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Not yet recruitingNCT06761768Updated Jan 9, 2025

Combined Corticosteroid Injections and Shockwave Therapy for Sacroiliac Joint Pain

An interventional study of Corticosteroids Triamcinolone Acetonide and extracorporeal shockwave in Sacroiliac Joint Dysfunction and Sacroiliac Joint Pain, sponsored by Tri-Service General Hospital. Not yet recruiting. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-09.

Sponsored by Tri-Service General Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Sacroiliac Joint Dysfunction
  • Sacroiliac Joint Pain

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Keywords

  • Sacroiliac Joint Dysfunction
  • Sacroiliac joint pain
  • Steroid Injection
  • Extracorporeal shock wave therapy
03

In context

Arthralgia

277 studies on the registry are indexed under Arthralgia; 54 are open to participants now.

This study's planned enrollment of 44 is below the median of 73 across 218 interventional studies indexed under Arthralgia.

Browse Arthralgia studies →

Lead sponsor

Tri-Service General Hospital is the lead sponsor of 108 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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, diseases, or
  • Sacroiliac joint injection therapy received within the past 6 months
  • 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    Corticosteroid Injection and shockwave Therapy

    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).

    Drug: Corticosteroids Triamcinolone Acetonide · Device: extracorporeal shockwave

  • Sham comparator
    Corticosteroid Injection and sham shockwave Therapy

    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).

    Drug: Corticosteroids Triamcinolone Acetonide · Device: extracorporeal shockwave(minimum intensity)

Interventions

  • DrugCorticosteroids Triamcinolone Acetonide

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

  • Deviceextracorporeal 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)

  • Deviceextracorporeal 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)

06

What researchers measure

Primary outcomes

  1. pain Visual Analogue Scale(VAS)

    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.

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

Secondary outcomes

  1. Oswestry Disability Index, ODI

    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.

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

  2. Quantitative scintigraphy of the sacroiliac joints

    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.

    Time frame: baseline, 3 months post-treatment

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06761768
Responsible party
Liang-Cheng Chen (Clinical Professor, Tri-Service General Hospital) — Principal investigator
First posted
Jan 7, 2025
Start date
Aug 1, 2025 (estimated)
Primary completion
Jul 1, 2026 (estimated)
Completion
Jul 31, 2026 (estimated)
Last update
Jan 9, 2025

Study contacts

Liang cheng Chen, MD, MS
Contact
clctsgh@yahoo.com.tw
886-2-87923311 ext. 12922
Liang cheng Chen, MD, MS
principal investigator · Department of Physical Medicine and Rehabilitation, Tri-Service General

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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