Sacro-Iliac SpondylosisNCT04446988
Ultrasound Versus Fluoroscopic Guided Sacroiliac Joint Injection In Patients With Chronic Sacroiliac Joint Pain
A study testing Sacroiliac joint injection in people with Sacro-Iliac Spondylosis, run by Minia University at 1 site in Egypt.
Trial summary
Sacroiliac joint injection in sacroiliitis Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sacro-Iliac Spondylosis
- What is being tested?
- Sacroiliac joint injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2019to 15 Mar 2020
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of sacroiliitis.
- At least 3 positive physical examination maneuvers [FABER (flexion, abduction, and external rotation), POSH (posterior shear), REAB (resisted abduction), Fortin's finger test],
- Moderate to severe pain (NRS pain score ≥ 3/10) refractory to oral anti-inflammatory.
- Age from 18ys to 60ys.
Who cannot join
- Ages less than 18 or more than 85 years.
- Body Mass Index (BMI) above 35 kg/m2.
- A diagnosis of severe anxiety or depression and other psychological disorders.
- Allergy to local anesthetics or steroids and pregnancy.
- Multiple comorbidities (renal , hepatic, cardiac).
- Coagulation disorder as bleeding tendency and platelet dysfunction.
Show all 9Show fewer
- Contraindication for prone position or radiological exposure.
- Patient refuse .
- Pain suggestive of bilateral sacroiliac joint involvement (it would have been difficult to assess pain and disability secondary to each SIJ).
Trial locations and contacts
1 site in 1 country.
About this study
Sacroiliac joint injection in sacroiliitis
Read the detailed description
Comparison of ultrasound guided and fluoroscopic guided sacroiliac joint injection
- Conditions
- Sacro-Iliac Spondylosis
- Being tested
- Sacroiliac joint injection
- Keywords
- Sacroiliac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacroiliac joint injectionDevice
Injection of sacroiliac joint with local anesthetic and steroid
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound(US) | Experimental | Sacroiliac joint injection using ultrasound Receives: Device: Sacroiliac joint injection |
| Fluoroscopy(FL) | Experimental | Sacroiliac joint injection using fluoroscopy Receives: Device: Sacroiliac joint injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS) pain scores
It measures pain intensity (0 no pain - 10 worst pain imaginable)
Measured: 3 months
Oswestry disability index score
It evaluates the physical function (0% minimal disability - 100% bed - bound patient)
Measured: 1 month
Secondary outcomes (3)
Analgesic requirement
It shows if the patient needs analgesic or not compared to pretreatment (type and dose in mg)
Measured: 1 month
Patient satisfaction ( global perceived effect on a 7-point scale (GPE) )
It shows if the patient satisfied with the procedure or not (1= worst ever - 7= best ever)
Measured: 3 months
Procedure time
It measures the seconds of procedure in both groups
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start15 Oct 2019
- Primary completion15 Feb 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sacro-Iliac SpondylosisStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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
- Sacroiliac joint injection with local anesthetic and steroid using ultrasound Versus fluoroscopy in sacroiliitis
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR. Abd El-Raheem Mahmoud, Minia University
- Investigators
- Hany Ka Mickhael, Ass. pr., Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446988
- Sponsor's protocol ID
- 14102019
- Status last verified
- Jun 2020
- First submitted
- 19 May 2020
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benson DA, Cavanaugh M, Clark K, Karsch-Mizrachi I, Lipman DJ, Ostell J, Sayers EW. GenBank. Nucleic Acids Res. 2013 Jan;41(Database issue):D36-42. doi: 10.1093/nar/gks1195. Epub 2012 Nov 27.
PubMed 23193287
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Versus Fluoroscopic Guided Sacroiliac Joint Injection In Patients With Chronic Sacroiliac Joint Pain
- ClinicalTrials.gov ID
- NCT04446988
- Acronym / sponsor ID
- 14102019
- Conditions
- Sacro-Iliac Spondylosis
- Keywords
- Sacroiliac
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 25 Jun 2020 (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.
Sacroiliac joint injection in sacroiliitis
Detailed description
Comparison of ultrasound guided and fluoroscopic guided sacroiliac joint injection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sacroiliac joint injection with local anesthetic and steroid using ultrasound Versus fluoroscopy in sacroiliitis
| Arm | Type | Receives |
|---|---|---|
| Ultrasound(US) | Experimental | Device: Sacroiliac joint injectionSacroiliac joint injection using ultrasound |
| Fluoroscopy(FL) | Experimental | Device: Sacroiliac joint injectionSacroiliac joint injection using fluoroscopy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of sacroiliitis.
- At least 3 positive physical examination maneuvers [FABER (flexion, abduction, and external rotation), POSH (posterior shear), REAB (resisted abduction), Fortin's finger test],
- Moderate to severe pain (NRS pain score ≥ 3/10) refractory to oral anti-inflammatory.
- Age from 18ys to 60ys.
Key exclusion criteria (9 listed)
- Ages less than 18 or more than 85 years.
- Body Mass Index (BMI) above 35 kg/m2.
- A diagnosis of severe anxiety or depression and other psychological disorders.
- Allergy to local anesthetics or steroids and pregnancy.
- Multiple comorbidities (renal , hepatic, cardiac).
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 |
|---|---|---|
| Sacroiliac joint injectionInjection of sacroiliac joint with local anesthetic and steroid | Device | Fluoroscopy(FL), Ultrasound(US) |
Primary outcome
Numeric Rating Scale (NRS) pain scores
Time frame: 3 months
It measures pain intensity (0 no pain - 10 worst pain imaginable)
Oswestry disability index score
Time frame: 1 month
It evaluates the physical function (0% minimal disability - 100% bed - bound patient)
3 secondary outcomes
Analgesic requirement
Time frame: 1 month
Patient satisfaction ( global perceived effect on a 7-point scale (GPE) )
Time frame: 3 months
Procedure time
Time frame: Procedure
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 25 Jun 2020.
- Results publication: PubMed 23193287Benson DA, Cavanaugh M, Clark K, Karsch-Mizrachi I, Lipman DJ, Ostell J, Sayers EW. GenBank. Nucleic Acids Res. 2013 Jan;41(Database issue):D36-42. doi: 10.1093/nar/gks1195. Epub 2012 Nov 27.
- Individual participant dataSharing planned: No
Related trials for Sacro-Iliac Spondylosis
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RecruitingPhase 4
Particulate vs. Non-Particulate Steroid for Sacroiliac Joint Injection
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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. This study is not recruiting at the moment.
Hany Ka Mickhael, Ass. pr. principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacroiliac joint injection in people with Sacro-Iliac Spondylosis, run by Minia University at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 25 Jun 2020. 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 Egypt. 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?
Numeric Rating Scale (NRS) pain scores (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04446988, which also lists 1 linked publication.
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 25 Jun 2020.