SacroiliitisNCT07791108
Outcomes of Intra-articular Steroid Injection Via Ultrasound Guidance Versus Fluoroscopic Guidance in the Sacroiliac Joint in Patients With Sacroiliitis
A study testing Ultrasound-guided intra-articular steroid injection in people with Sacroiliitis, run by Allied Hospital Faisalabad at 1 site in Pakistan.
Trial summary
Sacroiliitis is a common cause of low back and buttock pain. Intra-articular steroid injection of the sacroiliac joint can provide pain relief and functional improvement. This randomized controlled trial aims to compare the outcomes of ultrasound-guided versus fluoroscopic-guided sacroiliac joint steroid injections in… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sacroiliitis
- What is being tested?
- Ultrasound-guided intra-articular steroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Sep 2026to 27 Nov 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years
- Both sexes
- Clinical diagnosis of sacroiliitis
Who cannot join
- Prior SI joint injection in the past 12 months
- Contraindication to corticosteroid injection (systemic infection, local infection, bleeding diathesis, uncontrolled diabetes with HbA1c >9%, allergy to contrast or steroid)
- Radicular or neurogenic pain attributable to lumbar spine or hip pathology
- Pregnancy or breastfeeding
- Severe osteoarthritis or fusion of the SI joint on imaging
- Systemic rheumatologic disease requiring systemic biologic therapy (unless stable for >6 months)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Sacroiliitis is a common cause of low back and buttock pain. Intra-articular steroid injection of the sacroiliac joint can provide pain relief and functional improvement. This randomized controlled trial aims to compare the outcomes of ultrasound-guided versus fluoroscopic-guided sacroiliac joint steroid injections in patients with sacroiliitis. The study will evaluate procedural success, pain reduction, and functional improvement using the Visual Analogue Scale (VAS) and Oswestry Disability Index (ODI) at follow-up intervals.
Read the detailed description
The sacroiliac joint (SIJ) is increasingly recognized as a contributor to low back pain (LBP), with epidemiological estimates attributing approximately 10-30 % of mechanical low back pain cases to SIJ pathology1. Anatomically, the SIJ is a synovial-type (inferior portion) or syndesmosis-type (superior portion) joint between the sacrum and the ilium, supported by substantial interosseous, posterior and anterior ligaments and innervated by dorsal sacral rami and lower lumbar dorsal rami2. Inflammatory involvement of the SIJ occurs in conditions such as axial spondyloarthritis and may also arise post-traumatically or degeneratively3.
NSAIDs and physical therapies are used to treat sacroiliitis. However, intraarticular corticosteroid injections administered locally to the SI joint might result in rapid and significant clinical improvements in extremely painful instances4,5. Fluoroscope guided (FL) is usually employed to increase the precision of this treatment, however CT and MRI have also been used in recent years. These imaging techniques have a number of drawbacks, such as radiation exposure, expense, and the need for suitable infrastructure6. A new alternative technique for guiding SIJ injection is ultrasound (US) guidance. The advantages of US-guided injection over FL include that it eliminates radiation exposure, is more accessible, and is less expensive when used alone. Additionally, the US permits "real-time" visualisation of the injectate distribution and needle tip during injection.7,8.
- Conditions
- Sacroiliitis
- Being tested
- Ultrasound-guided intra-articular steroid injection
- Keywords
- Sacroillitis, Triamcinolone
- Medical subject headings
- Sacroiliitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided intra-articular steroid injectionProcedure or surgery
Also called Ultrasound-guided SI Joint Injection
Participants will receive intra-articular sacroiliac joint steroid injection under ultrasound guidance. A needle will be advanced under real-time ultrasound guidance to the sacroiliac joint, and 40 mg triamcinolone acetonide mixed with 1 mL 0.25% bupivacaine will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided SI Joint Injection | Experimental | Participants will receive sacroiliac joint steroid injection under ultrasound guidance using 40 mg triamcinolone acetonide mixed with 1 mL 0.25% bupivacaine. Receives: Procedure: Ultrasound-guided intra-articular steroid injection |
| Fluoroscopic-guided SI Joint Injection | Active comparator | Participants will receive sacroiliac joint steroid injection under fluoroscopic guidance with contrast confirmation followed by the same steroid-bupivacaine injection. Receives: Procedure: Ultrasound-guided intra-articular steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success rate of sacroiliac joint injection
Successful intra-articular deposition of steroid in the sacroiliac joint confirmed by the respective imaging guidance modality (ultrasound or fluoroscopy).
Measured: During the procedure
Secondary outcomes (1)
Oswestry Disability Index (ODI) Score
The Oswestry Disability Index (ODI) is a validated patient-reported outcome measure used to assess disability related to low back pain. Scores range from 0 to 100, with higher scores indicating greater disability and worse functional status.
Measured: Baseline, 2 weeks, 1 month, and 3 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start27 Sep 2026 (estimated)
- Primary completion27 Nov 2026 (estimated)
- Study completion27 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SacroiliitisStudies 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
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive intra-articular sacroiliac joint steroid injection either under ultrasound guidance or fluoroscopic guidance. Outcomes will be compared between both groups.
