Sacroiliac Joint DysfunctionNCT07881718
Does Injection Target Matter in Sacroiliac Joint Dysfunction?
An observational study of Sacroiliac Joint Dysfunction and Multifidus, run by Fatih Sultan Mehmet Training and Research Hospital.
Trial summary
This retrospective comparative cohort study aims to compare the short-term clinical outcomes of ultrasound-guided sacroiliac joint (SIJ) injection, combined SIJ and multifidus injection, and multifidus injection alone in patients with sacroiliac joint dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sacroiliac Joint Dysfunction, Multifidus, Pain Management
- What is being tested?
- Ultrasound-Guided Sacroiliac Joint Injection and Ultrasound-Guided Multifidus Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 17 Oct 2026to 25 Oct 2026
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of adult patients with chronic low back pain and sacroiliac joint dysfunction who were evaluated at the Physical Medicine and Rehabilitation outpatient clinic between January 1, 2023, and August 15, 2025. Medical records of patients who underwent ultrasound-guided sacroiliac joint and/or multifidus injection as part of routine clinical care were retrospectively reviewed. Eligible patients were classified into three cohorts according to the injection target documented in their medical records: sacroiliac joint injection alone, combined sacroiliac joint and multifidus injection, or multifidus injection alone. No treatment was assigned for research purposes.
Who may be able to join
- Age between 18 and 85 years
- Low back pain lasting for at least 3 months without signs of radiculopathy
- Pain localized over the sacroiliac joint (SIJ) with tenderness on palpation over the SIJ
- Moderate-to-severe pain resistant to oral anti-inflammatory and/or opioid analgesic treatment, defined as a Numerical Rating Scale (NRS) score ≥3/10
- Positive Gillet test together with at least three positive results among five SIJ pain provocation tests (FABER, Gaenslen, distraction, thigh thrust, and compression tests)
Who cannot join
- Coagulopathy
- Systemic infection or skin infection at the injection site
- History of allergy to lidocaine
- Pregnancy
- Obesity, defined as body mass index (BMI) >35 kg/m²
- Multiple comorbidities
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- Diagnosis of severe anxiety or depression
- Spondyloarthritis, psoriasis, inflammatory bowel disease, or signs of peripheral arthritis
- Bilateral SIJ dysfunction, because pain and disability attributable to each joint could not be evaluated separately
About this study
Official title: Does Injection Target Matter in Sacroiliac Joint Dysfunction? A Comparison of Sacroiliac Joint, Multifidus, and Combined Injections
This retrospective comparative cohort study aims to compare the short-term clinical outcomes of ultrasound-guided sacroiliac joint (SIJ) injection, combined SIJ and multifidus injection, and multifidus injection alone in patients with sacroiliac joint dysfunction. Medical records of patients who underwent ultrasound-guided injection procedures were retrospectively reviewed and classified into three groups according to the documented injection target: SIJ injection alone, combined SIJ and multifidus injection, and multifidus injection alone. The primary outcome is the change in pain intensity during movement, assessed using the Visual Analog Scale (VAS) from baseline to 30 minutes after injection. Pain outcomes at one week and changes in functional measures, including the Roland-Morris Disability Questionnaire and Oswestry Disability Index, are evaluated as secondary outcomes. The study aims to determine whether short-term pain and functional outcomes differ according to the injection target.
- Conditions
- Sacroiliac Joint Dysfunction, Multifidus, Pain Management
- Being tested
- Ultrasound-Guided Sacroiliac Joint Injection, Ultrasound-Guided Multifidus Injection
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Sacroiliac Joint InjectionProcedure or surgery
Ultrasound-guided intra-articular sacroiliac joint injection was performed with the patient in the prone position. The sacroiliac joint and surrounding vascular structures were identified using ultrasonography and color Doppler imaging. A 22-gauge, 3.5-inch spinal needle was advanced toward the sacroiliac joint under ultrasound guidance. After confirming the absence of intravascular placement, 2.0 mL of 2% lidocaine was administered intra-articularly.
