Acupuncture as an Adjunctive Therapy to Etoricoxib for Patients with Acute Gouty Arthritis: Protocol for a Multicenter Randomized Controlled Trial.

Abstract

Purpose: Acute gouty arthritis (AGA) is often managed with non-steroidal anti-inflammatory drugs. However, patients still tolerate severe pain before the analgesic takes effect. Early adjuvant analgesia is necessary in the pharmacological management of AGA. Acupuncture has the advantage of quick analgesia; nevertheless, the evidence to support the use of early-acupuncture as an adjunctive therapy for AGA is limited. This study aims to assess the efficacy of acupuncture compared with sham acupuncture on pain relief among AGA patients who are concurrently receiving etoricoxib.

Patients and methods: In this multicenter, randomized, controlled trial, total 160 eligible patients with AGA will be randomly allocated into acupuncture group and sham acupuncture group in a 1:1 ratio. All patients will receive oral etoricoxib followed by 30-minute acupuncture or sham acupuncture for 1 session. The primary outcome is the change in pain intensity (Visual Analogue Scale) after the 30-minute acupuncture treatment from baseline. The secondary outcomes include tenderness of study joint, swelling of study joint, rescue medicine, credibility and expectation evaluation and blinding assessment. Adverse events will be recorded during the trial. All the patients who are randomized in this study will be included in the intention-to-treat analysis.

Conclusion: The results of this study will provide evidence for acupuncture used in the treatment of acute gouty arthritis and promote clinical decisions to physicians and patients.

Trial registration: The protocol has been approved by the Medical Ethical Committee of Beijing University of Chinese Medicine (2023BZYLL0103) and registered at International Traditional Medicine Clinical Trial Registry (ITMCTR2024000218; http://itmctr.ccebtcm.org.cn/zh-CN/UserPlatform/ProjectView?pid=1749b951-b101-418f-8f82-77be3c72ea00).