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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBUS group | Experimental | ultrasonication-mediated microbubbles dressing (day 1,3,5) + piroxicam gel (day 2,4,6,7) |
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| US group | Sham Comparator | ultrasonication using pure gel (day 1,3,5) + piroxicam gel (day 2,4,6,7) |
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| Control group | No Intervention | piroxicam gel alone (day 1-7) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasonication-mediated microbubbles dressing | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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] | day 8 |
| B-mode response | A ≥20% decrease in synovial area on day 8 relative to day 1 | 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 | day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrafast PD response | A ≥20% decrease in synovial PD area on day 8 relative to day 1 on ultrafast PD image | day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kuo-Lung Lai | Contact | 886-4-23592525 ext 3354 | kllaichiayi@vghtc.gov.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taichung Veterans General Hospital | Recruiting | Taichung | Taichung | 407 | Taiwan |
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| ultrasonication using pure gel | Procedure | 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. |
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