Ultrasound-Guided Multifidus InjectionProcedure or surgery
Ultrasound-guided intramuscular multifidus injection was performed with the patient in the prone position. After ultrasonographic identification of the relevant sacral anatomical landmarks and the multifidus muscle, a 22-gauge, 3.5-inch spinal needle was advanced into the multifidus muscle under ultrasound guidance. After confirming the absence of intravascular placement, 2.0 mL of 2% lidocaine was administered intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| Sacroiliac Joint Injection Group | Patients with sacroiliac joint dysfunction who received ultrasound-guided intra-articular sacroiliac joint injection alone as part of routine clinical care. A total of 2.0 mL of 2% lidocaine was administered into the sacroiliac joint. Receives: Procedure: Ultrasound-Guided Sacroiliac Joint Injection | |
| Sacroiliac Joint + Multifidus Injection Group | Patients with sacroiliac joint dysfunction who received ultrasound-guided intra-articular sacroiliac joint injection followed by an intramuscular multifidus injection as part of routine clinical care. A total of 2.0 mL of 2% lidocaine was administered to the sacroiliac joint and 2.0 mL of 2% lidocaine was administered to the multifidus muscle. Receives: Procedure: Ultrasound-Guided Sacroiliac Joint Injection; Procedure: Ultrasound-Guided Multifidus Injection | |
| Multifidus Injection Group | Patients with sacroiliac joint dysfunction who received ultrasound-guided intramuscular multifidus injection alone as part of routine clinical care, without entering the sacroiliac joint. A total of 2.0 mL of 2% lidocaine was administered to the multifidus muscle. Receives: Procedure: Ultrasound-Guided Multifidus Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity During Movement Assessed Using the Visual Analog Scale (VAS)
Pain intensity during movement was assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, with 0 indicating no pain and 10 indicating the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome. Changes in Visual Analog Scale scores were evaluated from baseline to 30 minutes and 1 week after the injection.
Measured: Baseline, 30 minutes after injection, and 1 week after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start17 Oct 2026 (estimated)
- Primary completion25 Oct 2026 (estimated)
- Study completion25 Oct 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881718
- Sponsor's protocol ID
- FSMSACROILIAC
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Injection Target Matter in Sacroiliac Joint Dysfunction? A Comparison of Sacroiliac Joint, Multifidus, and Combined Injections
- ClinicalTrials.gov ID
- NCT07881718
- Acronym / sponsor ID
- FSMSACROILIAC
- Conditions
- Sacroiliac Joint Dysfunction, Multifidus, Pain Management
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 17 Oct 2026 (estimated)
- Primary completion
- 25 Oct 2026 (estimated)
- Study completion
- 25 Oct 2026 (estimated)
- First posted
- 19 Oct 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.
This retrospective comparative cohort study aims to compare the short-term clinical outcomes of ultrasound-guided sacroiliac joint (SIJ) injection, combined SIJ and multifidus injection, and multifidus injection alone in patients with sacroiliac joint dysfunction. Medical records of patients who underwent ultrasound-guided injection procedures were retrospectively reviewed and classified into three groups according to the documented injection target: SIJ injection alone, combined SIJ and multifidus injection, and multifidus injection alone. The primary outcome is the change in pain intensity during movement, assessed using the Visual Analog Scale (VAS) from baseline to 30 minutes after injection. Pain outcomes at one week and changes in functional measures, including the Roland-Morris Disability Questionnaire and Oswestry Disability Index, are evaluated as secondary outcomes. The study aims to determine whether short-term pain and functional outcomes differ according to the injection target.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sacroiliac Joint Injection Group | – | Procedure: Ultrasound-Guided Sacroiliac Joint InjectionPatients with sacroiliac joint dysfunction who received ultrasound-guided intra-articular sacroiliac joint injection alone as part of routine clinical care. A total of 2.0 mL of 2% lidocaine was administered into the sacroiliac joint. |
