Facial Paralyses, IdiopathicMLSNCT05270187
Multiwave Locked System Laser for Patients With Bell's Palsy.
A study testing Photobiomodulation therapy (laser therapy) and Facial massage and facial expression exercises in people with Facial Paralyses, Idiopathic and Laser Therapy, run by Umm Al-Qura University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Paralyses, Idiopathic, Laser Therapy, Bell Palsy
- What is being tested?
- Photobiomodulation therapy (laser therapy) and Facial massage and facial expression exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Jan 2022to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Umm Al-Qura University, Faculty of Applied Medical Science
Mecca, 21955
About this study
Official title: Efficacy of Multiwave Locked System Laser on Recovery of Patients With Bell's Palsy: A Randomized Placebo Controlled Trial.
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.
Read more
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
Read the 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.
- Conditions
- Facial Paralyses, Idiopathic, Laser Therapy, Bell Palsy
- Being tested
- Photobiomodulation therapy (laser therapy), Facial massage and facial expression exercises
- Keywords
- Bell's palsy, Multiwave locked system laser therapy, facial disability scale, House-Brackmann scale
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation therapy (laser therapy)Other
Also called Multiwave Locked System Laser
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 exercisesOther
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Facial massage and facial expression exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: The scores of the questionnaire will be collected after six weeks after treatment.
Secondary outcomes (3)
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.
Measured: The scores of the questionnaire will be collected at the baseline before starting of the treatment
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.
Measured: The scores of the questionnaire will be collected after three weeks after treatment.
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.
Measured: The scores of the questionnaire will be collected after six weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start10 Jan 2022
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Facial Paralyses, IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Alayat, Umm Al-Qura University
- Investigators
- Mohamed Alayat, Principal investigator, Associate Professor of Physical Therapy, Faculty of Applied Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270187
- Sponsor's protocol ID
- 22-MED-10023150
- Acronym
- MLS
- Status last verified
- Mar 2022
- First submitted
- 19 Jan 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23709010Alayat 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.
PubMed 28783464Shafshak TS. The treatment of facial palsy from the point of view of physical and rehabilitation medicine. Eura Medicophys. 2006 Mar;42(1):41-7.
PubMed 16565685VanSwearingen 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.
PubMed 8959998Yen 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.
PubMed 12544040Lindsay 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.
PubMed 20093325
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Multiwave Locked System Laser on Recovery of Patients With Bell's Palsy: A Randomized Placebo Controlled Trial.
- ClinicalTrials.gov ID
- NCT05270187
- Acronym / sponsor ID
- MLS / 22-MED-10023150
- Conditions
- Facial Paralyses, Idiopathic, Laser Therapy, Bell Palsy
- Keywords
- Bell's palsy, Multiwave locked system laser therapy, facial disability scale, House-Brackmann scale
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Scanning Gorup | Experimental | Other: Photobiomodulation therapy (laser therapy), Other: Facial massage and facial expression exercisesPatients 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. |
| Point laser Group | Experimental | Other: Photobiomodulation therapy (laser therapy), Other: Facial massage and facial expression exercisesPatients 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. |
| Control Group | Placebo comparator | Other: Facial massage and facial expression exercisespatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation therapy (laser therapy)Also: Multiwave Locked System LaserThe 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. | Other | Point laser Group, Scanning Gorup |
| Facial massage and facial expression exercisesAlso: ExercisesFacial 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. | Other | Control Group, Point laser Group, Scanning Gorup |
Primary outcome
Facial disability scale (FDI)
Time frame: The scores of the questionnaire will be collected at the baseline before treatment.
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)
Time frame: The scores of the questionnaire will be collected after three weeks after treatment.
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)
Time frame: The scores of the questionnaire will be collected after six weeks after treatment.
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.
3 secondary outcomes
House-Brackmann scale (HBS)
Time frame: The scores of the questionnaire will be collected at the baseline before starting of the treatment
House-Brackmann scale HBS
Time frame: The scores of the questionnaire will be collected after three weeks after treatment.
House-Brackmann scale HBS
Time frame: The scores of the questionnaire will be collected after six weeks after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Results publication: PubMed 23709010Alayat 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 publication: PubMed 28783464Alayat 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 publication: PubMed 16565685Shafshak 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 publication: PubMed 8959998VanSwearingen 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 publication: PubMed 12544040Yen 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 publication: PubMed 20093325Lindsay 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Alayat principal investigator
Associate Professor of Physical Therapy, Faculty of Applied Medical Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation therapy (laser therapy) and Facial massage and facial expression exercises in people with Facial Paralyses, Idiopathic and Laser Therapy, run by Umm Al-Qura University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed S Alayat, Ph.D (+966566003665, mohsalahpt@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial disability scale (FDI) (time frame: The scores of the questionnaire will be collected at the baseline before treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05270187, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.