Electroacupuncture for Mild-to-moderate Dry Eye

NCT ID: NCT05552820

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-12
• Study Completion Date: 2026-08-31

Brief Summary

To determine if electroacupuncture acts as an dry eye treatment rather than a placebo, and identify if benefits are linked to corneal subbasal nerve changes and neuroimmunomodulatory indicators.

Detailed Description

Acupuncture is an important method in the treatment of diseases in Chinese medicine and plays an important role in the treatment of many diseases. Electroacupuncture (EA), as a combination of acupuncture and electric stimulation, is now widely used in research and clinical treatment. Our preliminary study found that compared with 0.1% sodium hyaluronate eye drops, EA exerted more beneficial and durable effects after four weeks of treatment. However, the placebo effect of EA cannot be ruled out yet. The aim of this study is to determine if EA acts as an dry eye treatment rather than a placebo, and identify if benefits are linked to corneal subbasal nerve changes.

This is a multicenter, randomized, subject-blinded, sham-controlled trial. A total of 168 participants with mild-to-moderate dry eye will be randomly assigned (1:1) to verum EA or non-penetrating non-acupoint sham EA (3 times weekly for 4 weeks), followed by a 24-week follow-up. The primary efficacy outcome is the change from baseline to week 4 in the Noninvasive Tear Breakup Time (NIBUT). Secondary efficacy outcomes include tear meniscus height (TMH), Schirmer I test (SⅠT), corneal topography, corneal and conjunctival sensation, scores of Ocular Surface Disease Index (OSDI), corneal fluorescein staining (CFS), Numerical rating scale (NRS), and Chinese Dry Eye Related Quality of Life Scale (CDERQOL) . Additionally, we will apply the Patient Health Questionnaire-9 (PHQ-9) and the Generalized Anxiety Disorder (GAD-7) to understand the mental health conditions of patients. IVCM will be performed to observe the morphological changes of the corneal basal nerve. The changes of NGF, CGRP, NPY, 8-OHDG, 4-HNE, MDA and other neuroimmunomodulatory indicators in tears and conjunctival cells will be detected by immunofluorescence, ELISA, or other techniques.

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Verum Electroacupuncture

Verum electroacupuncture treatment will be given 3 times a week, at least 1 day apart , for consecutive 4 weeks with a 24-week follow-up. Each session lasts for 30 min.

Group Type: EXPERIMENTAL

Verum Electroacupuncture

Intervention Type: DEVICE

Acupoints: Cuanzhu (BL2), Taiyang (EX-HN5), Sibai (ST1), Sizhukong (TE23), Baihui (GV20), Fengchi (GB20), Hegu (LI4), Zusanli (ST36), Guangming (GB23), Sanyinjiao (SP6), and Taichong (LR3). All acupoints will be taken bilaterally, except Baihui (GV20). The subject is placed in the supine position with eyes close. After routine sterilization, the sterile polyethylene cylindrical needle pad will be adhered to the acupoints. Then, the sterile acupuncture needles (0.25 mm×0.40 mm, Hwato brand, China.) will be inserted into the skin through the needle pad. Twirling and lifting-thrusting manipulations will be performed on the acupoints until Deqi is reported by the subject. Two pairs of electrodes will be connected at the needle handles on BL2 and EX-HN5 with a 2 Hz, continuous-wave electro-stimulation provided by the electroacupuncture apparatus (SDZ-Ⅲ type, Hwato brand, China). The pulse amplitude is about 1-2 mA.

Sham Electroacupuncture

Sham electroacupuncture on non-acupoints plus non-penetrating plus no electrical stimulation will be given 3 times a week, at least 1 day apart , for consecutive 4 weeks with a 24-week follow-up. Each session lasts for 30 min.

Group Type: SHAM_COMPARATOR

Sham Electroacupuncture

Intervention Type: DEVICE

Sham acupoints: SA1(1 cm above BL2), SA2 (1 cm above SJ23)，SA3 (1 cm above EX-HN5), SA4 (1 cm lateral to ST2), SA5 (the midpoint of the line between GV20 and right EX-HN1), SA6 (the midpoint of the line between GB20 and SJ16), SA7 (1 cm lateral to LI4), SA8 (the midpoint of the line between ST36 and GB34), SA9 (the midpoint of the line between GB37 and BL58), SA10 (1 cm backward to SP6), SA11 (the midpoint of the line between LR3 and SP4). After routine sterilization, placebo needles will be used (Streitberger, Asia-med GmbH). The tingling sensation produced when the Streitberger needle is fixed on the skin causes the subject to believe that the needle is piercing the skin, simulating a skin puncture. The electric stimulator is applied to bilateral SA1 and SA3 with no current output. The exterior appearance, indicator light, prompt tone of the sham device, and stimulation parameters are all indistinguishable from the normal one.

Interventions

Verum Electroacupuncture

Acupoints: Cuanzhu (BL2), Taiyang (EX-HN5), Sibai (ST1), Sizhukong (TE23), Baihui (GV20), Fengchi (GB20), Hegu (LI4), Zusanli (ST36), Guangming (GB23), Sanyinjiao (SP6), and Taichong (LR3). All acupoints will be taken bilaterally, except Baihui (GV20). The subject is placed in the supine position with eyes close. After routine sterilization, the sterile polyethylene cylindrical needle pad will be adhered to the acupoints. Then, the sterile acupuncture needles (0.25 mm×0.40 mm, Hwato brand, China.) will be inserted into the skin through the needle pad. Twirling and lifting-thrusting manipulations will be performed on the acupoints until Deqi is reported by the subject. Two pairs of electrodes will be connected at the needle handles on BL2 and EX-HN5 with a 2 Hz, continuous-wave electro-stimulation provided by the electroacupuncture apparatus (SDZ-Ⅲ type, Hwato brand, China). The pulse amplitude is about 1-2 mA.

Intervention Type: DEVICE

Sham Electroacupuncture

Sham acupoints: SA1(1 cm above BL2), SA2 (1 cm above SJ23)，SA3 (1 cm above EX-HN5), SA4 (1 cm lateral to ST2), SA5 (the midpoint of the line between GV20 and right EX-HN1), SA6 (the midpoint of the line between GB20 and SJ16), SA7 (1 cm lateral to LI4), SA8 (the midpoint of the line between ST36 and GB34), SA9 (the midpoint of the line between GB37 and BL58), SA10 (1 cm backward to SP6), SA11 (the midpoint of the line between LR3 and SP4). After routine sterilization, placebo needles will be used (Streitberger, Asia-med GmbH). The tingling sensation produced when the Streitberger needle is fixed on the skin causes the subject to believe that the needle is piercing the skin, simulating a skin puncture. The electric stimulator is applied to bilateral SA1 and SA3 with no current output. The exterior appearance, indicator light, prompt tone of the sham device, and stimulation parameters are all indistinguishable from the normal one.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients meeting the diagnostic criteria for dry eye according to the TFOS DEWS Ⅱ
• Ages 18-65 years, no gender limit

Exclusion Criteria

• Diagnosed with severe dry eye
• Combined with other eye diseases (e.g. severe blepharitis, blepharospasm, conjunctival laxity, strabismus, amblyopia, glaucoma, cataract, fundus disease, ocular trauma)
• With active eye diseases or a history of eye surgery within 3 months
• Received acupuncture treatment or other dry eye treatment measures within 1 month that may influence the assessment of efficacy
• Previously experienced electroacupuncture intervention
• Pregnant or breastfeeding females
• Serious systemic diseases such as cardiovascular, cerebrovascular, hepatic, renal, and hematopoietic system and psychiatric disorders
• With autoimmune diseases such as Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, or ankylosing spondylitis
• With damaged, ulcerated, infected, or scarred skin at the selected acupoints
• Allergic to metal or tape

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role: collaborator

Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role: collaborator

Shanghai Institute of Acupuncture, Moxibustion and Meridian

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaopeng Ma, MD, PhD

Role: STUDY_CHAIR

Shanghai University of Traditional Chinese Medicine

Locations

Guang Yang

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Guang Yang, MD

Role: CONTACT

sunnyyang0415@163.com

+8618817818512

Facility Contacts

Yang Guang, MD

Role: primary

sunnyyang0415@163.com

+8618817818512

References

Lu YQ, Yang G, Li MY, Hong J, Yang YT, Wang XJ, Kong XH, Zhao Y, Ma Z, Huang XY, Zou YL, Zhou XT, Ma XP. Electroacupuncture for mild-to-moderate dry eye: study protocol for a multicentre, randomised, single-blind, sham-controlled trial. BMJ Open. 2023 Dec 6;13(12):e069369. doi: 10.1136/bmjopen-2022-069369.

Reference Type: DERIVED

PMID: 38056935 (View on PubMed)

Other Identifiers

ShanghaiIAMM20220918

Identifier Type: -

Identifier Source: org_study_id