Immediate Analgesic Effects of Cheek Acupuncture for Acute Gouty Arthritis

NCT ID: NCT06001112

Last Updated: 2024-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2023-12-31

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.

Conditions

Acute Gout Arthritis; Acupuncture; Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

acupuncture group

subjects will received cheek acupuncture for one time

Group Type: EXPERIMENTAL

cheek acupuncture

Intervention Type: OTHER

Based on the theory of holography and the theory of the Great Sanjiao, the acupoints were chosen under the guidance of the foundation of cheek acupuncture, selecting bilateral Sanjiao acupoints, bilateral head acupoints, foot and ankle acupoints on the affected side, and matching acupuncture points for local strengthening of the foot and ankle acupuncture points, using the triangular needle strengthening method. The treatment was performed with the patient lying on his back in a comfortable position, with routine local disinfection, rapid transdermal needle entry to the acupuncture points, and needle discharge after 30 minutes of needle retention, after which the needle hole was compressed with a cotton ball for a few moments.

etoricoxib

subjects will received etoricoxib 120mg for one time

Group Type: ACTIVE_COMPARATOR

Etoricoxib

Intervention Type: DRUG

etoricoxib 120mg

Interventions

cheek acupuncture

Based on the theory of holography and the theory of the Great Sanjiao, the acupoints were chosen under the guidance of the foundation of cheek acupuncture, selecting bilateral Sanjiao acupoints, bilateral head acupoints, foot and ankle acupoints on the affected side, and matching acupuncture points for local strengthening of the foot and ankle acupuncture points, using the triangular needle strengthening method. The treatment was performed with the patient lying on his back in a comfortable position, with routine local disinfection, rapid transdermal needle entry to the acupuncture points, and needle discharge after 30 minutes of needle retention, after which the needle hole was compressed with a cotton ball for a few moments.

Intervention Type: OTHER

Etoricoxib

etoricoxib 120mg

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Yuping Lin

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuping Lin, P.D.

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial Hospital of Traditional Chinese Medicine

Locations

Yupinglin Lin

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2021-06-clinical study

Identifier Type: -

Identifier Source: org_study_id