Sacroiliac Joint Somatic DysfunctionNCT05944861
Combination of Fluoroscopy and Ultrasonography Guidance in Sacroiliac Joint Injections. A Randomised Controlled Trial
A study testing Combined ultrasonography and flouroscopy guided injeciton and Flouroscopy guided injection in people with Sacroiliac Joint Somatic Dysfunction and Sacroiliac Joint Pain, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The primary purpose of this study is to investigate the effect of the application of sacroiliac joint injection guided by combination of ultrasonography and fluoroscopy on the duration of the procedure and the amount of radiation exposed during the procedure, compared to the application of only fluoroscopy-guided… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sacroiliac Joint Somatic Dysfunction, Sacroiliac Joint Pain
- What is being tested?
- Combined ultrasonography and flouroscopy guided injeciton and Flouroscopy guided injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2023to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low back and/or gluteal pain and/or groin pain without radicular extension below the L4 level for more than 3 months
- Pain score greater than 3 according to NRS
- Unresponsiveness to conservative treatment (such as exercise, NSAID)
- At least 3 of the five sacroiliac provocation tests (FABER (Patrick), thigh thrust, Gaenslen, sacroiliac compression, and sacroiliac distraction tests) are positive
Who cannot join
- Refusing to participate in the study
- Pregnancy
- Infective sacroiliitis
- Malignancy
- Osteoporosis
- Mechanical lumbosacral pathologies (spondylolisthesis, scoliosis, stenosis, etc.)
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- Neurological finding in the lower extremity
- Pain spreading below the knee
- History of spinal surgery
- History of allergy to drugs to be injected (local anesthetic, contrast material, steroid allergy)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara, Cankaya, 06800
About this study
Official title: Combination of Fluoroscopy and Ultrasonography Guidance in Sacroiliac Joint Injections: Effect on Procedure Time and Radiation Exposure. A Randomised ControlledTrial
The primary purpose of this study is to investigate the effect of the application of sacroiliac joint injection guided by combination of ultrasonography and fluoroscopy on the duration of the procedure and the amount of radiation exposed during the procedure, compared to the application of only fluoroscopy-guided technique. Secondary objectives are to evaluate the effectiveness of the treatment with both methods and to record the adverse events that may be encountered during the procedure.
Read the detailed description
The study was designed as prospective, randomized, controlled trial. The patients who meet the eligibility requirements will be randomized into two groups in a 1:1 ratio to fluoroscopy and ultrasound+fluoroscopy. Processing time will be recorded during injection. "Fluoroscopy time" (sec) and "kerma-area product" (μGy) automatically measured by the fluoroscopy device will be used to evaluate the radiation exposure. Pre-procedural visual analogue scale (VAS) scores and Oswestry Disability Index (ODI) values were noted all the patients.
- Being tested
- Combined ultrasonography and flouroscopy guided injeciton, Flouroscopy guided injection
- Keywords
- Sacroiliac joint pain, Sacroiliac joint injection, Ultrasonography guided injection, Flouroscopy guided injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined ultrasonography and flouroscopy guided injecitonOther
In the ultrasound+fluoroscopy group, the sacroiliac injection will be started under ultrasound guidance. With the help of ultrasound, when sacral 2 foramen is seen the needle will be advanced to the entrance of the sacroiliac joint under real-time in-plane view. After considering intra-articular placement, fluoroscopy guidance will be initiated. An anteroposterior image will be taken to confirm whether contrast material is within the joint. If intra-articular placement is not achieved after contrast medium infiltration, needle reposition will be performed under fluoroscopy for correct needle placement. After the intraarticular contrast pattern is seen, 1 ml of 40 mg methylprednisolone + 1 ml of 1% lidocaine mixture will be injected.
Flouroscopy guided injectionOther
In the fluoroscopy group, the advancement of the needle into the sacroiliac joint will be performed by taking anteroposterior and lateral views. In the same way, the needle tip will be placed in the inferior of the sacroiliac joint, and contrast material distribution examination and injection of the drug will be performed as in the ultrasound + fluoroscopy group.
| Study group | Role | What they receive |
|---|---|---|
| Combined ultrasonography and flouroscopy guided injeciton | Experimental | In 19 patients selected after randomization, the procedure will first be started with ultrasound and then continued with fluoroscopy. Receives: Other: Combined ultrasonography and flouroscopy guided injeciton |
| Flouroscopy guided injection | Active comparator | In 19 patients selected after randomization, the procedure will be performed only through fluoroscopy. Receives: Other: Flouroscopy guided injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Processing Time
The processing time will be measured by the other researcher in the processing room with the help of a stopwatch. The stopwatch will be started when the needle touches the patient and will be stopped when the procedure is finished. It will be recorded in seconds
Measured: during the intervention
Secondary outcomes (4)
Fluoroscopy Time
The fluoroscopy time applied to the patient is automatically measured by the fluoroscopy device. This data will be saved
Measured: during the intervention
Kerma-area Product (μGy)
The kerma area product will be measured to measure the radiation level to which the patient is exposed. This data is automatically measured by the fluoroscopy device.
