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临床试验/NCT06761768
NCT06761768尚未招募不适用

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

Tri-Service General Hospital0 个研究点目标入组 44 人开始时间: 2025年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
44
主要终点
pain Visual Analogue Scale(VAS)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Corticosteroid Injection and shockwave Therapy

Experimental

Participants received ultrasound-guided sacroiliac joint corticosteroid injections (1 ml SHINCORT INJ 10 MG/ML + 1 ml 2% Xylocaine). One week later, they began 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).

干预措施: Corticosteroids Triamcinolone Acetonide (Drug)

Corticosteroid Injection and shockwave Therapy

Experimental

Participants received ultrasound-guided sacroiliac joint corticosteroid injections (1 ml SHINCORT INJ 10 MG/ML + 1 ml 2% Xylocaine). One week later, they began 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).

干预措施: extracorporeal shockwave (Device)

Corticosteroid Injection and sham shockwave Therapy

Sham Comparator

Participants received ultrasound-guided sacroiliac joint corticosteroid injections (1 ml SHINCORT INJ 10 MG/ML + 1 ml 2% Xylocaine). One week later, they began a three-week course of weekly extracorporeal shockwave therapy sessions (intensity: minimum setting on the device; frequency: 5 Hz; 2000 shocks per session).

干预措施: Corticosteroids Triamcinolone Acetonide (Drug)

Corticosteroid Injection and sham shockwave Therapy

Sham Comparator

Participants received ultrasound-guided sacroiliac joint corticosteroid injections (1 ml SHINCORT INJ 10 MG/ML + 1 ml 2% Xylocaine). One week later, they began a three-week course of weekly extracorporeal shockwave therapy sessions (intensity: minimum setting on the device; frequency: 5 Hz; 2000 shocks per session).

干预措施: extracorporeal shockwave(minimum intensity) (Device)

结局指标

主要结局

pain Visual Analogue Scale(VAS)

时间窗: baseline, one week after treatment, and at 1, 3, and 6 months post-treatment

The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. "0" means painless and "10" means extremely painful.

次要结局

  • Oswestry Disability Index, ODI(baseline, one week after treatment, and at 1, 3, and 6 months post-treatment)
  • Quantitative scintigraphy of the sacroiliac joints(baseline, 3 months post-treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Liang-Cheng Chen

Clinical Professor

Tri-Service General Hospital

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