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allied Hospital Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tahir Aslam, Allied Hospital Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791108
- Sponsor's protocol ID
- 48.ERC/FMU/2025-26/339
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Intra-articular Steroid Injection Via Ultrasound Guidance Versus Fluoroscopic Guidance in the Sacroiliac Joint in Patients With Sacroiliitis
- ClinicalTrials.gov ID
- NCT07791108
- Acronym / sponsor ID
- 48.ERC/FMU/2025-26/339
- Conditions
- Sacroiliitis
- Keywords
- Sacroillitis, Triamcinolone
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Allied Hospital FaisalabadUniversity, hospital or other
- Study start
- 27 Sep 2026 (estimated)
- Primary completion
- 27 Nov 2026 (estimated)
- Study completion
- 27 Nov 2026 (estimated)
- First posted
- 27 Aug 2026 (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.
Sacroiliitis is a common cause of low back and buttock pain. Intra-articular steroid injection of the sacroiliac joint can provide pain relief and functional improvement. This randomized controlled trial aims to compare the outcomes of ultrasound-guided versus fluoroscopic-guided sacroiliac joint steroid injections in patients with sacroiliitis. The study will evaluate procedural success, pain reduction, and functional improvement using the Visual Analogue Scale (VAS) and Oswestry Disability Index (ODI) at follow-up intervals.
Detailed description
The sacroiliac joint (SIJ) is increasingly recognized as a contributor to low back pain (LBP), with epidemiological estimates attributing approximately 10-30 % of mechanical low back pain cases to SIJ pathology1. Anatomically, the SIJ is a synovial-type (inferior portion) or syndesmosis-type (superior portion) joint between the sacrum and the ilium, supported by substantial interosseous, posterior and anterior ligaments and innervated by dorsal sacral rami and lower lumbar dorsal rami2. Inflammatory involvement of the SIJ occurs in conditions such as axial spondyloarthritis and may also arise post-traumatically or degeneratively3.
NSAIDs and physical therapies are used to treat sacroiliitis. However, intraarticular corticosteroid injections administered locally to the SI joint might result in rapid and significant clinical improvements in extremely painful instances4,5. Fluoroscope guided (FL) is usually employed to increase the precision of this treatment, however CT and MRI have also been used in recent years. These imaging techniques have a number of drawbacks, such as radiation exposure, expense, and the need for suitable infrastructure6. A new alternative technique for guiding SIJ injection is ultrasound (US) guidance. The advantages of US-guided injection over FL include that it eliminates radiation exposure, is more accessible, and is less expensive when used alone. Additionally, the US permits "real-time" visualisation of the injectate distribution and needle tip during injection.7,8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive intra-articular sacroiliac joint steroid injection either under ultrasound guidance or fluoroscopic guidance. Outcomes will be compared between both groups.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided SI Joint Injection | Experimental | Procedure: Ultrasound-guided intra-articular steroid injectionParticipants will receive sacroiliac joint steroid injection under ultrasound guidance using 40 mg triamcinolone acetonide mixed with 1 mL 0.25% bupivacaine. |
| Fluoroscopic-guided SI Joint Injection | Active comparator | Procedure: Ultrasound-guided intra-articular steroid injectionParticipants will receive sacroiliac joint steroid injection under fluoroscopic guidance with contrast confirmation followed by the same steroid-bupivacaine injection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-70 years
- Both sexes
- Clinical diagnosis of sacroiliitis
Key exclusion criteria (6 listed)
- Prior SI joint injection in the past 12 months
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 |
|---|---|---|
| Ultrasound-guided intra-articular steroid injectionAlso: Ultrasound-guided SI Joint InjectionParticipants will receive intra-articular sacroiliac joint steroid injection under ultrasound guidance. A needle will be advanced under real-time ultrasound guidance to the sacroiliac joint, and 40 mg triamcinolone acetonide mixed with 1 mL 0.25% bupivacaine will be injected. | Procedure or surgery | Fluoroscopic-guided SI Joint Injection, Ultrasound-guided SI Joint Injection |
Primary outcome
Procedural success rate of sacroiliac joint injection
Time frame: During the procedure
Successful intra-articular deposition of steroid in the sacroiliac joint confirmed by the respective imaging guidance modality (ultrasound or fluoroscopy).
1 secondary outcome
Oswestry Disability Index (ODI) Score
Time frame: Baseline, 2 weeks, 1 month, and 3 months after the procedure
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 28 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided intra-articular steroid injection in people with Sacroiliitis, run by Allied Hospital Faisalabad at 1 site in Pakistan.
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 3 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 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Dr.Tahir Aslam Tahir, MBBS, FCPS Orthopedics (+923004499924, tahiraslam398@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success rate of sacroiliac joint injection (time frame: During the procedure). 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 28 Sep 2026.