Bell's PalsyNCT06280794
Efficacy of Laser Acupuncture for Idiopathic Bell's Palsy
A study testing Laser acupuncture and Steroids 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 65 years
- Conditions the study is for
- Bell's Palsy
- What is being tested?
- Laser acupuncture and Steroids
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 336 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 1 Feb 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients diagnosed with idiopathic Bell's Palsy 2.Patients were eligible if they were graded at House-Brackmann grade (HB) 3 or higher.
Who cannot join
- 1.Serious mental illness or social problems, and neurological disorders, and systemic diseases, such as malignant tumors, and other serious consumptive diseases.
- 2. Planning for pregnancy, those in pregnancy, or those who were lactating. 3.Bell's Palsy patients who have a disease course of more than 8 weeks.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing TongRen Hospital, Capital Medical University
Beijing
Dong Wu, Doctor, 8613810988682, wudong0120@outlook.com
Haihong Lian, Doctor, 8618811612190, lianhh123@163.com
About this study
Official title: Efficacy of Laser Acupuncture for Idiopathic Bell's Palsy: a Randomized Controlled Trial
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. The objective of this study was to determine whether laser acupuncture therapy could relieve symptoms in patients with Bell's palsy in 8 weeks.
Read more
Methods:
This study was randomized controlled trial including 360 patients that undergoing Bell's palsy. All the patients received oral Prednisolone. Patients were assigned to the laser acupuncture (LA) group, Sham LA group and control group, with 120 patients in each group. LA group and Sham LA group were received 4 weeks of Laser treatment (3 times per week).
Clinical outcome measure comprised the House-Brackmann grading system, Facial Clinimetric Evaluation Scale (FaCE), Sunnybrook facial grading scale (SBFG), Facial Disability Index (FDI) and Facial Clinimetric Evaluation Scale (FaCE Scale) All the measurements were collected at the baseline, weeks 2, 4, 6, 8, 12 and 24.
- Conditions
- Bell's Palsy
- Being tested
- Laser acupuncture, Steroids
- Keywords
- Idiopathic facial paralysis, Bell's palsy, Laser acupuncture, 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.
Laser acupunctureDevice
Patients in the laser acupuncture group (LA group) received 12 sessions of laser acupuncture (3 times per week). Laser aucpuncture used a class IV Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy).
In LA group, 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 6 acupoints, including LI4 (He Gu), LI11(Qu Chi), ST36 (Zu San Li), SP6 (San Yin Jiao), KI3 (Tai Xi), LR3 (Tai Chong).
Laser acupuncture used have wavelength of 808 nm and 905nm, 1.2 W power (808nm is 1 W, 905 nm is 200 mW), continuous mode emission (808 nm) and pulsed mode emission (905 nm), 500 Hz, 50% power level, 50% duty cycle, 8.35 J/cm2 dosimetry, 26.22 J for each point, administered for 3 times per week in the first 2 weeks, and 1500 Hz, 50% power level, 50% duty cycle, 8.35 J/cm2 dosimetry, 26.22 J for each point, in the last 2 weeks, 12 times total treatment.
SteroidsDrug
Prednisolone as 5 mg tablets (Tianjin Lisheng Pharmaceutical Co., Ltd., China) were given as a single dose of 30 mg daily for the first 3 days; 15 mg daily for the following 3 days; 10 mg daily for the after 3 days; 5 mg daily for the final 3 days, with a total treatment time of 9 days.
| Study group | Role | What they receive |
|---|---|---|
| Laser acupuncture Group | Experimental | Steroids. Patients in the laser acupuncture group (LA group) received 12 sessions of laser acupuncture (3 times per week). Laser aucpuncture used a class IV Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy).
In LA group, 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 6 acupoints, including LI4 (He Gu), LI11(Qu Chi), ST36 (Zu San Li), SP6 (San Yin Jiao), KI3 (Tai Xi), LR3 (Tai Chong).
Laser acupuncture used have wavelength of 808 nm and 905nm, 1.2 W power (808nm is 1 W, 905 nm is 200 mW), continuous mode emission (808 nm) and pulsed mode emission (905 nm), 500 Hz, 50% power level, 50% duty cycle, 8.35 J/cm2 dosimetry, 26.22 J for each point, administered for 3 times per week in the first 2 weeks, and 1500 Hz, 50% power level, 50% duty cycle, 8.35 J/cm2 dosimetry, 26.22 J for each point, in the last 2 weeks, 12 times total treatment. Receives: Device: Laser acupuncture; Drug: Steroids |
| Sham laser acupuncture Group | Sham comparator | Steroids. Patients in the laser acupuncture group (LA group) received 12 sessions of laser acupuncture (3 times per week). Laser aucpuncture used a class IV Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy).
