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Recruiting NCT06913088

Ultrasonication-mediated Microbubbles Dressing for Hand Arthritis

No phase Interventional Hand Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ultrasonication-mediated microbubbles dressing, ultrasonication using pure gel.
Who it may be relevant to
Registry conditions: Hand Arthritis. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Ultrasonication-mediated Microbubbles Dressings Increase the Therapeutic Efficacy of Piroxicam Gel for Hand Arthritis: Assessments Using Conventional and Ultrafast Power Doppler Imaging

Overview

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

  • Procedure ultrasonication-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.
  • Procedure ultrasonication 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.

Primary outcome measures

  • Clinical response [Time frame: day 8]
  • B-mode response [Time frame: day 8]
  • Conventional power Doppler (PD) response [Time frame: day 8]
Secondary outcome measures (1)
  • Ultrafast PD response [Time frame: day 8]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Taichung Veterans General Hospital — Taichung

Identifiers

NCT: NCT06913088 · TCVGH-1123802B

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