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Clinical study of wearable low-intensity ultrasound (LIUS) in the treatment of patients with gouty arthritis (GA)

Clinical study of wearable low-intensity ultrasound (LIUS) in the treatment of patients with gouty arthritis (GA)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077713
Enrollment
Unknown
Registered
2023-11-16
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gouty arthritis

Interventions

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) ages between 18 and 80 years; 2) in accordance with the preliminary criteria for the classification of primary gout acute arthritis of the American Rheumatic Association, it was diagnosed as primary gout; 3) A history of more than once acute gout attack in the past 12 months; 4) in the 0-10 pain digital evaluation scale (numericalratingscale), the acute pain with baseline pain intensity = 5 points lasted for less than 5 days; 5) patients with stable pain in the past 2 weeks who did not take painkillers or who took painkillers at a stable dose; 6) during the period of ultrasound treatment, the drug treatment plan should not be adjusted in principle. If the pain is unbearable, adjust the drug treatment plan; 7) before entering the study, patients receiving uric acid-lowering therapy must maintain a stable dose and regimen for more than 2 weeks; 8) there has been no other physiotherapy for the most painful lesions in the past two weeks; 9) the patient or the patient's family members agree and sign the informed consent form, which can cooperate with various examinations during the clinical study.

Exclusion criteria

Exclusion criteria: 1) Rheumatoid arthritis, infectious or other non-infectious arthritis; 2) History of malignant, active, chronic or recurrent infections (including tuberculous arthritis), or infections such as AIDS, syphilis or hepatitis; 3) the skin of the site treated by ultrasound is damaged or broken; 4) use large doses of painkillers (such as glucocorticoids) or illegal drugs (such as opioids) before screening and ultrasound treatment; 5) haemorrhage tendency disease; 6) malignant tumor of any organ system within 5 years; 7) important medical problems include poorly controlled type 1 or type 2 diabetes mellitus (FBG=13.3mmol/l), uncontrollable hypertension (BP= 180/120mmHg), refractory heart failure, unstable arrhythmias, unstable symptomatic coronary artery ischemia, or any other disease that researchers believe may impair the patient's immune function; 8) pregnant and lactating women; 9) people with previous history of mental illness or cognitive impairment; 10) participate in other clinical researchers at the same time; 11) patients who are unable to communicate with researchers or staff.

Design outcomes

Primary

MeasureTime frame
NRS scores;

Secondary

MeasureTime frame
Joint swelling pain index score;Therapeutic effect criterion;Ultrasonic joint examination;

Countries

China

Contacts

Public ContactHaoyong Yu

Shanghai sixth people's Hospital

yuhaoyong111@sjtu.edu.cn+86 189 3017 3807

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026