Clinical trial NCT06544603: Laser Acupuncture for Traumatic Facial Paralysis
Official title: Effect of Laser Acupuncture for Traumatic Facial Paralysis: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Facial Paralysis
Keywords: traumatic facial paralysis
laser acupuncture
photobiomodulation
retrospective study
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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).

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


Eligibility criteria: Inclusion Criteria:

* 1, Patients diagnosed with traumatic facial paralysis 2, Patients were eligible if they were graded at House-Brackmann grade (HB) 3 or higher.

Exclusion Criteria:

- 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.

Primary outcomes:
measure: House Brackmann Grading System (HB)
timeFrame: Baseline, month 3, 6 and 12
Secondary outcomes:
measure: Sunnybrook Facial Grading Scale (SB Grading)
timeFrame: Baseline, month 3, 6 and 12
measure: Facial Clinimetric Evaluation Scale (FaCE Scale)
timeFrame: Baseline, month 3, 6 and 12
measure: Electroneuronography (ENoG)
timeFrame: Baseline, month 3, 6 and 12
measure: Electromyography (EMG)
timeFrame: Baseline, month 3, 6 and 12
measure: Blink Reflex
timeFrame: Baseline, month 3, 6 and 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: China Beijing TongRen Hospital, Capital Medical University Beijing, China
state: Beijing
Study officials:
References: