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. 2018 Jun 11;19(1):316.
doi: 10.1186/s13063-018-2699-z.

Augmentation effect of acupuncture on Bi'nao for hypophasis in patients with Bell's palsy: study protocol for a randomized controlled trial

Xiaoyan Li  1   2 , Chunlan Chen  1   2 , Chuang Zhao  1   2 , Zunyuan Li  1   2 , Wei Liang  1   2 , Zhidan Liu  3   4
Affiliations

Augmentation effect of acupuncture on Bi'nao for hypophasis in patients with Bell's palsy: study protocol for a randomized controlled trial

Xiaoyan Li et al. Trials. .

Abstract

Background: Hypophasis is one of the most frequently observed sequelae of patients with Bell's palsy, who have not recovered completely, creating a clinical difficulty for physicians. Acupuncture therapy has been widely used to treat Bell's palsy as a reasonable resolution for management of symptoms such as hypophasis. The number of acupuncture points (acu-points) is frequently selected in the approach of acupuncture therapy; however, whether these had high efficiency has not been proved. According to the literature review, Bi'nao was useful for treating eye and eye lipid diseases, which could be proved only by some successful cases. Thus, a randomized controlled trial was designed to evaluate the efficiency of the acu-point Bi'nao.

Methods/design: Participants with hypophasis as the major symptom are selected among patients with Bell's palsy and randomly allocated into one of the three groups at a 1:1:1 allocation ratio. All participants receive conventional acupuncture therapy; however, those assigned to the real acupuncture group will be given added acupuncture therapy on the acu-point Bi'nao, while those assigned to the sham acupuncture group were given extra acupuncture therapy on the sham Bi'nao as a placebo. The efficacy of the acupuncture therapy on the acu-point Bi'nao for hypophasis will be evaluated by Eye Crack Width Measurement (ECWM) and Eyelid Strength Assessment (ESA) before and after therapy.

Discussion: This is the first study assessing the safety and efficiency of Bi'nao in treating the hypophasis of patients with Bell's palsy that might support the application of this acupuncture therapy. However, evaluating hypophasis is challenging, and, thus, ECWM and ESA were applied to measure the eyelid movement.

Trial registration: Chinese Clinical Trials Registry, ChiCTR-INR-17012955 . Registered on 12 October 2017.

Keywords: Acupuncture; Bell’s palsy; Facial paralysis; Hypophasis.

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Conflict of interest statement

Ethics approval and consent to participate

This study was approved by the institutional review board (IRB) of Medical Ethics Committee Board of Baoshan Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Shanghai (201709–02). Written consent will be collected by research assistants from the participants potentially eligible for the study.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Schematic representation of the study design
Fig. 2
Fig. 2
The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Figure. The schedule of enrollment, allocation, interventions, and assessments. ECWM Eye Crack Width Measurement, ESA Eyelid Strength Assessment
Fig. 3
Fig. 3
Location of acupoints. BL2, Cuanzhu, on the medial end of the eyebrow; GB14, Yangbai, directly above the pupil, 1 cun above the midpoint of the eyebrow; Shangming, in the orbital cavity and at the midpoint of the orbital margin; SJ23, Sizhukong, in the depression at the lateral end of the eyebrow; LI14, Bi’nao, at the stop of deltoid muscle on the line between LI15 (Jianyu) and Quchi (LI11), 7 cun above Quchi (LI11); Sham LI14, 1 cm backward to Bi’nao; SJ5, Waiguan, on the line joining Yangchi (SJ4) and the tip of elbow, 2 cun above the dorsocarpal transverse crease between the ulna and radius; KI6, Zhaohai, in the depression directly below the tip of the medial malleolus
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