Hand ArthritisNCT06913088
Ultrasonication-mediated Microbubbles Dressing for Hand Arthritis
A study testing ultrasonication-mediated microbubbles dressing and ultrasonication using pure gel in people with Hand Arthritis, run by National Taiwan University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hand Arthritis
- What is being tested?
- ultrasonication-mediated microbubbles dressing and ultrasonication using pure gel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Apr 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of hand arthritis
- Have at least three symptomatic joints over wrist, metacarpophalangeal joints, and interphalangeal joints
Who cannot join
- Infectious arthritis
- Acute gout
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, Taichung, 407
Kuo-Lung Lai, 886-4-23592525 ext 3354, kllaichiayi@vghtc.gov.tw
About this study
Official title: 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?
Read more
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
- Being tested
- ultrasonication-mediated microbubbles dressing, ultrasonication using pure gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonication-mediated microbubbles dressingProcedure or 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 gelProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| MBUS group | Experimental | ultrasonication-mediated microbubbles dressing (day 1,3,5) + piroxicam gel (day 2,4,6,7) Receives: Procedure: ultrasonication-mediated microbubbles dressing |
| US group | Sham comparator | ultrasonication using pure gel (day 1,3,5) + piroxicam gel (day 2,4,6,7) Receives: Procedure: ultrasonication using pure gel |
| Control group | No intervention | piroxicam gel alone (day 1-7) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: day 8
B-mode response
A ≥20% decrease in synovial area on day 8 relative to day 1
Measured: 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
Measured: 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
Measured: day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start2 Apr 2025
- Primary completion1 Jul 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuo-Lung Lai, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913088
- Sponsor's protocol ID
- TCVGH-1123802B
- Status last verified
- Apr 2025
- First submitted
- 29 Mar 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonication-mediated Microbubbles Dressings Increase the Therapeutic Efficacy of Piroxicam Gel for Hand Arthritis: Assessments Using Conventional and Ultrafast Power Doppler Imaging
- ClinicalTrials.gov ID
- NCT06913088
- Acronym / sponsor ID
- TCVGH-1123802B
- Conditions
- Hand Arthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan UniversityUniversity, hospital or other
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MBUS group | Experimental | Procedure: ultrasonication-mediated microbubbles dressingultrasonication-mediated microbubbles dressing (day 1,3,5) + piroxicam gel (day 2,4,6,7) |
| US group | Sham comparator | Procedure: ultrasonication using pure gelultrasonication using pure gel (day 1,3,5) + piroxicam gel (day 2,4,6,7) |
| Control group | No intervention | –piroxicam gel alone (day 1-7) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of hand arthritis
- Have at least three symptomatic joints over wrist, metacarpophalangeal joints, and interphalangeal joints
Key exclusion criteria (2 listed)
- Infectious arthritis
- Acute gout
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasonication-mediated microbubbles dressingThe 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. | Procedure or surgery | MBUS group |
| ultrasonication using pure gelThe 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. | Procedure or surgery | US group |
Primary outcome
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]
B-mode response
Time frame: day 8
A ≥20% decrease in synovial area on day 8 relative to day 1
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
1 secondary outcome
Ultrafast PD response
Time frame: day 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
Related trials for Hand Arthritis
Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Recruiting
Woodcasting Versus Thermoplast Splint in CMC Arthroplasty
Carpometacarpal (CMC) Joint Arthritis
Not yet recruiting
Development and Evaluation of the Effectiveness of the SMART-HAND Protocol for Hand Rehabilitation in Patients With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA
Recruiting
Vibratory Anesthesia on Pain Following Corticosteroid Injections
Bilateral Arthritis of Wrist, Tendinopathy
Recruiting
Trapeziectomy and Suture Suspensionplasty for Thumb Carpometacarpal Arthritis - Is In-Clinic Therapy Needed?
CMC Arthritis, Occupational Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasonication-mediated microbubbles dressing and ultrasonication using pure gel in people with Hand Arthritis, run by National Taiwan University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kuo-Lung Lai (886-4-23592525 ext 3354, kllaichiayi@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response (time frame: day 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.