ArthritisNCT07363876
The Efficacy of Ultrasonication in Combination With Corticosteroid Intraarticular Injection for Arthritis
A study testing Therapeutic Ultrasound and Intra-articular corticosteroid injection in people with Arthritis and Ultrasonication, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
This study investigates whether ultrasound therapy applied prior to intra-articular corticosteroid injection can enhance the treatment efficacy for patients with joint arthritis and assess its safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Ultrasonication, Intra-articular Injections
- What is being tested?
- Therapeutic Ultrasound and Intra-articular corticosteroid injection
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Feb 2026to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Diagnosed with arthritis in the limbs.
- Inadequate response to or contraindication for oral anti-inflammatory medications.
- Assessed by a physician as requiring intra-articular corticosteroid injection.
Who cannot join
- History of joint replacement (prosthetic joint) in the affected area.
- Hip joint involvement.
- Diagnosis of gout.
- Infectious arthritis.
- Presence of cellulitis at the treatment site.
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, 407219
Kuo-Lung Lai, MD, +886-4-2359-2525, kllaichiayi@yahoo.com.tw
About this study
This study investigates whether ultrasound therapy applied prior to intra-articular corticosteroid injection can enhance the treatment efficacy for patients with joint arthritis and assess its safety. Adult patients diagnosed with arthritis in the limbs who are indicated for corticosteroid injection are eligible, while patients with joint replacement, hip joint involvement, gout, infectious arthritis, or local cellulitis are excluded.
Ultrasound therapy is a valuable physical therapy tool for musculoskeletal diseases, producing therapeutic effects through thermal and non-thermal mechanisms. It can improve tissue extensibility, reduce joint stiffness, increase local blood flow, enhance metabolism during tissue repair, and facilitate drug absorption. This study evaluates whether applying ultrasound before intra-articular corticosteroid injection improves therapeutic outcomes in patients with arthritis, and assesses the safety of this combined intervention. Patients aged 18 or older, diagnosed with limb arthritis, and indicated for corticosteroid injection are eligible. Exclusion criteria include joint replacement, hip joint involvement, gout, infectious arthritis, or local cellulitis at the treatment site.
- Conditions
- Arthritis, Ultrasonication, Intra-articular Injections, Rheumatology
- Being tested
- Therapeutic Ultrasound, Intra-articular corticosteroid injection
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic UltrasoundDevice
Therapeutic Ultrasound (TUS) is a non-invasive treatment widely used in physical medicine and rehabilitation for musculoskeletal conditions. Since its introduction in the mid-20th century, TUS has gained popularity in clinical practice due to its ability to penetrate tissues, target treatment areas precisely, and exhibit minimal side effects. This study aims to investigate the mechanisms of action, clinical efficacy, and safety of therapeutic ultrasound in musculoskeletal therapy.
Intra-articular corticosteroid injectionProcedure or surgery
Injection of triamcinolone (3-50 mg depending on joint size) into the affected joint. Administered once per participant.
| Study group | Role | What they receive |
|---|---|---|
| ultrasonication in combination with corticosteroid intraarticular injection | Experimental | Not described Receives: Device: Therapeutic Ultrasound; Procedure: Intra-articular corticosteroid injection |
| corticosteroid intraarticular injection | Active comparator | Not described Receives: Procedure: Intra-articular corticosteroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Synovial Swelling Area Assessed by Joint Ultrasound
Synovial swelling area (pixels) assessed by joint ultrasound. A treatment response is defined as a ≥50% reduction in synovial swelling area from baseline.
Measured: From enrollment to the end of treatment at 2 weeks
Change in Power Doppler (PD) Score of the Target Joint
Power Doppler (PD) score (range 0-3) of the target joint assessed by joint ultrasound. A treatment response is defined as a PD score of 0 at 2 weeks post-treatment.
Measured: From enrollment to the end of treatment at 2 weeks
Change in Pain Visual Analogue Scale (VAS)
Pain intensity assessed using a visual analogue scale (VAS 0-10). A treatment response is defined as a ≥50% reduction in VAS score from baseline or a VAS score ≤1 at 2 weeks post-treatment.
Measured: From enrollment to the end of treatment at 2 weeks
Secondary outcomes (2)
Absence of Synovitis Recurrence Based on Power Doppler (PD) Score
Absence of synovitis recurrence assessed by Power Doppler (PD) ultrasound. Recurrence is defined as any increase in PD score compared with the 2-week post-treatment assessment.
Measured: From enrollment to 3 months post-treatment
Absence of Synovial Swelling Recurrence on Gray-Scale Ultrasound
Absence of synovial swelling recurrence assessed by gray-scale ultrasound. Recurrence is defined as an increase in synovial swelling area of ≥20% compared with the 2-week post-treatment assessment.
