The purpose of this study is to explore the clinical efficacy of intradermal acupuncture in the treatment of ocular surface diseases after Intractable Facial Paralysis, and to seek effective and convenient treatment for ocular surface diseases after intractable peripheral facial paralysis. The main question it aims to answer is ： Will the intradermal acupuncture intervention effectively reduce the OSDI score ? The researchers compared the intradermal acupuncture with the placebo-needle to observe whether the intradermal acupuncture could better improve the symptoms.
Intractable Facial Paralysis(IFP) is often accompanied by ocular surface diseases(OSDs). This is because severe facial nerve injury and a prolonged recovery cycle occur in patients. Among these, incomplete eyelid closure, epiphora, and ocular motility disorders are the three most common conditions. These ocular surface problems may lead to exposure keratitis, conjunctivitis, and in severe cases, decreased visual acuity, which greatly affects daily work. In modern life, electronic products have become a necessity for work, study, and social interaction. Complete avoidance of electronic products is impossible for patients, which further aggravates ocular damage. At the same time, frequent use of electronic products leaves no time for damaged corneal epithelium to repair. This cumulative effect turns intermittent ocular surface damage into persistent damage. Currently, there are no clearly recommended therapeutic drugs for the recovery period of peripheral facial palsy in clinical guidelines. For accompanying OSDs, symptomatic and supportive treatments are commonly used clinically, such as sodium hyaluronate eye drops. However, due to long-term corneal exposure in these patients and frequent use of electronic products, artificial tears often fail to achieve ideal clinical efficacy. Therefore, exploring an "effective, safe, convenient, and sustainable" treatment method has important clinical value, which can solve long-term ocular problems during facial palsy in such patients. Existing studies have shown that intradermal acupuncture is effective for major depressive disorder, acute mountain sickness, pain and so on. But relatively few studies exist on its application in OSDs after IFP. To further verify the efficacy and safety of intradermal acupuncture therapy, a single-center, randomized, single-blinded, placebo-controlled parallel trial will be conducted. Through this study, a convenient, safe, and easily promotable therapeutic approach will be provided for OSDs after IFP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
78
The IA group will receive basic background treatment. During the intervention phase, the group will receive IA treatment. After basic background treatment, IA treatment will adopt acupoints. Under strict aseptic conditions, a φ0.20\*1.2 mm IA(SEIRIN Co.,Japan) will puncture perpendicularly and retained in the skin.It will be retained for 72 hours and replaced twice weekly, with the entire intervention course lasting 4 weeks. During the IA treatment period, participants will perform standardized self-administered pressing by a dedicated WeChat mini program: 3 times daily, 3 minutes per session, 60 presses per minute, stimulating as much as tolerated.
The SIA group will receive basic background treatment. During the intervention phase, the group will receive SIA treatment.
The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
Hangzhou, Zhejiang, China
RECRUITINGocular surface disease index
After 4 weeks of treatment, the proportion of patients with OSDI index score decreased by more than 12 points from baseline. According to previous studies, the minimal clinically important difference (MCID) for the Ocular Surface Disease Index (OSDI) was 10 points, and the MCID of the severe dry eye population was 7.3\~13.4 points. At the same time, based on the pre-test results of this study, 12 points corresponded to "significant improvement in patient perception" in this study. Therefore, the OSDI score decreased by ≥12 points from the baseline after 4 weeks of treatment, which was considered as "effective treatment".
Time frame: The treatment period was 4 weeks and the follow-up period was 6 weeks. During this period, assessments are conducted every 2 weeks.
tear meniscus height (TMH)
TMH：focuses on the tear meniscus at the lower eyelid margin via near-infrared mode, captures images below the pupil center, and calculates height through manual boundary calibration to assess baseline tear secretion.
Time frame: The treatment period was 4 weeks and the follow-up period was 6 weeks. During this period, the baseline, the 4th week, and the 10th week were evaluated.
Tear film break-up time (TBUT)
TBUT：uses non-invasive mode with near-infrared light and Prasy multi-disk projection; records the time from the last natural blink to the first corneal projection distortion (tear film break-up), with 3 repeated measurements averaged to evaluate tear film stability.
Time frame: The treatment period was 4 weeks and the follow-up period was 6 weeks. During this period, the baseline, the 4th week, and the 10th week were evaluated
Meibomian Gland Imaging
The patient is seated with the head stabilized in the headrest of a slit-lamp or dedicated meibography device. The patient is instructed to gently rotate the eyeball to fully expose the eyelid margin. The physician gently everts the upper and lower eyelids, activates the infrared imaging mode to capture meibomian gland images. The system automatically analyzes the meibomian gland loss area and completes the assessment for both eyes (OD/OS). The entire procedure is non-invasive, rapid, and causes no significant discomfort.
Time frame: The treatment period was 4 weeks and the follow-up period was 6 weeks. During this period, the baseline, the 4th week, and the 10th week were evaluated
The width of incomplete palpebral fissure closure
The width of incomplete palpebral fissure closure refers to the horizontal fissure distance left by the failure to fully fit the upper and lower eyelid margins when the eyelid is closed naturally or with maximum force. It is the core quantitative index for evaluating the eyelid closure function, usually in millimeters(mm).
Time frame: The treatment period was 4 weeks and the follow-up period was 6 weeks. During this period, assessments are conducted every 2 weeks.
Facial Nerve Grading System 2.0(FNGS 2.0)
The facial nerve grading system 2.0: is a standardized tool for quantifying the degree of facial nerve dysfunction. It is optimized by the H-B facial nerve grading scale and realizes the objective evaluation of facial nerve function through accurate sub-item scoring. It is a quantitative scoring system for facial nerve function commonly used in clinical and scientific research.
Time frame: The treatment period was 4 weeks and the follow-up period was 6 weeks. During this period, assessments are conducted every 2 weeks.
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