Facial Paralysis, PeripheralNCT07537426
The Efficacy of Intradermal Acupuncture for Ocular Surface Diseases After Intractable Facial Paralysis
A study testing Intradermal acupuncture treatment in people with Facial Paralysis, Peripheral and Bell's Palsy, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Facial Paralysis, Peripheral, Bell's Palsy, Ocular Surface Disease
- What is being tested?
- Intradermal acupuncture treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 25 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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.Male or female patients aged 18-65 years.
- 2.Meets diagnostic criteria for intractable peripheral facial paralysis, with disease duration from 1 month to 1 year. FNGS 2.0 ≥15 points; ENoG shows the ratio of CMAP amplitude≤ 20%.
- 3.At least one subjective ocular symptom (dryness, foreign body sensation, burning, fatigue, redness, fluctuating vision) and OSDI scores between 30 and 80.
- 4.Voluntarily provides written informed consent and can comply with treatment and follow-up.
Who cannot join
- 1.Other ocular diseases (glaucoma, keratitis, retinopathy, acute inflammation of conjunctiva, sclera, cornea).
- 2. Intraocular surgery or laser therapy within the past 90 days.
- 3.Use of systemic or topical antibiotics or tear-affecting drugs within 3 weeks; dry eye medications within 2 weeks.
- 4.Lacrimal passage obstruction, dacryocystitis, punctal occlusion, or neurological impairment preventing full eyelid closure.
- 5.Coagulation disorders, open wounds, or local infection at intervention sites.
- 6.Allergy to press-needle materials (stainless steel, adhesive tape).
Show all 9Show fewer
- 7.Pregnancy or lactation.
- 8.Severe cardiac, hepatic, renal, psychiatric disorders, or malignant tumors.
- 9.Participation in another clinical trial within the past month.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
Hangzhou, Zhejiang, 310000
The First Affiliated Hospital of Zhejiang University of Tradit The First Affiliated Hospital of Zhejiang University of Tradit, 13758271294, 20103034@zcmu.edu.cn
About this study
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.
Read the detailed description
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.
- Being tested
- Intradermal acupuncture treatment, Sham intradermal acupuncture
- Keywords
- sequelae of facial paralysis, ocular surface disease, intradermal acupuncture
- Medical subject headings
- Facial Paralysis, Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradermal acupuncture treatmentOther
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.
Sham intradermal acupunctureOther
The SIA group will receive basic background treatment. During the intervention phase, the group will receive SIA treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intradermal Acupuncture group(IA group) | Experimental | basic background treatment + IA treatment Receives: Other: Intradermal acupuncture treatment |
| Sham Intradermal Acupuncture group(SIA group) | Placebo comparator | basic background treatment + SIA treatment Receives: Other: Sham intradermal acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
ocular 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".
Measured: The treatment period was 4 weeks and the follow-up period was 6 weeks. During this period, assessments are conducted every 2 weeks.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: The treatment period was 4 weeks and the follow-up period was 6 weeks. During this period, assessments are conducted every 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Apr 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion25 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Facial Paralysis, PeripheralStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537426
- Sponsor's protocol ID
- 2026-KLS-167-01
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yao J, Cen L, Li Q, Liu S, Zhu C, Xuan L, Yu B. Efficacy of intradermal acupuncture for ocular surface diseases secondary to refractory peripheral facial palsy: a randomized controlled trial study protocol. Front Med (Lausanne). 2026 Jul 20;13:1873689. doi: 10.3389/fmed.2026.1873689. eCollection 2026.
PubMed 42549110
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Intradermal Acupuncture for Ocular Surface Diseases After Intractable Facial Paralysis
- ClinicalTrials.gov ID
- NCT07537426
- Acronym / sponsor ID
- 2026-KLS-167-01
- Keywords
- sequelae of facial paralysis, ocular surface disease, intradermal acupuncture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 25 Mar 2028 (estimated)
- First posted
- 17 Apr 2026 (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.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intradermal Acupuncture group(IA group) | Experimental | Other: Intradermal acupuncture treatmentbasic background treatment + IA treatment |
| Sham Intradermal Acupuncture group(SIA group) | Placebo comparator | Other: Sham intradermal acupuncturebasic background treatment + SIA treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1.Male or female patients aged 18-65 years.
- 2.Meets diagnostic criteria for intractable peripheral facial paralysis, with disease duration from 1 month to 1 year. FNGS 2.0 ≥15 points; ENoG shows the ratio of CMAP amplitude≤ 20%.
- 3.At least one subjective ocular symptom (dryness, foreign body sensation, burning, fatigue, redness, fluctuating vision) and OSDI scores between 30 and 80.
- 4.Voluntarily provides written informed consent and can comply with treatment and follow-up.
Key exclusion criteria (9 listed)
- 1.Other ocular diseases (glaucoma, keratitis, retinopathy, acute inflammation of conjunctiva, sclera, cornea).
- 2. Intraocular surgery or laser therapy within the past 90 days.
- 3.Use of systemic or topical antibiotics or tear-affecting drugs within 3 weeks; dry eye medications within 2 weeks.
- 4.Lacrimal passage obstruction, dacryocystitis, punctal occlusion, or neurological impairment preventing full eyelid closure.
- 5.Coagulation disorders, open wounds, or local infection at intervention sites.
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 |
|---|---|---|
| Intradermal acupuncture treatmentThe 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. | Other | Intradermal Acupuncture group(IA group) |
| Sham intradermal acupunctureThe SIA group will receive basic background treatment. During the intervention phase, the group will receive SIA treatment. | Other | Sham Intradermal Acupuncture group(SIA group) |
Primary outcome
ocular surface disease index
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.
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".
5 secondary outcomes
tear meniscus height (TMH)
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)
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
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
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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Derived from this study: PubMed 42549110Yao J, Cen L, Li Q, Liu S, Zhu C, Xuan L, Yu B. Efficacy of intradermal acupuncture for ocular surface diseases secondary to refractory peripheral facial palsy: a randomized controlled trial study protocol. Front Med (Lausanne). 2026 Jul 20;13:1873689. doi: 10.3389/fmed.2026.1873689. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradermal acupuncture treatment in people with Facial Paralysis, Peripheral and Bell's Palsy, run by The First Affiliated Hospital of Zhejiang Chinese Medical University 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 17 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Binyan Yu Binyan Yu (13758271294, 20103034@zcmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ocular surface disease index (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.). 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 NCT07537426, which also lists 1 linked publication.
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 17 Apr 2026.