In LA group, 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 6 acupoints, including LI4 (He Gu), LI11(Qu Chi), ST36 (Zu San Li), SP6 (San Yin Jiao), KI3 (Tai Xi), LR3 (Tai Chong).
The Sham LA group received the same laser device and the same acupoints. The device showed the same red light but did not emit a laser, administered for 3 times per week in the 4 weeks. Receives: Device: Laser acupuncture; Drug: Steroids |
| Control group | Other | Steroids. Receives: Drug: Steroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
House Brackmann Grading System (HB)
The HB is a physician-rated system based on criteria of resting appearance, facial movements, and synkinesis that categorizes facial function from I (normal) to VI (total paralysis), with options of "Normal", "Mild dysfunction", "Moderate dysfunction", "Moderately severe dysfunction", "Severe dysfunction" or "Total paralysis". The prognoses of grade 3 or higher were abnormal.
Measured: Baseline, weeks 2, 4, 6, 8, 12 and 24
Secondary outcomes (3)
Sunnybrook Facial Grading Scale (SB Grading)
The Sunnybrook Facial Grading Scale was used because of its international recognition and because it allowed a separate classification of the degree of synkinesis. The SB Grading is divided into three subscales of resting symmetry (Eye and Mouth range from 0 to 1, Cheek ranges from 0 to 2), symmetry of voluntary movement (ranges from 1 to 5), and synkinesis (ranges from 0 to 3). The three subscores are used to calculate a composite score (ranges from 0 to 100).
Measured: Baseline, weeks 2, 4, 6, 8, 12 and 24
Facial Disability Index (FDI)
Facial Disability Index (FDI) is a brief, self-report questionnaire of physical disability and psychosocial factors related to facial neuromuscular function. The FDI is a 10-item test that is divided into physical function (ranges from 0 to 5). and social/ well-being function (ranges from 1 to 6) domains. The physical function scores range from -25 (worst) to 100 (best), and the social/wellbeing function scores range from 0 (worst) to 100 (best).
Measured: Baseline, weeks 2, 4, 6, 8, 12 and 24
Facial Clinimetric Evaluation Scale (FaCE Scale)
FaCE is 15-items, self-reported questionnaire that used to assess facial impairment and disability after facial paralysis. It includes six independent domains: social function, facial movement, facial comfort, oral function, eye comfort, and lacrimal control. the total scores range from 0 (worst) to 100 (best).
Measured: Baseline, weeks 2, 4, 6, 8, 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Mar 2021
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280794
- Sponsor's protocol ID
- Laser-Bell-2024
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Laser Acupuncture for Idiopathic Bell's Palsy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06280794
- Acronym / sponsor ID
- Laser-Bell-2024
- Conditions
- Bell's Palsy
- Keywords
- Idiopathic facial paralysis, Bell's palsy, Laser acupuncture, photobiomodulation, RCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 28 Feb 2024 (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. The objective of this study was to determine whether laser acupuncture therapy could relieve symptoms in patients with Bell's palsy in 8 weeks.
Methods:
This study was randomized controlled trial including 360 patients that undergoing Bell's palsy. All the patients received oral Prednisolone. Patients were assigned to the laser acupuncture (LA) group, Sham LA group and control group, with 120 patients in each group. LA group and Sham LA group were received 4 weeks of Laser treatment (3 times per week).