Measured: From enrollment to 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start26 Feb 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuo-Lung Lai, Taichung Veterans General Hospital
- Investigators
- Kuo-Lung Lai, MD, Principal investigator, Taichung Veterans General Hospital (TaichungVGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363876
- Sponsor's protocol ID
- TCVGH-1150801B
- Other IDs
- CF25511A
- Status last verified
- Sep 2026
- First submitted
- 8 Jan 2026
- Last updated
- 30 Sep 2026
- 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Ultrasonication in Combination With Corticosteroid Intraarticular Injection for Arthritis
- ClinicalTrials.gov ID
- NCT07363876
- Acronym / sponsor ID
- TCVGH-1150801B
- Conditions
- Arthritis, Ultrasonication, Intra-articular Injections, Rheumatology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jan 2026 (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.
This study investigates whether ultrasound therapy applied prior to intra-articular corticosteroid injection can enhance the treatment efficacy for patients with joint arthritis and assess its safety. Adult patients diagnosed with arthritis in the limbs who are indicated for corticosteroid injection are eligible, while patients with joint replacement, hip joint involvement, gout, infectious arthritis, or local cellulitis are excluded.
Ultrasound therapy is a valuable physical therapy tool for musculoskeletal diseases, producing therapeutic effects through thermal and non-thermal mechanisms. It can improve tissue extensibility, reduce joint stiffness, increase local blood flow, enhance metabolism during tissue repair, and facilitate drug absorption. This study evaluates whether applying ultrasound before intra-articular corticosteroid injection improves therapeutic outcomes in patients with arthritis, and assesses the safety of this combined intervention. Patients aged 18 or older, diagnosed with limb arthritis, and indicated for corticosteroid injection are eligible. Exclusion criteria include joint replacement, hip joint involvement, gout, infectious arthritis, or local cellulitis at the treatment site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasonication in combination with corticosteroid intraarticular injection | Experimental | Device: Therapeutic Ultrasound, Procedure: Intra-articular corticosteroid injection |
| corticosteroid intraarticular injection | Active comparator | Procedure: Intra-articular corticosteroid injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Diagnosed with arthritis in the limbs.
- Inadequate response to or contraindication for oral anti-inflammatory medications.
- Assessed by a physician as requiring intra-articular corticosteroid injection.
Key exclusion criteria (5 listed)
- History of joint replacement (prosthetic joint) in the affected area.
- Hip joint involvement.
- Diagnosis of gout.
- Infectious arthritis.
- Presence of cellulitis at the treatment site.
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 |
|---|---|---|
| Therapeutic UltrasoundTherapeutic Ultrasound (TUS) is a non-invasive treatment widely used in physical medicine and rehabilitation for musculoskeletal conditions. Since its introduction in the mid-20th century, TUS has gained popularity in clinical practice due to its ability to penetrate tissues, target treatment areas precisely, and exhibit minimal side effects. This study aims to investigate the mechanisms of action, clinical efficacy, and safety of therapeutic ultrasound in musculoskeletal therapy. | Device | ultrasonication in combination with corticosteroid intraarticular injection |
| Intra-articular corticosteroid injectionInjection of triamcinolone (3-50 mg depending on joint size) into the affected joint. Administered once per participant. | Procedure or surgery | corticosteroid intraarticular injection, ultrasonication in combination with corticosteroid intraarticular injection |
Primary outcome
Reduction in Synovial Swelling Area Assessed by Joint Ultrasound
Time frame: From enrollment to the end of treatment at 2 weeks
Synovial swelling area (pixels) assessed by joint ultrasound. A treatment response is defined as a ≥50% reduction in synovial swelling area from baseline.
Change in Power Doppler (PD) Score of the Target Joint
Time frame: From enrollment to the end of treatment at 2 weeks
Power Doppler (PD) score (range 0-3) of the target joint assessed by joint ultrasound. A treatment response is defined as a PD score of 0 at 2 weeks post-treatment.
Change in Pain Visual Analogue Scale (VAS)
Time frame: From enrollment to the end of treatment at 2 weeks
Pain intensity assessed using a visual analogue scale (VAS 0-10). A treatment response is defined as a ≥50% reduction in VAS score from baseline or a VAS score ≤1 at 2 weeks post-treatment.
2 secondary outcomes
Absence of Synovitis Recurrence Based on Power Doppler (PD) Score
Time frame: From enrollment to 3 months post-treatment
Absence of Synovial Swelling Recurrence on Gray-Scale Ultrasound
Time frame: From enrollment to 3 months post-treatment
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 30 Sep 2026.
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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.
Kuo-Lung Lai, MD principal investigator
Taichung Veterans General Hospital (TaichungVGH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Ultrasound and Intra-articular corticosteroid injection in people with Arthritis and Ultrasonication, run by Taichung Veterans General Hospital 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 4 inclusion and 5 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 30 Sep 2026. 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. 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, MD (+886-4-2359-2525, kllaichiayi@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Synovial Swelling Area Assessed by Joint Ultrasound (time frame: From enrollment to the end of treatment at 2 weeks). 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 30 Sep 2026.