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

NCT07363876 | Not Yet Recruiting

• 2 other identifiers: TCVGH-1150801BCF25511A
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Arthritis; Ultrasonication; Intra-articular Injections; Rheumatology

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  From enrollment to the end of treatment at 2 weeks

Secondary Outcomes (2)

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

  From enrollment to 3 months post-treatment

• Absence of Synovial Swelling Recurrence on Gray-Scale Ultrasound

  From enrollment to 3 months post-treatment

Study Arms (2)

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

Interventions

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.

ultrasonication in combination with corticosteroid intraarticular injection

Intra-articular corticosteroid injection PROCEDURE

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

corticosteroid intraarticular injection; ultrasonication in combination with corticosteroid intraarticular injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

MeSH Terms

Conditions

Arthritis

Interventions

Ultrasonic Therapy; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Kuo-Lung Lai, MD

  Taichung Veterans General Hospital (TaichungVGH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuo-Lung Lai, MD

CONTACT

+886-4-2359-2525; kllaichiayi@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 23, 2026
• Study Start: December 29, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 23, 2026

Record last verified: 2025-12