Ultrasonication-mediated Microbubbles Dressings Increase the Therapeutic Efficacy of Piroxicam Gel for Hand Arthritis: Assessments Using Conventional and Ultrafast Power Doppler Imaging
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- National Taiwan University
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Clinical response
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Clinical response
Time Frame: 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
Time Frame: day 8
A ≥20% decrease in synovial area on day 8 relative to day 1
Conventional power Doppler (PD) response
Time Frame: day 8
A ≥20% decrease in synovial PD area on day 8 relative to day 1 on conventional PD image
Secondary Outcomes
- Ultrafast PD response(day 8)
Investigators
Kuo-Lung Lai
Doctor
National Taiwan University