Sacroiliac Joint DysfunctionNCT06761768
Combined Corticosteroid Injections and Shockwave Therapy for Sacroiliac Joint Pain
A study testing Corticosteroids Triamcinolone Acetonide, extracorporeal shockwave and extracorporeal shockwave(minimum intensity) in people with Sacroiliac Joint Dysfunction and Sacroiliac Joint Pain, run by Tri-Service General Hospital (TSGH).
Trial summary
This study aims to investigate the combined use of corticosteroid injections and ESWT for SIJ pain. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Sacroiliac Joint Dysfunction, Sacroiliac Joint Pain
- What is being tested?
- Corticosteroids Triamcinolone Acetonide, extracorporeal shockwave and extracorporeal shockwave(minimum intensity)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
- Being tested
- Corticosteroids Triamcinolone Acetonide, extracorporeal shockwave, extracorporeal shockwave(minimum intensity)
- Keywords
- Sacroiliac Joint Dysfunction, Sacroiliac joint pain, Steroid Injection, Extracorporeal shock wave therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroids Triamcinolone AcetonideDrug
ultrasound-guided sacroiliac joint corticosteroid injections (1 ml SHINCORT INJ 10 MG/ML + 1 ml 2% Xylocaine)
extracorporeal shockwaveDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Corticosteroids Triamcinolone Acetonide; Device: extracorporeal shockwave |
| 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). Receives: Drug: Corticosteroids Triamcinolone Acetonide; Device: extracorporeal shockwave(minimum intensity) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, one week after treatment, and at 1, 3, and 6 months post-treatment
Secondary outcomes (2)
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.
Measured: baseline, one week after treatment, and at 1, 3, and 6 months post-treatment
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.
Measured: baseline, 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang-Cheng Chen, Tri-Service General Hospital (TSGH)
- Investigators
- Liang cheng Chen, MD, MS, Principal investigator, Department of Physical Medicine and Rehabilitation, Tri-Service General
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761768
- Sponsor's protocol ID
- B202405209
- Status last verified
- Jan 2025
- First submitted
- 1 Jan 2025
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Combining Corticosteroid Injections and Extracorporeal Shockwave Therapy in Patients With Sacroiliac Joint Pain
- ClinicalTrials.gov ID
- NCT06761768
- Acronym / sponsor ID
- B202405209
- Keywords
- Sacroiliac Joint Dysfunction, Sacroiliac joint pain, Steroid Injection, Extracorporeal shock wave therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid Injection and shockwave Therapy | Experimental | Drug: Corticosteroids Triamcinolone Acetonide, Device: extracorporeal shockwaveParticipants 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). |
| Corticosteroid Injection and sham shockwave Therapy | Sham comparator | Drug: Corticosteroids Triamcinolone Acetonide, Device: extracorporeal shockwave(minimum intensity)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). |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corticosteroids Triamcinolone Acetonideultrasound-guided sacroiliac joint corticosteroid injections (1 ml SHINCORT INJ 10 MG/ML + 1 ml 2% Xylocaine) | Drug | Corticosteroid Injection and sham shockwave Therapy, Corticosteroid Injection and shockwave Therapy |
| extracorporeal shockwavea 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 | Corticosteroid Injection and shockwave Therapy |
| 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) | Device | Corticosteroid Injection and sham shockwave Therapy |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liang cheng Chen, MD, MS principal investigator
Department of Physical Medicine and Rehabilitation, Tri-Service General
Questions about this trial
What is this clinical trial studying?
A study testing Corticosteroids Triamcinolone Acetonide, extracorporeal shockwave and extracorporeal shockwave(minimum intensity) in people with Sacroiliac Joint Dysfunction and Sacroiliac Joint Pain, run by Tri-Service General Hospital (TSGH).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liang cheng Chen, MD, MS (886-2-87923311 ext. 12922, clctsgh@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain Visual Analogue Scale(VAS) (time frame: baseline, one week after treatment, and at 1, 3, and 6 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.