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RecruitingNCT07363876Updated Sep 30, 2026

The Efficacy of Ultrasonication in Combination With Corticosteroid Intraarticular Injection for Arthritis

An interventional study of Therapeutic Ultrasound and Intra-articular corticosteroid injection in Arthritis, Ultrasonication and Intra-articular Injections, sponsored by Taichung Veterans General Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Taichung Veterans General Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Arthritis
  • Ultrasonication
  • Intra-articular Injections
  • Rheumatology

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    ultrasonication in combination with corticosteroid intraarticular injection

    Device: Therapeutic Ultrasound · Procedure: Intra-articular corticosteroid injection

  • Active comparator
    corticosteroid intraarticular injection

    Procedure: Intra-articular corticosteroid injection

Interventions

  • DeviceTherapeutic Ultrasound

    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.

  • ProcedureIntra-articular corticosteroid injection

    Injection of triamcinolone (3-50 mg depending on joint size) into the affected joint. Administered once per participant.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment to the end of treatment at 2 weeks

  2. 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.

    Time frame: From enrollment to the end of treatment at 2 weeks

  3. 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.

    Time frame: From enrollment to the end of treatment at 2 weeks

Secondary outcomes

  1. 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.

    Time frame: From enrollment to 3 months post-treatment

  2. 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.

    Time frame: From enrollment to 3 months post-treatment

06

Study locations

1 of 1 sites recruiting
  • Taichung Veterans General Hospital
    Taichung, 407219, Taiwan
    Recruiting
07

Registry details

Key details

Study ID
NCT07363876
Lead sponsor
Taichung Veterans General Hospital
Responsible party
Kuo-Lung Lai (Principal Investigator, Taichung Veterans General Hospital) — Principal investigator
First posted
Jan 23, 2026
Start date
Feb 26, 2026
Primary completion
Nov 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 30, 2026

Study contacts

Kuo-Lung Lai, MD
Contact
kllaichiayi@yahoo.com.tw
+886-4-2359-2525
Kuo-Lung Lai, MD
principal investigator · Taichung Veterans General Hospital (TaichungVGH)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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