Clinical outcome measure comprised the House-Brackmann grading system, Facial Clinimetric Evaluation Scale (FaCE), Sunnybrook facial grading scale (SBFG), Facial Disability Index (FDI) and Facial Clinimetric Evaluation Scale (FaCE Scale) All the measurements were collected at the baseline, weeks 2, 4, 6, 8, 12 and 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laser acupuncture Group | Experimental | Device: Laser acupuncture, Drug: SteroidsSteroids. Patients in the laser acupuncture group (LA group) received 12 sessions of laser acupuncture (3 times per week). Laser aucpuncture used a class IV Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy). In LA group, 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 6 acupoints, including LI4 (He Gu), LI11(Qu Chi), ST36 (Zu San Li), SP6 (San Yin Jiao), KI3 (Tai Xi), LR3 (Tai Chong). Laser acupuncture used have wavelength of 808 nm and 905nm, 1.2 W power (808nm is 1 W, 905 nm is 200 mW), continuous mode emission (808 nm) and pulsed mode emission (905 nm), 500 Hz, 50% power level, 50% duty cycle, 8.35 J/cm2 dosimetry, 26.22 J for each point, administered for 3 times per week in the first 2 weeks, and 1500 Hz, 50% power level, 50% duty cycle, 8.35 J/cm2 dosimetry, 26.22 J for each point, in the last 2 weeks, 12 times total treatment. |
| Sham laser acupuncture Group | Sham comparator | Device: Laser acupuncture, Drug: SteroidsSteroids. Patients in the laser acupuncture group (LA group) received 12 sessions of laser acupuncture (3 times per week). Laser aucpuncture used a class IV Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy). In LA group, 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 6 acupoints, including LI4 (He Gu), LI11(Qu Chi), ST36 (Zu San Li), SP6 (San Yin Jiao), KI3 (Tai Xi), LR3 (Tai Chong). The Sham LA group received the same laser device and the same acupoints. The device showed the same red light but did not emit a laser, administered for 3 times per week in the 4 weeks. |
| Control group | Other | Drug: SteroidsSteroids. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients diagnosed with idiopathic Bell's Palsy 2.Patients were eligible if they were graded at House-Brackmann grade (HB) 3 or higher.
Key exclusion criteria (2 listed)
- 1.Serious mental illness or social problems, and neurological disorders, and systemic diseases, such as malignant tumors, and other serious consumptive diseases.
- 2. Planning for pregnancy, those in pregnancy, or those who were lactating. 3.Bell's Palsy patients who have a disease course of more than 8 weeks.
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 |
|---|---|---|
| Laser acupuncturePatients in the laser acupuncture group (LA group) received 12 sessions of laser acupuncture (3 times per week). Laser aucpuncture used a class IV Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy). In LA group, 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 6 acupoints, including LI4 (He Gu), LI11(Qu Chi), ST36 (Zu San Li), SP6 (San Yin Jiao), KI3 (Tai Xi), LR3 (Tai Chong). Laser acupuncture used have wavelength of 808 nm and 905nm, 1.2 W power (808nm is 1 W, 905 nm is 200 mW), continuous mode emission (808 nm) and pulsed mode emission (905 nm), 500 Hz, 50% power level, 50% duty cycle, 8.35 J/cm2 dosimetry, 26.22 J for each point, administered for 3 times per week in the first 2 weeks, and 1500 Hz, 50% power level, 50% duty cycle, 8.35 J/cm2 dosimetry, 26.22 J for each point, in the last 2 weeks, 12 times total treatment. | Device | Laser acupuncture Group, Sham laser acupuncture Group |
| SteroidsPrednisolone as 5 mg tablets (Tianjin Lisheng Pharmaceutical Co., Ltd., China) were given as a single dose of 30 mg daily for the first 3 days; 15 mg daily for the following 3 days; 10 mg daily for the after 3 days; 5 mg daily for the final 3 days, with a total treatment time of 9 days. | Drug | Control group, Laser acupuncture Group, Sham laser acupuncture Group |
Primary outcome
House Brackmann Grading System (HB)
Time frame: Baseline, weeks 2, 4, 6, 8, 12 and 24
The HB is a physician-rated system based on criteria of resting appearance, facial movements, and synkinesis that categorizes facial function from I (normal) to VI (total paralysis), with options of "Normal", "Mild dysfunction", "Moderate dysfunction", "Moderately severe dysfunction", "Severe dysfunction" or "Total paralysis". The prognoses of grade 3 or higher were abnormal.
3 secondary outcomes
Sunnybrook Facial Grading Scale (SB Grading)
Time frame: Baseline, weeks 2, 4, 6, 8, 12 and 24
Facial Disability Index (FDI)
Time frame: Baseline, weeks 2, 4, 6, 8, 12 and 24
Facial Clinimetric Evaluation Scale (FaCE Scale)
Time frame: Baseline, weeks 2, 4, 6, 8, 12 and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: Yes
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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.
Beijing TongRen Hospital, Capital Medical University
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser acupuncture and Steroids 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: status not confirmed, as of the sponsor's last update on 25 Nov 2024. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
House Brackmann Grading System (HB) (time frame: Baseline, weeks 2, 4, 6, 8, 12 and 24). 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 25 Nov 2024.