Measured: during the intervention
Visual Analogue Scale
Severity of pain was assessed using the standard 10 point VAS with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end
Measured: baseline, change from baseline VAS at 1 month after intervention
Oswestry Low Back Pain Disability Questionnaire
The Oswestry disability index will be used to evaluate how much the patients' low back pain limits their activities in daily life. This index was first created in 1980 . The questionnaire consists of 10 sections, each assessing limitations in different daily activities and functions. Each section is scored from 0 to 5. A score of 0 indicates that there is no restriction while doing that activity, while a score of 5 represents the highest level of restriction in that activity. The maximum score is 50. As the total score increases, the disability level of the individual increases. In 2004, Turkish validity study was carried out by Yakut et al.
Measured: baseline, change from baseline VAS at 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start15 Feb 2023
- Primary completion15 Jan 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint Somatic 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
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- Serdar KESIKBURUN, MD, Principal investigator, SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944861
- Sponsor's protocol ID
- 35
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2023
- Last updated
- 11 Mar 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 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Fluoroscopy and Ultrasonography Guidance in Sacroiliac Joint Injections: Effect on Procedure Time and Radiation Exposure. A Randomised ControlledTrial
- ClinicalTrials.gov ID
- NCT05944861
- Acronym / sponsor ID
- 35
- Keywords
- Sacroiliac joint pain, Sacroiliac joint injection, Ultrasonography guided injection, Flouroscopy guided injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 13 Jul 2023 (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.
The primary purpose of this study is to investigate the effect of the application of sacroiliac joint injection guided by combination of ultrasonography and fluoroscopy on the duration of the procedure and the amount of radiation exposed during the procedure, compared to the application of only fluoroscopy-guided technique. Secondary objectives are to evaluate the effectiveness of the treatment with both methods and to record the adverse events that may be encountered during the procedure.
Detailed description
The study was designed as prospective, randomized, controlled trial. The patients who meet the eligibility requirements will be randomized into two groups in a 1:1 ratio to fluoroscopy and ultrasound+fluoroscopy. Processing time will be recorded during injection. "Fluoroscopy time" (sec) and "kerma-area product" (μGy) automatically measured by the fluoroscopy device will be used to evaluate the radiation exposure. Pre-procedural visual analogue scale (VAS) scores and Oswestry Disability Index (ODI) values were noted all the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined ultrasonography and flouroscopy guided injeciton | Experimental | Other: Combined ultrasonography and flouroscopy guided injecitonIn 19 patients selected after randomization, the procedure will first be started with ultrasound and then continued with fluoroscopy. |
| Flouroscopy guided injection | Active comparator | Other: Flouroscopy guided injectionIn 19 patients selected after randomization, the procedure will be performed only through fluoroscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Low back and/or gluteal pain and/or groin pain without radicular extension below the L4 level for more than 3 months
- Pain score greater than 3 according to NRS
- Unresponsiveness to conservative treatment (such as exercise, NSAID)
- At least 3 of the five sacroiliac provocation tests (FABER (Patrick), thigh thrust, Gaenslen, sacroiliac compression, and sacroiliac distraction tests) are positive
Key exclusion criteria (10 listed)
- Refusing to participate in the study
- Pregnancy
- Infective sacroiliitis
- Malignancy
- Osteoporosis
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 |
|---|---|---|
| Combined ultrasonography and flouroscopy guided injecitonIn the ultrasound+fluoroscopy group, the sacroiliac injection will be started under ultrasound guidance. With the help of ultrasound, when sacral 2 foramen is seen the needle will be advanced to the entrance of the sacroiliac joint under real-time in-plane view. After considering intra-articular placement, fluoroscopy guidance will be initiated. An anteroposterior image will be taken to confirm whether contrast material is within the joint. If intra-articular placement is not achieved after contrast medium infiltration, needle reposition will be performed under fluoroscopy for correct needle placement. After the intraarticular contrast pattern is seen, 1 ml of 40 mg methylprednisolone + 1 ml of 1% lidocaine mixture will be injected. | Other | Combined ultrasonography and flouroscopy guided injeciton |
| Flouroscopy guided injectionIn the fluoroscopy group, the advancement of the needle into the sacroiliac joint will be performed by taking anteroposterior and lateral views. In the same way, the needle tip will be placed in the inferior of the sacroiliac joint, and contrast material distribution examination and injection of the drug will be performed as in the ultrasound + fluoroscopy group. | Other | Flouroscopy guided injection |
Primary outcome
Processing Time
Time frame: during the intervention
The processing time will be measured by the other researcher in the processing room with the help of a stopwatch. The stopwatch will be started when the needle touches the patient and will be stopped when the procedure is finished. It will be recorded in seconds
4 secondary outcomes
Fluoroscopy Time
Time frame: during the intervention
Kerma-area Product (μGy)
Time frame: during the intervention
Visual Analogue Scale
Time frame: baseline, change from baseline VAS at 1 month after intervention
Oswestry Low Back Pain Disability Questionnaire
Time frame: baseline, change from baseline VAS at 1 month after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Sacroiliac Joint Somatic Dysfunction
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Active, not recruiting
Sacroiliac Joint Fusion Versus Sham Operation for Treatment of Sacroiliac Joint Pain
Sacroiliac Joint Somatic Dysfunction
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. This study is not recruiting at the moment.
Serdar KESIKBURUN, MD principal investigator
SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined ultrasonography and flouroscopy guided injeciton and Flouroscopy guided injection in people with Sacroiliac Joint Somatic Dysfunction and Sacroiliac Joint Pain, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
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 10 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: finished, as of the sponsor's last update on 11 Mar 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Processing Time (time frame: during the intervention). 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 11 Mar 2026.