Bell's PalsyNCT05585346
Photobiomodulation Therapy for Idiopathic Facial Paralysis
A study testing MLS laser and Oral vitamin B1 in people with Bell's Palsy, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
Objective: Bell's palsy is characterized by acute, unilateral onset that compromises function and esthetics, exerting a considerable impact on the social, professional, and psychological aspects of the lives of affected individuals. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bell's Palsy
- What is being tested?
- MLS laser and Oral vitamin B1
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 20 Feb 2023
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- (1) Clinical diagnosis of Bell's Palsy. (2) Adults over 18 years of age and under 60 years of age.
Who cannot join
- (1) Systemic disease, such as severe diabetes, malignant tumors and other serious consumptive diseases.
- Serious mental illness or social problems, and neurological disorders. (3) Planning for pregnancy, in pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Photobiomodulation Therapy for Idiopathic Facial Paralysis: Nonrandomized Trial Controlled
Objective:
Bell's palsy is characterized by acute, unilateral onset that compromises function and esthetics, exerting a considerable impact on the social, professional, and psychological aspects of the lives of affected individuals. Without treatment, 30% of patients with complete paralysis will not completely recover. Therefore, shortening the recovery time will accelerate the recovery process leading to better results.
Read more
The objective of this study was to determine whether photobiomodulation therapy with laser acupuncture therapy could relieve symptoms in patients with Bell's palsy.
Methods:
This study was an open-label, randomized controlled trial including 96 patients that undergoing Bell's palsy. All the patients received oral vitamin B1.
Patients were assigned to the laser acupuncture (LA) group and control group, with 102 patients in each group. LA group were received 4 weeks of Laser treatment (3 times per week), while control group were received sham laser treatment.
Clinical outcome measure comprised the House-Brackmann grading system, Facial Clinimetric Evaluation Scale (FaCE), Sunnybrook facial grading scale (SBFG), and electrophysiological testing, including Electroneuronography (ENoG), Electromyography (EMG) and Blink Reflex. All the measurements were collected at the first day and at the end of study. All reported P values were two-sided and were declared statistically significant when less than 0.05.
- Conditions
- Bell's Palsy
- Being tested
- MLS laser, Oral vitamin B1
- Keywords
- Idiopathic facial paralysis, Bell's palsy, photobiomodulation, RCT
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLS laserDevice
Treatments were performed with MLS laser (Mphi laser, ASA Srl, Italy). MLS laser is a class IV NIR laser with two synchronized sources (laser diodes). The first one is a pulsed laser diode, emitting at 905 nm, with 25 W peak power. The second laser diode (808 nm) was operated in a continuous mode with power 1 W. Both of the laser beams were synchronized, the locked waves work within the range 1-2000 Hz.
Oral vitamin B1Drug
Oral vitamin B1 10mg, times/day
| Study group | Role | What they receive |
|---|---|---|
| Laser acupuncture Group | Experimental | LA group used a class IV Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy). MLS laser is a class IV NIR laser with two synchronized sources (905 nm with 75 W peak power, pulsed mode; 808 nm with power 1 W, continuous mode). Both laser beams were synchronized, the locked waves work with the range 1-2000 Hz.
In LA group, based on clinical experience, we choose 5 acupoints on the affected side. It includes ST2(Si Bai), ST4(Di Cang), ST6(Jia Che), GB14(Yang Bai), GB20(Feng chi). We choose 7 acupoints, including LI4 (He Gu), LI11(Qu Chi), ST25 (Tian Shu), ST36 (Zu San Li), SP6 (San Yin Jiao), KI3 (Tai Xi), LR3 (Tai Chong). The acupoints in the limbs and trunk area, were applied bilaterally. Power of laser device is 50%.
Oral vitamin B1. Receives: Device: MLS laser; Drug: Oral vitamin B1 |
| Control Group | Active comparator | LA group used a class IV Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy). MLS laser is a class IV NIR laser with two synchronized sources (905 nm with 75 W peak power, pulsed mode; 808 nm with power 1 W, continuous mode). Both laser beams were synchronized, the locked waves work with the range 1-2000 Hz.
In LA group, based on clinical experience, we choose 5 acupoints on the affected side. It includes ST2(Si Bai), ST4(Di Cang), ST6(Jia Che), GB14(Yang Bai), GB20(Feng chi). We choose 7 acupoints, including LI4 (He Gu), LI11(Qu Chi), ST25 (Tian Shu), ST36 (Zu San Li), SP6 (San Yin Jiao), KI3 (Tai Xi), LR3 (Tai Chong). The acupoints in the limbs and trunk area, were applied bilaterally. Power of laser device is 25%.
