Ultrasonication-mediated Microbubbles Dressing for Hand Arthritis

Not Applicable

Recruiting

• Conditions: Hand Arthritis

• Registration Number: NCT06913088
• Lead Sponsor: National Taiwan University

Brief Summary

The goal of this clinical trial is to learn if ultrasonication-mediated microbubbles dressing works to treat hand arthritis in adults. It will also learn about the safety of ultrasonication-mediated microbubbles dressing. The main questions it aims to answer are:

Does ultrasonication-mediated microbubbles dressing increase the therapeutic efficacy of piroxicam gel for hand arthritis?

Researchers will compare "ultrasonication-mediated microbubbles dressing + piroxicam gel " to "ultrasonication + piroxicam gel" and "piroxicam gel alone" to see if ultrasonication-mediated microbubbles dressing works to treat hand arthritis.

Participants will:

Take "ultrasonication-mediated microbubbles dressing (day 1,3,5) + piroxicam gel (day 2,4,6,7) ", "ultrasonication (day 1,3,5) + piroxicam gel (day 2.4.6.7)", and "piroxicam gel alone (day 1-7)" for 1 week.

Visit the clinic on day 1 and day 8 for checkups and tests Keep a diary of their symptoms

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-29
• Study First Submitted QC: 2025-03-29
• Status Verified: 2025-04
• Study Start: 2025-04-02
• Study First Posted: 2025-04-06
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-07-01
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Clinical diagnosis of hand arthritis
• Have at least three symptomatic joints over wrist, metacarpophalangeal joints, and interphalangeal joints

Exclusion Criteria

• Infectious arthritis
• Acute gout

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical response	day 8	A decrease in pain visual analogue scale (VAS) score of ≥2 on day 8 relative to day 1, or an absolute VAS score of ≤1 on day 8.; \[Pain VAS score range: 0-10, higher scores mean a worse outcome\]
B-mode response	day 8	A ≥20% decrease in synovial area on day 8 relative to day 1
Conventional power Doppler (PD) response	day 8	A ≥20% decrease in synovial PD area on day 8 relative to day 1 on conventional PD image

Secondary Outcome Measures

Name	Time	Method
Ultrafast PD response	day 8	A ≥20% decrease in synovial PD area on day 8 relative to day 1 on ultrafast PD image

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan