Hand Arthritis
Conditions
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
Interventions
PROCEDUREultrasonication-mediated microbubbles dressing
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.
PROCEDUREultrasonication using pure gel
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.
Sponsors
National Taiwan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Ultrafast PD response | day 8 | A ≥20% decrease in synovial PD area on day 8 relative to day 1 on ultrafast PD image |
Countries
Taiwan
Contacts
Primary ContactKuo-Lung Lai
Outcome results
None listed