Clinical trial NCT06001112: Immediate Analgesic Effects of Cheek Acupuncture for Acute Gouty Arthritis
Official title: Immediate Analgesic Effects of Cheek Acupuncture for Acute Gouty Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Gout Arthritis
Acupuncture
Acute Pain
Keywords: Acute Gout Arthritis
acupuncture
Acute pain
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the immediate analgesic effect and patients' evaluation of the treatment of cheek acupuncture in patients with acute gouty arthritis. The main question it aims to answer are: Does cheek acupuncture has immediate pain relief effects on patients with acute gouty arthritis. Participants will received cheek acupuncture for 30 mins.

If there is a comparison group: Researchers will compare etoricoxib group to see if cheek acupuncture is superior to etoricoxib for improvement of acute pain in subjects with acute gouty arthritis.

Detailed description: The symptoms of acute gouty arthritis (AGA) are extremely painful, but most patients do not begin to experience pain relief until after they have been seen by a doctor and have taken their medication, leaving a time lag between the time they are seen and the time the treatment is effective. In clinical practice, researchers have found that the use of cheek acupuncture at the first visit to the patient often provides some immediate pain relief, but there is no evidence-based evidence for this.

This project was designed as a prospective, randomized, controlled clinical trial, in which patients with AGA who were seen for the first time were studied, and the treatment group was given cheek acupuncture and the control group was given oral etoricoxib tablets. VAS will be recorded before treatment, 0 min, 30 min, 1 h and 2 h after the start of treatment to depict the immediate analgesic efficacy curve and compare the immediate analgesic effect of the two groups at different time points. If the project is successfully completed, it will explore a treatment method for acute gouty arthritis that is fast-acting, painless and effective, eliminating the time lag between consultation and efficacy for the benefit of gout patients.

Eligibility criteria: Inclusion Criteria:

* Meet the diagnostic criteria for acute gouty arthritis and with attacks in the unilateral ankle or first metatarsophalangeal joint;

  * Age ≥18 years old and ≤75 years old, regardless of gender; ③ The gouty arthritis attack is within 48h; ④ Without therapy with targeted topical treatment or self-administered medications including colchicine, anti-inflammatory pain medications, hormones, herbs, etc.

Agreement to comply with the clinician's treatment plan.

Exclusion Criteria:

* Pregnant or breast-feeding

  * Patients with malignant tumors, severe dysfunction of the heart, liver, and kidneys, diabetes mellitus and hypertension

    * Mental disorders that render the patient unable to understand the nature of the study, its scope, and possible outcomes or unable to follow the doctor's advice

      * Allergic to the components of the drug in this study

        * Patients with active peptic ulcers/bleeding, or previous recurrent ulcers/bleeding.

          * History of asthma, urticaria or allergic reactions induced by taking aspirin or other non-steroidal anti-inflammatory drugs

            * Congestive heart failure (New York Heart Association \[NYHA\] cardiac function class II-IV)

Primary outcomes:
measure: Visual Analogue Scoring (VAS)
timeFrame: baseline, 0 minute, 30 minutes, 1 hour and 2 hours after the start of treatment
Secondary outcomes:
measure: Patient feedback score
timeFrame: 2 hours after the start of treatment
measure: Immediate pain relief
timeFrame: 2 hours after the start of treatment
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: Yupinglin Lin
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Yuping Lin, P.D.
role: PRINCIPAL_INVESTIGATOR
References: