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NCT Number: NCT07363876

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

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.

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Key information

Conditions

Arthritis Intra-articular Injections Joint Diseases Musculoskeletal Diseases Rheumatology Ultrasonication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Therapeutic Ultrasound

Device

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 injection

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Absence of Synovitis Recurrence Based on Power Doppler (PD) Score

    Time frame: From enrollment to 3 months post-treatment

    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.

  2. Absence of Synovial Swelling Recurrence on Gray-Scale Ultrasound

    Time frame: From enrollment to 3 months post-treatment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kuo-Lung Lai, MD

CONTACT

[email protected]

+886-4-2359-2525

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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