Traumatic Facial ParalysisNCT06544603

Laser Acupuncture for Traumatic Facial Paralysis

An observational study of Traumatic Facial Paralysis, run by Beijing Tongren Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Objective: The objective of this study was to determine whether laser acupuncture therapy could relieve symptoms in patients with traumatic facial paralysis. Methods: This study was retrospective study including 174 patients that undergoing traumatic facial paralysis. All the patients received laser acupuncture (LA). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Traumatic Facial Paralysis
What is being tested?: Multiwave Locked System (MLS) laser
Type of treatment: Injection or infusion, Medical device
How many people: 174 participants
Where: 1 siteChina
Study dates: 1 Jan 2020to 10 Jul 2024
Phase: Observational
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

Study population: The study will enroll male and female participants aged 18-65 years, diagnosed with traumatic facial paralysis, with House-Brackmann grade (HB) 3 or higher. Exclusion criteria include serious mental illness or social problems, and neurological disorders, and systemic diseases, such as malignant tumors, and other serious consumptive diseases, planning for pregnancy, those in pregnancy, or those who were lactating, and neurotmesis by trauma. Participants will be recruited from outpatient clinics at Beijing Tongren Hospital through advertisements in the hospital and local community centers. All potential participants will undergo a thorough screening process, including a review of medical history and baseline tests, before providing written informed consent. Baseline characteristics will include age, gender, baseline HB, SB Grading, FaCE, ENoG, EMG and BR.

Who may be able to join

1, Patients diagnosed with traumatic facial paralysis 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. Neurotmesis by trauma.

Trial locations and contacts

1 site in 1 country.

China1 site

China Beijing TongRen Hospital, Capital Medical University Beijing, China
Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: Effect of Laser Acupuncture for Traumatic Facial Paralysis: A Retrospective Study

Objective:

The objective of this study was to determine whether laser acupuncture therapy could relieve symptoms in patients with traumatic facial paralysis.

Methods:

This study was retrospective study including 174 patients that undergoing traumatic facial paralysis. All the patients received laser acupuncture (LA).

Patients were assigned to the LA 1 month group, LA 3 month group and LA 6 month group, with 58 patients in each group.

Clinical outcome measure comprised the House-Brackmann grading system, Facial Clinimetric Evaluation Scale (FaCE), Sunnybrook facial grading scale (SBFG), Facial Disability Index (FDI), electroneuronography (ENoG), electromyography (EMG) and Blink reflex

Conditions: Traumatic Facial Paralysis
Being tested: Multiwave Locked System (MLS) laser
Keywords: traumatic facial paralysis, laser acupuncture, photobiomodulation, retrospective study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multiwave Locked System (MLS) laserDevice
Laser probe directly contacts with skin of the all the acupoints. The probe was fixed on each point for 1 min. In this study, the 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)

Study groups in NCT06544603
Study group	Role	What they receive
Control group		Not described
LA 3 month group		Laser acupuncture 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), ST25 (Tian Shu), 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), 1500 Hz, 50% power level, 50% duty cycle, 8.35 J/cm2 dosimetry, 26.22 J for each point, 36 times total treatment. Receives: Device: Multiwave Locked System (MLS) laser
LA 6 month group		Laser acupuncture 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), ST25 (Tian Shu), 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), 1500 Hz, 50% power level, 50% duty cycle, 8.35 J/cm2 dosimetry, 26.22 J for each point, 72 times total treatment. Receives: Device: Multiwave Locked System (MLS) laser

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, month 3, 6 and 12

Secondary outcomes (5)

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, month 3, 6 and 12
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, month 3, 6 and 12
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 and Orbicularis oris 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: Baseline, month 3, 6 and 12
Electromyography (EMG)
EMG is an electrophysiologic measures that indirectly quantify facial nerve function by recording motor unit action potentials (MUAPs) in the muscle of Frontalis muscle. 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: Baseline, month 3, 6 and 12
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: Baseline, month 3, 6 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202010 Jul 2024