Oral vitamin B1. Receives: Device: MLS laser; Drug: Oral vitamin B1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The House-Brackmann Facial Nerve Grading System
The House-Brackmann facial nerve grading system (HB grading) is based on a 6-grade score that offers a gross evaluation of facial motor function and includes the evaluation of sequelae. The prognoses of patients with House-Brackmann grade I or grade II were considered good, and the prognoses of those with grade 3 or higher were considered poor.
Measured: Change from Baseline number of pathological HB grading at 4-weeks in post-therapy.
The Sunnybrook Facial Grading System
The Sunnybrook facial grading system (SB grading) is 13-items, self-reported questionnaire that used to evaluate the facial movement of patients. Among the overall 13 items of question, 3 items are resting symmetry, 5 items are symmetry of voluntary movement, and 5 items are synkinesis. Lower scores of Sunnybrook equate to greater severity of facial paralysis symptoms.
Measured: Change from Baseline scores of SB grading at at 4-weeks in post-therapy.
Secondary outcomes (3)
Electroneuronography (ENoG)
The goal of the Electroneurography (ENoG) testing is to measure the amount of neural degradation that has occurred distal to the site of facial nerve injury by measuring the muscle response to an electrical stimulus. The testing of ENoG involves recording the compound muscle action potential (CAMP) of the mimetic muscles, including Orbicularis oculi, Frontalis muscle, Orbicularis oris and Zygomaticus muscle.
ENoG is performed first on the healthy side of the face and then on the affected side. Nerve damage or nerve fiber degeneration leads to a decrease or loss of the CAMP. The amplitude of the CAMP on the affected side is compared to the CAMP of the healthy side and expressed as percent (amplitude of the paralyzed side divided by the amplitude of the normal side). A side difference of 30% or bigger is considered pathologic.
Measured: Change from Baseline amplitude and potential of CAMP and the numbers of pathological ENoG at at 4-weeks in post-therapy.
Electromyography (EMG)
EMG is an electrophysiologic measures that indirectly quantify facial nerve function by recording motor unit action potentials (MUAPs) in the muscle of Musculus depressor angulli oris, Frontalis muscle and Orbicularis oris. MUAPs are the spikes in electrical activity generated when a motor unit fires. A motor unit consists of a motor neuron and the corresponding muscle fibers innervated by the neuron.
Measured: Change from Baseline amplitude and duration of MUAPs at at 4-weeks in post-therapy.
Blink Reflex
The blink reflex test is to measures the facial nerve since the blink reflex delivers information on facial nerve function with normal trigeminal function. Blink reflex testing involves electrical stimulation of the supraorbital nerve on the affected side combined with a 2-channel simultaneous sEMG recording from both orbicularis oculi muscles. The exit of the supraorbital nerve in the supraorbital foramen is palpated on the rim of the orbit. Stimulation with 10-20 mA and 0.2 ms duration is used to produce a constant reflex.
In blink reflex testing, two responses, R1 and R2, are analyzed. R1 is the fast ipsilateral response of the orbicularis oculi muscle with a latency of about 10-12 ms. The second bilateral response R2 has a latency of about 30-41 ms.
The R2 latency differences between both sides higher than 5-8 ms is considered pathologic.
Measured: Change from Baseline number of pathological Blink Reflex at 6-months in post-therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Jan 2021
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bell's PalsyStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585346
- Sponsor's protocol ID
- PBMT-IFP-2022
- Status last verified
- Feb 2022
- First submitted
- 14 Oct 2022
- Last updated
- 24 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation Therapy for Idiopathic Facial Paralysis: Nonrandomized Trial Controlled
- ClinicalTrials.gov ID
- NCT05585346
- Acronym / sponsor ID
- PBMT-IFP-2022
- Conditions
- Bell's Palsy
- Keywords
- Idiopathic facial paralysis, Bell's palsy, photobiomodulation, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 18 Oct 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.
Objective:
Bell's palsy is characterized by acute, unilateral onset that compromises function and esthetics, exerting a considerable impact on the social, professional, and psychological aspects of the lives of affected individuals. Without treatment, 30% of patients with complete paralysis will not completely recover. Therefore, shortening the recovery time will accelerate the recovery process leading to better results.
The objective of this study was to determine whether photobiomodulation therapy with laser acupuncture therapy could relieve symptoms in patients with Bell's palsy.
Methods:
This study was an open-label, randomized controlled trial including 96 patients that undergoing Bell's palsy. All the patients received oral vitamin B1.
Patients were assigned to the laser acupuncture (LA) group and control group, with 102 patients in each group. LA group were received 4 weeks of Laser treatment (3 times per week), while control group were received sham laser treatment.
