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

January 15, 2026 updated by: Kuo-Lung Lai, Taichung Veterans General Hospital

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ultrasonication in combination with corticosteroid intraarticular injection
Device: Therapeutic 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.
Procedure: Intra-articular corticosteroid injection
Injection of triamcinolone (3-50 mg depending on joint size) into the affected joint. Administered once per participant.
Active Comparator: corticosteroid intraarticular injection
Procedure: Intra-articular corticosteroid injection
Injection of triamcinolone (3-50 mg depending on joint size) into the affected joint. Administered once per participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 2 weeks
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.
From enrollment to the end of treatment at 2 weeks
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.
From enrollment to the end of treatment at 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
From enrollment to 3 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Investigators

  • Principal Investigator: Kuo-Lung Lai, MD, Taichung Veterans General Hospital (TaichungVGH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 29, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCVGH-1150801B
  • CF25511A (Other Identifier: TCVGH IRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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