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Ultrasonication-mediated Microbubbles Dressing for Hand Arthritis

ConditionHand Arthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Taiwan University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of hand arthritis

Have at least three symptomatic joints over wrist, metacarpophalangeal joints, and interphalangeal joints

Disqualifiers

Infectious arthritis

Acute gout

Trial design

Design model

Parallel

Treatments tested in this trial

  • ultrasonication-mediated microbubbles dressing

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: MBUS groupExperimental treatment 1 intervention
Group B: US groupSham comparator 1 intervention
Group C: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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. \[Pain VAS score range: 0-10, higher scores mean a worse outcome\]

Time frame
day 8
2

B-mode response

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

Time frame
day 8
3

Conventional power Doppler (PD) response

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

Time frame
day 8

Secondary outcomes

1

Ultrafast PD response

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

Time frame
day 8

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University

Lead sponsor

Source ClinicalTrials.gov
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