First posted9 Aug 2024
Study start1 Jan 2020
Primary completion10 Jul 2024
Study completion10 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Traumatic Facial ParalysisStudies 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: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 174 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06544603
Sponsor's protocol ID: Laser-RS-2024
Status last verified: Jul 2024
First submitted: 6 Aug 2024
Last updated: 9 Aug 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Laser Acupuncture for Traumatic Facial Paralysis: A Retrospective Study
ClinicalTrials.gov ID: NCT06544603
Acronym / sponsor ID: Laser-RS-2024
Conditions: Traumatic Facial Paralysis
Keywords: traumatic facial paralysis, laser acupuncture, photobiomodulation, retrospective study
Study type: Observational
Recruitment status: Completed
Enrolment: 174 participants (actual)
Lead sponsor: Beijing Tongren HospitalUniversity, hospital or other
Study start: 1 Jan 2020 (actual)
Primary completion: 10 Jul 2024 (actual)
Study completion: 10 Jul 2024 (actual)
First posted: 9 Aug 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:

The objective of this study was to determine whether laser acupuncture therapy could relieve symptoms in patients with traumatic facial paralysis.

Methods:

This study was retrospective study including 174 patients that undergoing traumatic facial paralysis. All the patients received laser acupuncture (LA).

Patients were assigned to the LA 1 month group, LA 3 month group and LA 6 month group, with 58 patients in each group.

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 3

Arm	Type	Receives
Control group	–	–
LA 3 month group	–	Device: Multiwave Locked System (MLS) laserLaser acupuncture 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), ST25 (Tian Shu), 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), 1500 Hz, 50% power level, 50% duty cycle, 8.35 J/cm2 dosimetry, 26.22 J for each point, 36 times total treatment.
LA 6 month group	–	Device: Multiwave Locked System (MLS) laserLaser acupuncture 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), ST25 (Tian Shu), 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), 1500 Hz, 50% power level, 50% duty cycle, 8.35 J/cm2 dosimetry, 26.22 J for each point, 72 times total treatment.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study will enroll male and female participants aged 18-65 years, diagnosed with traumatic facial paralysis, with House-Brackmann grade (HB) 3 or higher. Exclusion criteria include serious mental illness or social problems, and neurological disorders, and systemic diseases, such as malignant tumors, and other serious consumptive diseases, planning for pregnancy, those in pregnancy, or those who were lactating, and neurotmesis by trauma. Participants will be recruited from outpatient clinics at Beijing Tongren Hospital through advertisements in the hospital and local community centers. All potential participants will undergo a thorough screening process, including a review of medical history and baseline tests, before providing written informed consent. Baseline characteristics will include age, gender, baseline HB, SB Grading, FaCE, ENoG, EMG and BR.

Key inclusion criteria (1 listed)

1, Patients diagnosed with traumatic facial paralysis 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. Neurotmesis by trauma.

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
Multiwave Locked System (MLS) laserLaser probe directly contacts with skin of the all the acupoints. The probe was fixed on each point for 1 min. In this study, the 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)	Device	LA 3 month group, LA 6 month group

Primary outcome

House Brackmann Grading System (HB)
Time frame: Baseline, month 3, 6 and 12
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.

5 secondary outcomes

Sunnybrook Facial Grading Scale (SB Grading)
Time frame: Baseline, month 3, 6 and 12
Facial Clinimetric Evaluation Scale (FaCE Scale)
Time frame: Baseline, month 3, 6 and 12
Electroneuronography (ENoG)
Time frame: Baseline, month 3, 6 and 12
Electromyography (EMG)
Time frame: Baseline, month 3, 6 and 12
Blink Reflex
Time frame: Baseline, month 3, 6 and 12

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 9 Aug 2024.

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?

An observational study of Traumatic Facial Paralysis, 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 9 Aug 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. 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?

House Brackmann Grading System (HB) (time frame: Baseline, month 3, 6 and 12). 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 NCT06544603.

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 9 Aug 2024.