Ultrasonication-mediated Microbubbles Dressing for Hand Arthritis

NCT ID: NCT06913088

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-02

Study Completion Date

2026-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Hand Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MBUS group

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

Group Type EXPERIMENTAL

ultrasonication-mediated microbubbles dressing

Intervention Type 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.

US group

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

Group Type SHAM_COMPARATOR

ultrasonication using pure gel

Intervention Type 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.

Control group

piroxicam gel alone (day 1-7)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University

OTHER

Sponsor Role lead

Responsible Party

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Kuo-Lung Lai

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Taichung Veterans General Hospital

Taichung, Taichung, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Kuo-Lung Lai

Role: CONTACT

886-4-23592525 ext 3354

Facility Contacts

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Kuo-Lung Lai

Role: primary

886-4-23592525 ext 3354

Other Identifiers

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TCVGH-1123802B

Identifier Type: -

Identifier Source: org_study_id

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