Combined Corticosteroid Injections and Shockwave Therapy for Sacroiliac Joint Pain

January 7, 2025 updated by: Liang-Cheng Chen, Tri-Service General Hospital

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, one week after treatment, and at 1, 3, and 6 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
baseline, 3 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital

Investigators

  • Principal Investigator: Liang cheng Chen, MD, MS, Department of Physical Medicine and Rehabilitation, Tri-Service General

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

January 1, 2025

First Submitted That Met QC Criteria

January 1, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 7, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B202405209

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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