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Not yet recruiting NCT06761768

Combined Corticosteroid Injections and Shockwave Therapy for Sacroiliac Joint Pain

No phase Interventional Sacroiliac Joint Dysfunction Sacroiliac Joint Pain

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: Corticosteroids Triamcinolone Acetonide, extracorporeal shockwave, extracorporeal shockwave(minimum intensity).
Who it may be relevant to
Registry conditions: Sacroiliac Joint Dysfunction, Sacroiliac Joint Pain. Basic parameters: 20 years — 75 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 →
Official title

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

Overview

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

Detailed description

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.

Interventions

  • Drug Corticosteroids Triamcinolone Acetonide
    ultrasound-guided sacroiliac joint corticosteroid injections (1 ml SHINCORT INJ 10 MG/ML + 1 ml 2% Xylocaine)
  • Device 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)
  • Device 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)

Primary outcome measures

  • pain Visual Analogue Scale(VAS) [Time frame: baseline, one week after treatment, and at 1, 3, and 6 months post-treatment]
Secondary outcome measures (2)
  • Oswestry Disability Index, ODI [Time frame: baseline, one week after treatment, and at 1, 3, and 6 months post-treatment]
  • Quantitative scintigraphy of the sacroiliac joints [Time frame: baseline, 3 months post-treatment]

Eligibility criteria

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

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
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06761768 · B202405209

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