An interventional study of ultrasonication-mediated microbubbles dressing and ultrasonication using pure gel in Hand Arthritis, sponsored by National Taiwan University. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-04-17.
Sponsored by National Taiwan University · Not applicable, Interventional, and Treatment
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
National Taiwan University is the lead sponsor of 22 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
ultrasonication-mediated microbubbles dressing (day 1,3,5) + piroxicam gel (day 2,4,6,7)
Procedure: ultrasonication-mediated microbubbles dressing
ultrasonication using pure gel (day 1,3,5) + piroxicam gel (day 2,4,6,7)
Procedure: ultrasonication using pure gel
piroxicam gel alone (day 1-7)
The microbubble suspension is diluted with normal saline to a concentration of 2x10\^7 bubbles/mL, applied to a gauze cloth, and covered on the joint skin surface. The joint is ultrasonicated for 3 minutes using an ultrasonic implanter (KUM-2000, NEO-TEC, Taipei, Taiwan), and then piroxicam gel is applied. The parameter values for ultrasonication are duty cycle 0.5, Tempo 10, intensity 70%, and time 3 min. This treatment is performed on day 1, 3, and 5.
The joint is ultrasonicated for 3 minutes using an ultrasonic implanter (KUM-2000, NEO-TEC, Taipei, Taiwan) with pure gel, and then piroxicam gel is applied. The parameter values for ultrasonication are duty cycle 0.5, Tempo 10, intensity 70%, and time 3 min. This treatment is performed on day 1, 3, and 5.
Clinical response
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. \[Pain VAS score range: 0-10, higher scores mean a worse outcome\]
Time frame: day 8
B-mode response
A ≥20% decrease in synovial area on day 8 relative to day 1
Time frame: day 8
Conventional power Doppler (PD) response
A ≥20% decrease in synovial PD area on day 8 relative to day 1 on conventional PD image
Time frame: day 8
Ultrafast PD response
A ≥20% decrease in synovial PD area on day 8 relative to day 1 on ultrafast PD image
Time frame: day 8
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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