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Immediate Analgesic Effects of Cheek Acupuncture for Acute Gouty Arthritis (CAAGA)

Primary Purpose

Acute Gout Arthritis, Acupuncture, Acute Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cheek acupuncture
Etoricoxib
Sponsored by
Guangdong Provincial Hospital of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Gout Arthritis focused on measuring Acute Gout Arthritis, acupuncture, Acute pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    acupuncture group

    etoricoxib

    Arm Description

    subjects will received cheek acupuncture for one time

    subjects will received etoricoxib 120mg for one time

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Patient feedback score
    an 8-point patient global assessent of treatment response score was used
    Immediate pain relief
    After the efficacy evaluation of the pain index by retesting 2 hours after the first treatment, the degree of pain relief was divided into: immediate efficacy, which means that all the pain was relieved; apparent efficacy, which means that the pain symptoms were significantly relieved; improvement, which means that the pain situation was relieved; and ineffectiveness, which means that the pain was not resolved at all. Immediate apparent efficiency = immediate efficiency + apparent efficiency.

    Full Information

    First Posted
    August 8, 2023
    Last Updated
    August 18, 2023
    Sponsor
    Guangdong Provincial Hospital of Traditional Chinese Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06001112
    Brief Title
    Immediate Analgesic Effects of Cheek Acupuncture for Acute Gouty Arthritis
    Acronym
    CAAGA
    Official Title
    Immediate Analgesic Effects of Cheek Acupuncture for Acute Gouty Arthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Guangdong Provincial Hospital of Traditional Chinese Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Gout Arthritis, Acupuncture, Acute Pain
    Keywords
    Acute Gout Arthritis, acupuncture, Acute pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    76 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    acupuncture group
    Arm Type
    Experimental
    Arm Description
    subjects will received cheek acupuncture for one time
    Arm Title
    etoricoxib
    Arm Type
    Active Comparator
    Arm Description
    subjects will received etoricoxib 120mg for one time
    Intervention Type
    Other
    Intervention Name(s)
    cheek acupuncture
    Intervention Description
    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
    Drug
    Intervention Name(s)
    Etoricoxib
    Intervention Description
    etoricoxib 120mg
    Primary Outcome Measure Information:
    Title
    Visual Analogue Scoring (VAS)
    Description
    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.
    Time Frame
    baseline, 0 minute, 30 minutes, 1 hour and 2 hours after the start of treatment
    Secondary Outcome Measure Information:
    Title
    Patient feedback score
    Description
    an 8-point patient global assessent of treatment response score was used
    Time Frame
    2 hours after the start of treatment
    Title
    Immediate pain relief
    Description
    After the efficacy evaluation of the pain index by retesting 2 hours after the first treatment, the degree of pain relief was divided into: immediate efficacy, which means that all the pain was relieved; apparent efficacy, which means that the pain symptoms were significantly relieved; improvement, which means that the pain situation was relieved; and ineffectiveness, which means that the pain was not resolved at all. Immediate apparent efficiency = immediate efficiency + apparent efficiency.
    Time Frame
    2 hours after the start of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yuping Lin, P.D.
    Phone
    +86 13570459624
    Email
    yupinglin@gzucm.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yuping Lin, P.D.
    Organizational Affiliation
    Guangdong Provincial Hospital of Traditional Chinese Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    request from the author
    IPD Sharing Time Frame
    3year after the end of the trial

    Learn more about this trial

    Immediate Analgesic Effects of Cheek Acupuncture for Acute Gouty Arthritis

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