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

NCT05270187 | Unknown DMC

• 1 other identifier: 22-MED-10023150
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Facial Paralyses, Idiopathic; Laser Therapy; Bell Palsy

Keywords

Bell's palsy; Multiwave locked system laser therapy; facial disability scale; House-Brackmann scale

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (3)

• House-Brackmann scale (HBS)

  The scores of the questionnaire will be collected at the baseline before starting of the treatment

• House-Brackmann scale HBS

  The scores of the questionnaire will be collected after three weeks after treatment.

• House-Brackmann scale HBS

  The scores of the questionnaire will be collected after six weeks after treatment.

Study Arms (3)

Scanning Gorup

EXPERIMENTAL

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.

Other: Photobiomodulation therapy (laser therapy); Other: Facial massage and facial expression exercises

Point laser Group

EXPERIMENTAL

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.

Other: Photobiomodulation therapy (laser therapy); Other: Facial massage and facial expression exercises

Control Group

PLACEBO COMPARATOR

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.

Other: Facial massage and facial expression exercises

Interventions

Photobiomodulation therapy (laser therapy) OTHER

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.

Also known as: Multiwave Locked System Laser

Point laser Group; Scanning Gorup

Facial massage and facial expression exercises OTHER

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.

Also known as: Exercises

Control Group; Point laser Group; Scanning Gorup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Umm Al-Qura University, Faculty of Applied Medical Science

Mecca, 21955, Saudi Arabia

RECRUITING

Related 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.

  PMID: 23709010 RESULT

• 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.

  PMID: 28783464 RESULT

• 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.

  PMID: 16565685 RESULT

• 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.

  PMID: 8959998 RESULT

• 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.

  PMID: 12544040 RESULT

• 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.

  PMID: 20093325 RESULT

MeSH Terms

Conditions

Bell Palsy

Interventions

Low-Level Light Therapy; Laser Therapy; Exercise

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Phototherapy; Ablation Techniques; Surgical Procedures, Operative; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mohamed Alayat

  Associate Professor of Physical Therapy, Faculty of Applied Medical Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed S Alayat, Ph.D

CONTACT

+966566003665; mohsalahpt@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Therapy

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: March 8, 2022
• Study Start: January 10, 2022
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: March 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)