Ultrasonication-mediated Microbubbles Dressing for Hand Arthritis

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

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

Study Overview

• Status: Recruiting
• Conditions: Hand Arthritis
• Intervention / Treatment: Procedure: ultrasonication-mediated microbubbles dressing; Procedure: ultrasonication using pure gel

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kuo-Lung Lai; Phone Number: 886-4-23592525 ext 3354; Email: kllaichiayi@vghtc.gov.tw

Study Locations

• Taiwan
  • Taichung, Taiwan, 407
    • Recruiting
    • Taichung Veterans General Hospital
    • Contact: Kuo-Lung Lai; Phone Number: 886-4-23592525 ext 3354; Email: kllaichiayi@vghtc.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MBUS group; ultrasonication-mediated microbubbles dressing (day 1,3,5) + piroxicam gel (day 2,4,6,7)	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.
Sham Comparator: US group; ultrasonication using pure gel (day 1,3,5) + piroxicam gel (day 2,4,6,7)	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.
No Intervention: Control group; piroxicam gel alone (day 1-7)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: National Taiwan University

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2025
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: March 29, 2025
• First Submitted That Met QC Criteria: March 29, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Arthritis
• Other Study ID Numbers: TCVGH-1123802B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No