| Sacroiliac Joint + Multifidus Injection Group | – | Procedure: Ultrasound-Guided Sacroiliac Joint Injection, Procedure: Ultrasound-Guided Multifidus InjectionPatients with sacroiliac joint dysfunction who received ultrasound-guided intra-articular sacroiliac joint injection followed by an intramuscular multifidus injection as part of routine clinical care. A total of 2.0 mL of 2% lidocaine was administered to the sacroiliac joint and 2.0 mL of 2% lidocaine was administered to the multifidus muscle. |
| Multifidus Injection Group | – | Procedure: Ultrasound-Guided Multifidus InjectionPatients with sacroiliac joint dysfunction who received ultrasound-guided intramuscular multifidus injection alone as part of routine clinical care, without entering the sacroiliac joint. A total of 2.0 mL of 2% lidocaine was administered to the multifidus muscle. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adult patients with chronic low back pain and sacroiliac joint dysfunction who were evaluated at the Physical Medicine and Rehabilitation outpatient clinic between January 1, 2023, and August 15, 2025. Medical records of patients who underwent ultrasound-guided sacroiliac joint and/or multifidus injection as part of routine clinical care were retrospectively reviewed. Eligible patients were classified into three cohorts according to the injection target documented in their medical records: sacroiliac joint injection alone, combined sacroiliac joint and multifidus injection, or multifidus injection alone. No treatment was assigned for research purposes.
Key inclusion criteria (5 listed)
- Age between 18 and 85 years
- Low back pain lasting for at least 3 months without signs of radiculopathy
- Pain localized over the sacroiliac joint (SIJ) with tenderness on palpation over the SIJ
- Moderate-to-severe pain resistant to oral anti-inflammatory and/or opioid analgesic treatment, defined as a Numerical Rating Scale (NRS) score ≥3/10
- Positive Gillet test together with at least three positive results among five SIJ pain provocation tests (FABER, Gaenslen, distraction, thigh thrust, and compression tests)
Key exclusion criteria (9 listed)
- Coagulopathy
- Systemic infection or skin infection at the injection site
- History of allergy to lidocaine
- Pregnancy
- Obesity, defined as body mass index (BMI) >35 kg/m²
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 Sacroiliac Joint InjectionUltrasound-guided intra-articular sacroiliac joint injection was performed with the patient in the prone position. The sacroiliac joint and surrounding vascular structures were identified using ultrasonography and color Doppler imaging. A 22-gauge, 3.5-inch spinal needle was advanced toward the sacroiliac joint under ultrasound guidance. After confirming the absence of intravascular placement, 2.0 mL of 2% lidocaine was administered intra-articularly. | Procedure or surgery | Sacroiliac Joint + Multifidus Injection Group, Sacroiliac Joint Injection Group |
| Ultrasound-Guided Multifidus InjectionUltrasound-guided intramuscular multifidus injection was performed with the patient in the prone position. After ultrasonographic identification of the relevant sacral anatomical landmarks and the multifidus muscle, a 22-gauge, 3.5-inch spinal needle was advanced into the multifidus muscle under ultrasound guidance. After confirming the absence of intravascular placement, 2.0 mL of 2% lidocaine was administered intramuscularly. | Procedure or surgery | Multifidus Injection Group, Sacroiliac Joint + Multifidus Injection Group |
Primary outcome
Change in Pain Intensity During Movement Assessed Using the Visual Analog Scale (VAS)
Time frame: Baseline, 30 minutes after injection, and 1 week after injection
Pain intensity during movement was assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, with 0 indicating no pain and 10 indicating the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome. Changes in Visual Analog Scale scores were evaluated from baseline to 30 minutes and 1 week after the injection.
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 19 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sacroiliac Joint Dysfunction and Multifidus, run by Fatih Sultan Mehmet Training and Research Hospital.
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 5 inclusion and 9 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 19 Oct 2026. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity During Movement Assessed Using the Visual Analog Scale (VAS) (time frame: Baseline, 30 minutes after injection, and 1 week after injection). 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 19 Oct 2026.