Clinical Study on the End Time of Acupuncture and Moxibustion Therapy for Peripheral Facial Paralysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-02

Study Completion Date

2026-05-31

Brief Summary

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Bell's palsy itself has a certain self-healing tendency. Therefore, it is recommended to leave a bit of Bell's palsy for self-recovery without treatment. If complete recovery is achieved after treatment, complications such as stiffness, contracture and even hemifacial inversion may occur as time moves. Therefore, this study aims to evaluate the optimal end time of acupuncture for facial paralysis.

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Detailed Description

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This is a randomized, double-blind, controlled study, with a total of 120 eligible patients randomly divided into an observation group (n=60) and a control group (n=60). Both groups received facial acupuncture combined with infrared irradiation treatment, once a day,10 times as a course, and the next course of treatment will be carried out after a 5-day rest.The treatment duration for both groups will not exceed three months, with the observation group aiming for a Sunnybrook score of ≥83 and the control group aiming for a score≥95. The primary outcome measure is Sunnybrook scores at 6 months after onset compared with baseline. Secondary outcome measures included Sunnybrook Scores, electroneurography, blink reflex, Facial Disability Index, Self-Rating Depression Scale and Self-Rating Anxiety Scale.

Conditions

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Peripheral Facial Paralysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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observation group

Sunnybrook score ≥83 points

Group Type EXPERIMENTAL

acupuncture

Intervention Type OTHER

Acupuncture is applied to ST8, GB14, BL12, SJ23, ST2, SI18, ST4, ST7, RN24, Ex-HN16, SJ17 and LI4 on the affected side and needles are retained for half an hour.Add infrared irradiation therapy in the same time

control group

Sunnybrook score ≥95 points

Group Type ACTIVE_COMPARATOR

acupuncture

Intervention Type OTHER

Acupuncture is applied to ST8, GB14, BL12, SJ23, ST2, SI18, ST4, ST7, RN24, Ex-HN16, SJ17 and LI4 on the affected side and needles are retained for half an hour.Add infrared irradiation therapy in the same time

Interventions

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acupuncture

Acupuncture is applied to ST8, GB14, BL12, SJ23, ST2, SI18, ST4, ST7, RN24, Ex-HN16, SJ17 and LI4 on the affected side and needles are retained for half an hour.Add infrared irradiation therapy in the same time

Intervention Type OTHER

Other Intervention Names

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infrared irradiation therapy moxibustion

Eligibility Criteria

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Inclusion Criteria

1. Male or female patients aged 18-75 years.
2. Patients diagnosed with peripheral facial paralysis≤7 days before screening and was the first time.
3. All cases have symptoms and signs or have been examined by CT, MRI, etc., excluding peripheral facial paralysis caused by central nervous system diseases, ear diseases, and trauma.
4. Those who voluntarily sign the Research Informed Consent Form

Exclusion Criteria

1. Patients with bilateral facial nerve palsy or recurrent facial nerve palsy (more than two occurrences).
2. Pregnant or nursing patients.
3. Patients with critically ill which is difficult to make a definite evaluation of the efficacy and safety of treatment
4. Those who accept other treatment methods or cannot adhere to this plan, which affects the efficacy observation

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No