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

NCT07363876 — Not applicable, Recruiting, 100 participants, Taichung Veterans General Hospital

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Registry	NCT07363876
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	100 (Estimated)
Sponsor	Taichung Veterans General Hospital (Other)
Conditions	Arthritis, Ultrasonication, Intra-articular Injections, Rheumatology
Interventions	Therapeutic Ultrasound, Intra-articular corticosteroid injection (Device, procedure)
Dates	start 2026-02-26, primary completion 2026-11-30 (estimated), completion 2026-12-31 (estimated), first posted 2026-01-23, last updated 2026-09-30
Locations	1 site in Taiwan

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
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

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.

+Outcome measures

Primary outcomes

Reduction in Synovial Swelling Area Assessed by Joint Ultrasound [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 [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) [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

Absence of Synovitis Recurrence Based on Power Doppler (PD) Score [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.
Absence of Synovial Swelling Recurrence on Gray-Scale Ultrasound [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.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Taichung Veterans General Hospital	Taichung	Taiwan	Recruiting

+Investigators

Kuo-Lung Lai, MD, Principal investigator, Taichung Veterans General Hospital (TaichungVGH)