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NCT Number: NCT06761768

Combined Corticosteroid Injections and Shockwave Therapy for Sacroiliac Joint Pain

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

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Corticosteroids Triamcinolone Acetonide

Drug

ultrasound-guided sacroiliac joint corticosteroid injections (1 ml SHINCORT INJ 10 MG/ML + 1 ml 2% Xylocaine)

extracorporeal shockwave

Device

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)

extracorporeal shockwave(minimum intensity)

Device

a three-week course of weekly extracorporeal shockwave therapy sessions (intensity: minimum setting on the device; frequency: 5 Hz; 2000 shocks per session)

Primary outcomes

  1. pain Visual Analogue Scale(VAS)

    Time frame: 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.

Secondary outcomes

  1. Oswestry Disability Index, ODI

    Time frame: baseline, one week after treatment, and at 1, 3, and 6 months post-treatment

    The Oswestry Disability Index (ODI) was used to assess the degree of functional impairment caused by low back pain. The index consists of 10 items, each with 6 options scored from 0 to 5, representing varying levels of disability. A score of 0 indicates no disability, while a score of 5 indicates severe disability. The scores for all items are summed to obtain a total score, with a maximum possible score of 50, which is then expressed as a percentage.

  2. Quantitative scintigraphy of the sacroiliac joints

    Time frame: baseline, 3 months post-treatment

    Quantitative scintigraphy of the sacroiliac joints is an imaging technique used to evaluate the sacroiliac joint, commonly employed to diagnose joint issues such as inflammation, joint lesions, or other pathological conditions causing pain. During the scanning process, a radiolabeled substance is typically injected into the body, which accumulates in areas of high bone activity, particularly those with inflammation or injury. This highlights metabolic activity or structural changes within the joint.

Study contacts

Contact information is provided by the study sponsor or research team.

Liang cheng Chen, MD, MS

CONTACT

[email protected]

886-2-87923311 ext. 12922

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2025
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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