Ultrasonication-mediated Microbubbles Dressing for Hand Arthritis

NCT06913088 | Recruiting

• 1 other identifier: TCVGH-1123802B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Hand Arthritis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Ultrafast PD response

  day 8

Study Arms (3)

MBUS group

EXPERIMENTAL

ultrasonication-mediated microbubbles dressing (day 1,3,5) + piroxicam gel (day 2,4,6,7)

Procedure: ultrasonication-mediated microbubbles dressing

US group

SHAM COMPARATOR

ultrasonication using pure gel (day 1,3,5) + piroxicam gel (day 2,4,6,7)

Procedure: ultrasonication using pure gel

Control group

NO INTERVENTION

piroxicam gel alone (day 1-7)

Interventions

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.

MBUS group

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.

US group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of hand arthritis
• Have at least three symptomatic joints over wrist, metacarpophalangeal joints, and interphalangeal joints

You may not qualify if:

• Infectious arthritis
• Acute gout

Sponsors & Collaborators

• National Taiwan University: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taichung, 407, Taiwan

RECRUITING

Central Study Contacts

Kuo-Lung Lai

CONTACT

886-4-23592525 ext 3354; kllaichiayi@vghtc.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: April 6, 2025
• Study Start: April 2, 2025
• Primary Completion: July 1, 2025
• Study Completion: March 31, 2026
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

TW (1)