Trial of transcutaneous electrical acupoint stimulation in laryngopharyngeal reflux disease: study protocol for a randomized controlled trial.

Abstract

BACKGROUND:

Patients with persistent globus sensation, throat clearing, chronic cough, hoarseness, and other throat symptoms account for a large proportion of patients in ears, nose, and throat clinics. Laryngopharyngeal reflux disease (LPRD) is increasingly valued by otolaryngologists. Transcutaneous electrical acupoint stimulation (TEAS) is possibly a new method for the treatment of LPRD. This trial aims to determine whether TEAS combined with proton pump inhibitor (PPI) is better than PPI alone in the treatment of LPRD.

METHODS:

This prospective randomized controlled trial will be implemented in a tertiary hospital in China. Seventy patients diagnosed with LPRD will be randomly assigned to the TEAS + PPI group (intervention group) or PPI group (control group), at a ratio of 1:1. In addition to using PPI, the intervention group will receive TEAS at four groups of acupoints, and each group will be treated for 15 min, once for 60 min, five times a week, for 12 weeks, 60 times. The main outcome will be changes in the Reflux Symptom Index scores at 4, 12, and 24 weeks after treatment. The secondary outcomes will include changes in the reflux finding score, Laryngopharyngeal Reflux-Health-related Quality of Life score, and throat pain visual analog scale score.

DISCUSSION:

This trial will explore the feasibility of TEAS combined with PPI for the treatment of LPRD and provide potential evidence for its effectiveness and safety. The results of this study will be published in a peer-reviewed journal.

TRIAL REGISTRATION:

Chinese Clinical Trial Registry ChiCTR2100046755 . Registered on May 28, 2021.

• Authors: Hailong Shen, Yanxun Han, Di Wu, Lihong Hu, Yunxia Ma, Feihu Wu, Ye Tao, Yehai Liu
• Journal: Trials (Trials) Vol. 23 Issue 1 Pg. 272 (Apr 08 2022) ISSN: 1745-6215 [Electronic] England
• PMID: 35395946 (Publication Type: Clinical Trial Protocol, Journal Article)
• Copyright: © 2022. The Author(s).

Chemical References

• Proton Pump Inhibitors

Topics

• Acupuncture Points
• Humans
• Laryngopharyngeal Reflux (drug therapy, therapy)
• Prospective Studies
• Proton Pump Inhibitors (adverse effects)
• Quality of Life
• Randomized Controlled Trials as Topic
• Transcutaneous Electric Nerve Stimulation (adverse effects, methods)
• Treatment Outcome