined eight points on the affected side of the facial muscles. the hand piece is positioned perpendicular to 8 points which is located on the superficial roots of the facial nerve of the affected side. Each point will receive an energy density of 10 J/point with total energy delivered to the patient during one session of 80 joules. The time of application 90 sec/point. laser is calibrated by the manufacture company before the starting the experiment and periodically during the sessions. The laser probe will be away from the eye region. Both patients and therapist wear a laser googles.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
patients in this group will receive only facial massage, facial expression exercises and placebo laser. Facial expression exercises include 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.
Intervention Type
Other
Intervention Name(s)
Photobiomodulation therapy (laser therapy)
Other Intervention Name(s)
Multiwave Locked System Laser
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Facial massage and facial expression exercises
Other Intervention Name(s)
Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Facial disability scale (FDI)
Description
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.
Time Frame
The scores of the questionnaire will be collected at the baseline before treatment.
Title
Facial disability scale (FDI)
Description
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.
Time Frame
The scores of the questionnaire will be collected after three weeks after treatment.
Title
Facial disability scale (FDI)
Description
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.
Time Frame
The scores of the questionnaire will be collected after six weeks after treatment.
Secondary Outcome Measure Information:
Title
House-Brackmann scale (HBS)
Description
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.
Time Frame
The scores of the questionnaire will be collected at the baseline before starting of the treatment
Title
House-Brackmann scale HBS
Description
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.
Time Frame
The scores of the questionnaire will be collected after three weeks after treatment.
Title
House-Brackmann scale HBS
Description
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.
Time Frame
The scores of the questionnaire will be collected after six weeks after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed S Alayat, Ph.D
Phone
+966566003665
Email
mohsalahpt@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Alayat
Organizational Affiliation
Associate Professor of Physical Therapy, Faculty of Applied Medical Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Umm Al-Qura University, Faculty of Applied Medical Science
City
Mecca
ZIP/Postal Code
21955
Country
Saudi Arabia
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23709010
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.
Results Reference
result
PubMed Identifier
28783464
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.
Results Reference
result
PubMed Identifier
16565685
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.
Results Reference
result
PubMed Identifier
8959998
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.
Results Reference
result
PubMed Identifier
12544040
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.
Results Reference
result
PubMed Identifier
20093325
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.
Results Reference
result

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

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