Clinical efficacy and safety of transcutaneous acupoint electrical stimulation combined with proton pump inhibitors in the treatment of laryngopharyngeal reflux disease

Phase 4

Recruiting

• Conditions: laryngopharyngeal reflux disease

• Registration Number: ITMCTR2100004891
• Lead Sponsor: The First Affiliated Hospital of Anhui Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Aged >= 18 years;
2. Symptoms of foreign body sensation in the throat for more than 6 weeks, continuous throat clearing, hoarseness, fatigue of pronunciation, sore throat, chronic cough, dyspnea and other symptoms;
3. Patients with RSI>13 points and/or RFS>7 points, Dx-ph monitoring diagnosed as acid reflux;
4. The patient signs an informed consent form and agrees to participate in the clinical trial.

Exclusion Criteria

1. The diagnosis is considered to be pharyngeal discomfort caused by bacterial or viral pharyngitis;
2. Upper gastrointestinal endoscopy or laryngoscopy found erosive gastroesophageal reflux, laryngeal cancer, esophageal cancer, gastric cancer and other diseases;
3. History of esophagus or stomach surgery, history of neck radiotherapy;
4. Severe liver, kidney and other organ dysfunction, unable to tolerate medications or allergic to medications;
5. Have used proton pump inhibitor therapy or other research drugs in the previous month;
6. Patients who are pregnant or breast-feeding;
7. RSI scale score (excluding the ninth item) <10 points;
8. Patients taking clopidogrel or warfarin;
9. Contraindications for transcutaneous electrical acupoint stimulation (TEAS): such as acupuncture points to stimulate skin rash or local infection or implantation of a pacemaker or defibrillator, electrode pads cause skin allergies or itching, etc. and patients suffering from acute diseases, infectious diseases, malignant tumors, cardiovascular and cerebrovascular diseases or other malignant diseases.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
visual analogue scale;reflux finding score;reflux symptom index;

Secondary Outcome Measures

Name	Time	Method
PR-HRQL scales;Dx-ph monitoring;