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Not yet recruiting NCT07363876

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

No phase Interventional Arthritis Ultrasonication Intra-articular Injections Rheumatology

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Therapeutic Ultrasound, Intra-articular corticosteroid injection.
Who it may be relevant to
Registry conditions: Arthritis, Ultrasonication, Intra-articular Injections, Rheumatology. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Reduction in Synovial Swelling Area Assessed by Joint Ultrasound [Time frame: 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]
  • Change in Pain Visual Analogue Scale (VAS) [Time frame: From enrollment to the end of treatment at 2 weeks]
Secondary outcome measures (2)
  • Absence of Synovitis Recurrence Based on Power Doppler (PD) Score [Time frame: 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07363876 · TCVGH-1150801B · CF25511A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