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

Обзор

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.

Вмешательства

• Устройство 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.
• Процедура Intra-articular corticosteroid injection
  Injection of triamcinolone (3-50 mg depending on joint size) into the affected joint. Administered once per participant.

Первичные конечные точки

• Reduction in Synovial Swelling Area Assessed by Joint Ultrasound [Срок оценки: From enrollment to the end of treatment at 2 weeks]
• Change in Power Doppler (PD) Score of the Target Joint [Срок оценки: From enrollment to the end of treatment at 2 weeks]
• Change in Pain Visual Analogue Scale (VAS) [Срок оценки: From enrollment to the end of treatment at 2 weeks]

Вторичные конечные точки (2)

• Absence of Synovitis Recurrence Based on Power Doppler (PD) Score [Срок оценки: From enrollment to 3 months post-treatment]
• Absence of Synovial Swelling Recurrence on Gray-Scale Ultrasound [Срок оценки: From enrollment to 3 months post-treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07363876 · TCVGH-1150801B · CF25511A

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