Immediate Analgesic Effects of Cheek Acupuncture for Acute Gouty Arthritis

NCT06001112 | Completed DMC

• 1 other identifier: 2021-06-clinical study
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Gout Arthritis; Acupuncture; Acute Pain

Keywords

Acute Gout Arthritis; acupuncture; Acute pain

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scoring (VAS)

  a 10 cm long horizontal or vertical line that divides the pain level into 10 levels (i.e., 1 level for every 1 cm), with the leftmost (or upper) end representing "no pain" and the rightmost (or lower) end representing "severe pain The leftmost (or upper) end represents "no pain" and the rightmost (or lower) end represents "severe pain", and the patient is asked to mark the pain level he/she feels with an "I" on this line.

  baseline, 0 minute, 30 minutes, 1 hour and 2 hours after the start of treatment

Secondary Outcomes (2)

• Patient feedback score

  2 hours after the start of treatment

• Immediate pain relief

  2 hours after the start of treatment

Study Arms (2)

acupuncture group

EXPERIMENTAL

subjects will received cheek acupuncture for one time

Other: cheek acupuncture

etoricoxib

ACTIVE COMPARATOR

subjects will received etoricoxib 120mg for one time

Drug: Etoricoxib

Interventions

cheek acupuncture 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.

acupuncture group

Etoricoxib DRUG

etoricoxib 120mg

etoricoxib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Yupinglin Lin

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yuping Lin, P.D.

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 21, 2023
• Study Start: September 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 3year after the end of the trial

Locations

CN (1)