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NCT Number: NCT06913088

Ultrasonication-mediated Microbubbles Dressing for Hand Arthritis

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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Key information

Conditions

Hand Arthritis

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taichung Veterans General Hospital

Taichung, 407, Taiwan

Location status: Recruiting

Location contact

Kuo-Lung Lai

CONTACT

[email protected]

886-4-23592525 ext 3354

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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]

  2. B-mode response

    Time frame: day 8

    A ≥20% decrease in synovial area on day 8 relative to day 1

  3. 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

  1. Ultrafast PD response

    Time frame: day 8

    A ≥20% decrease in synovial PD area on day 8 relative to day 1 on ultrafast PD image

Study contacts

Contact information is provided by the study sponsor or research team.

Kuo-Lung Lai

CONTACT

[email protected]

886-4-23592525 ext 3354

Sponsors and collaborators

Lead sponsor

National Taiwan University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 6, 2025
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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