Combined Corticosteroid Injections and Shockwave Therapy for Sacroiliac Joint Pain

Официальное название

Efficacy of Combining Corticosteroid Injections and Extracorporeal Shockwave Therapy in Patients With Sacroiliac Joint Pain

Обзор

This study aims to investigate the combined use of corticosteroid injections and ESWT for SIJ pain.

Подробное описание

The most common primary cause of pain and stiffness from the SIJ is sacroiliac joint dysfunction. Currently, conservative treatments for SIJ dysfunction-related pain include oral anti-inflammatory pain medications, exercise therapy, physical therapy, and local injection therapies such as corticosteroids, dextrose, and platelet-rich plasma. Although there are multiple non-surgical options available for SIJ pain management, clear treatment guidelines have not yet been established. Among these options, intra-articular corticosteroid injections in the SIJ are frequently used by rehabilitation specialists in clinical practice, and their effectiveness in relieving pain from SIJ dysfunction has been demonstrated. However, the effects of corticosteroids in treating musculoskeletal-related diseases are typically short-term. Extracorporeal shock wave therapy (ESWT) has become increasingly common in the management of musculoskeletal conditions such as calcific tendinitis, tennis elbow, and plantar fasciitis, showing long-lasting benefits and inducing tissue repair responses that studies suggest may last up to two years. However, literature on ESWT for lower back pain is limited, and research on its use for SIJ pain is even rarer. Therefore, this study aims to investigate the combined use of corticosteroid injections and ESWT for SIJ pain, aiming to achieve rapid, short-term pain relief through corticosteroid injections, followed by potential long-term effects through ESWT.

Вмешательства

• Препарат Corticosteroids Triamcinolone Acetonide
  ultrasound-guided sacroiliac joint corticosteroid injections (1 ml SHINCORT INJ 10 MG/ML + 1 ml 2% Xylocaine)
• Устройство extracorporeal shockwave
  a three-week course of weekly extracorporeal shockwave therapy sessions (intensity: low to moderate, adjusted based on patient tolerance; frequency: 5 Hz; 2000 shocks per session)
• Устройство extracorporeal shockwave(minimum intensity)
  a three-week course of weekly extracorporeal shockwave therapy sessions (intensity: minimum setting on the device; frequency: 5 Hz; 2000 shocks per session)

Первичные конечные точки

• pain Visual Analogue Scale(VAS) [Срок оценки: baseline, one week after treatment, and at 1, 3, and 6 months post-treatment]

Вторичные конечные точки (2)

• Oswestry Disability Index, ODI [Срок оценки: baseline, one week after treatment, and at 1, 3, and 6 months post-treatment]
• Quantitative scintigraphy of the sacroiliac joints [Срок оценки: baseline, 3 months post-treatment]

Критерии участия

Критерии включения

• Low back pain lasting for 3 months or more
• Pain VAS score of 4 or higher
• Three or more positive results in sacroiliac joint provocation tests
• At least 50% pain relief following ultrasound-guided sacroiliac joint injection with local anesthetic

Критерии исключения

• Currently undergoing extracorporeal shockwave therapy in other areas
• Suspected pain caused by other lumbar spine or hip joint conditions (e.g., lumbar spine or disc disorders, radicular pain, spondylolisthesis/disc degeneration, hip arthritis)
• Presence of complex comorbidities, including trauma, systemic infections (e.g., fever, chills, night sweats), local sacroiliac joint infections, autoimmune diseases, or immunosuppression
• Sacroiliac joint injection therapy received within the past 6 months
• Contraindications for extracorporeal shockwave therapy (e.g., cancer or current/prior infections at the treatment site, pacemakers, pregnancy, epilepsy, or coagulation disorders caused by disease or medication)
• Impaired renal function preventing the administration of contrast agents for sacroiliac joint bone scanning

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06761768 · B202405209

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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