Clinical outcome measure comprised the House-Brackmann grading system, Facial Clinimetric Evaluation Scale (FaCE), Sunnybrook facial grading scale (SBFG), and electrophysiological testing, including Electroneuronography (ENoG), Electromyography (EMG) and Blink Reflex. All the measurements were collected at the first day and at the end of study. All reported P values were two-sided and were declared statistically significant when less than 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser acupuncture Group | Experimental | Device: MLS laser, Drug: Oral vitamin B1LA group used a class IV Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy). MLS laser is a class IV NIR laser with two synchronized sources (905 nm with 75 W peak power, pulsed mode; 808 nm with power 1 W, continuous mode). Both laser beams were synchronized, the locked waves work with the range 1-2000 Hz. In LA group, based on clinical experience, we choose 5 acupoints on the affected side. It includes ST2(Si Bai), ST4(Di Cang), ST6(Jia Che), GB14(Yang Bai), GB20(Feng chi). We choose 7 acupoints, including LI4 (He Gu), LI11(Qu Chi), ST25 (Tian Shu), ST36 (Zu San Li), SP6 (San Yin Jiao), KI3 (Tai Xi), LR3 (Tai Chong). The acupoints in the limbs and trunk area, were applied bilaterally. Power of laser device is 50%. Oral vitamin B1. |
| Control Group | Active comparator | Device: MLS laser, Drug: Oral vitamin B1LA group used a class IV Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy). MLS laser is a class IV NIR laser with two synchronized sources (905 nm with 75 W peak power, pulsed mode; 808 nm with power 1 W, continuous mode). Both laser beams were synchronized, the locked waves work with the range 1-2000 Hz. In LA group, based on clinical experience, we choose 5 acupoints on the affected side. It includes ST2(Si Bai), ST4(Di Cang), ST6(Jia Che), GB14(Yang Bai), GB20(Feng chi). We choose 7 acupoints, including LI4 (He Gu), LI11(Qu Chi), ST25 (Tian Shu), ST36 (Zu San Li), SP6 (San Yin Jiao), KI3 (Tai Xi), LR3 (Tai Chong). The acupoints in the limbs and trunk area, were applied bilaterally. Power of laser device is 25%. Oral vitamin B1. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- (1) Clinical diagnosis of Bell's Palsy. (2) Adults over 18 years of age and under 60 years of age.
Key exclusion criteria (2 listed)
- (1) Systemic disease, such as severe diabetes, malignant tumors and other serious consumptive diseases.
- Serious mental illness or social problems, and neurological disorders. (3) Planning for pregnancy, in pregnancy or lactation.
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 |
|---|---|---|
| MLS laserTreatments were performed with MLS laser (Mphi laser, ASA Srl, Italy). MLS laser is a class IV NIR laser with two synchronized sources (laser diodes). The first one is a pulsed laser diode, emitting at 905 nm, with 25 W peak power. The second laser diode (808 nm) was operated in a continuous mode with power 1 W. Both of the laser beams were synchronized, the locked waves work within the range 1-2000 Hz. | Device | Control Group, Laser acupuncture Group |
| Oral vitamin B1Oral vitamin B1 10mg, times/day | Drug | Control Group, Laser acupuncture Group |
Primary outcome
The House-Brackmann Facial Nerve Grading System
Time frame: Change from Baseline number of pathological HB grading at 4-weeks in post-therapy.
The House-Brackmann facial nerve grading system (HB grading) is based on a 6-grade score that offers a gross evaluation of facial motor function and includes the evaluation of sequelae. The prognoses of patients with House-Brackmann grade I or grade II were considered good, and the prognoses of those with grade 3 or higher were considered poor.
The Sunnybrook Facial Grading System
Time frame: Change from Baseline scores of SB grading at at 4-weeks in post-therapy.
The Sunnybrook facial grading system (SB grading) is 13-items, self-reported questionnaire that used to evaluate the facial movement of patients. Among the overall 13 items of question, 3 items are resting symmetry, 5 items are symmetry of voluntary movement, and 5 items are synkinesis. Lower scores of Sunnybrook equate to greater severity of facial paralysis symptoms.
3 secondary outcomes
Electroneuronography (ENoG)
Time frame: Change from Baseline amplitude and potential of CAMP and the numbers of pathological ENoG at at 4-weeks in post-therapy.
Electromyography (EMG)
Time frame: Change from Baseline amplitude and duration of MUAPs at at 4-weeks in post-therapy.
Blink Reflex
Time frame: Change from Baseline number of pathological Blink Reflex at 6-months in post-therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MLS laser and Oral vitamin B1 in people with Bell's Palsy, run by Beijing Tongren Hospital at 1 site in China.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 24 Nov 2023. 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 China. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The House-Brackmann Facial Nerve Grading System (time frame: Change from Baseline number of pathological HB grading at 4-weeks in post-therapy.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2023.