SacroiliitisNCT04314609
Success Rate of Ultrasound Guided Sacroiliac Joint Injection in Sacroiliitis
A study testing Ultrasonography, fluoroscopy in people with Sacroiliitis, run by Karim Alaaeldin Tawfik at 1 site in Egypt.
Trial summary
To re-investigate the success rate of Ultrasound guided sacroiliac joint steroid injection in depositing the drug inside the joint capsule (confirmed by contrast spread in fluoroscopy) and if there is a difference in clinical outcome between injections done strictly inside the joint and injections done periarticular. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Sacroiliitis
- What is being tested?
- Ultrasonography, fluoroscopy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 1 Jun 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject has sacroiliitis (acute or chronic) by history.
- Failed conservative therapy eg. bed rest, anti-inflammatory medications and physical therapy for at least 6 weeks.
Who cannot join
- Subject has BMI above 35 kg/m2
- Coagulopathy.
- Renal or Hepatic Failure.
- Current Pregnancy or actively pursuing pregnancy.
- Known allergy to local anesthetic or steroids.
- Infection at site of needle placement or SIJ infection.
- Prior surgical procedures involving the SIJ.
- Previous surgical Fixation involving the lumbar spine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Success Rate of Ultrasound Guided Sacroiliac Joint Steroid Injections in Sacroiliitis: Are we Getting Better
To re-investigate the success rate of Ultrasound guided sacroiliac joint steroid injection in depositing the drug inside the joint capsule (confirmed by contrast spread in fluoroscopy) and if there is a difference in clinical outcome between injections done strictly inside the joint and injections done periarticular.
Read the detailed description
An IV cannula will be inserted, and basic ASA monitors applied, then the patients will be positioned in prone position. After disinfection of the skin, Ultra sonography will be used to Guide Needle Placement in SIJ (the hypoechoic cleft between the surface of the sacrum and the ilium) under complete a sepsis as the technique previously described in the literature.
A low frequency (2-5 Hz) curvilinear transducer will be used in a sterile cover, the posterior superior iliac spine, lateral borderof sacrum, and ilium will be identified in transverse orientation. Subsequently, the probe will be moved caudally until the superior part of the posterior SIJ is identified. The SIJ will be traced caudally until the distal third of the SIJ is visualized as evident by the flat contour of the iliac crest and the presence of the second sacral foramen on the medial aspect of the sacrum.
After local anesthetic infiltration of skin and subcutaneous tissues using Lidocaine 1%, a 21-gauge spinal needle will be advanced from a medial to lateral direction using an in-plane technique. After reaching the joint, a total volume of 4 ml of injectate will be injected which consists of: 1 ml 40 mg of methylprednisoloneacetate (Depo-Medrol®, Pfizer), 2 ml Lidocaine 2%, 1 ml Iohexol (Omnipaque 300®, GE Healthcare).
Control fluoroscopy
After injection of the drug and withdrawal of the needle, a antero-posterior fluoroscopy image will be obtained and recorded for the injected joint to detect the spread pattern of the contrast and whether its pre-dominantly intra or periarticular. (N.B: Periarticular injection is any injection done near the joint as evidenced by US but on fluoroscopy no contrast is detected inside the joint). Then a sterile patch will be applied to the puncture site and patient discharged to the recovery room for follow-up for 30 minutes before discharge to home.
Measurement tools
- Total number of intraarticular and periarticular drug injections as evidenced by contrast spread in fluoroscopy.
- Patient's pain score rated from 0-10 (Numeric Pain Rating Scale, NRS) before the procedure, 10 minutes after the procedure (in the recovery room), 1 week and 1 month post-procedure.
- Demographic data (including age, sex, BMI, ASA score).
- Limitation of physical functioning as measured by the Oswestry Disability Index (ODI) at 1 month after the procedure .
- Procedure-related variables (time, complications, patient satisfaction.
- Conditions
- Sacroiliitis
- Being tested
- Ultrasonography, fluoroscopy
- Medical subject headings
- Sacroiliitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography, fluoroscopyDevice
success rate of Ultrasound guided SIJ steroid injection confirmed by contrast spread in fluoroscopy
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound , fluroscope | Experimental | After injection of corticosteroids with 1 ml contrast in sacroiliac joint using ultrasound and withdrawal of the needle, an antero-posterior fluoroscopy image will be obtained and recorded for the injected joint to detect the spread pattern of the contrast and whether its pre-dominantly intra or periarticular. Receives: Device: Ultrasonography, fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of ultrasound sacroiliac joint injection
Percent of successful intraarticular drug injections during USG SIJ steroid injection (as confirmed by contrast spread in fluoroscopy)
Measured: Immediately after injection
Secondary outcomes (2)
Difference in clinical outcome between intraarticular and periarticular injections.
Difference in clinical outcome between intraarticular and periarticular injections (confirmed via fluroscopy) as measured clinically by numerical pain score (NPS is a scale from 0 to 10. 0 is no pain and 10 is the maximum pain)
Measured: After 10 minutes, 1 week and 1 month
Clinical improvement
Pain score at 10 minutes , 1 week and 1 month after intervention by numerical pain score (NPS is a scale from 0 to 10. 0 is no pain and 10 is the maximum pain)
Measured: After 10 minutes, 1 week ,1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start1 Oct 2019
- Primary completion1 May 2020
- Study completion1 Jun 2020
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karim Alaaeldin Tawfik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karim Alaaeldin Tawfik, Cairo University
- Investigators
- Amany E Ayad, M.D, Principal investigator, Cairo UniversityAhmed Z Fouad, M.D, Study chair, Cairo UniversityMohamed A Mansour, M.D, Study chair, Cairo UniversityKarim A Tawfik, MSc, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314609
- Sponsor's protocol ID
- N-161-2018
- Status last verified
- Jun 2020
- First submitted
- 17 Mar 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Success Rate of Ultrasound Guided Sacroiliac Joint Steroid Injections in Sacroiliitis: Are we Getting Better
- ClinicalTrials.gov ID
- NCT04314609
- Acronym / sponsor ID
- N-161-2018
- Conditions
- Sacroiliitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Karim Alaaeldin TawfikUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 19 Mar 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.
To re-investigate the success rate of Ultrasound guided sacroiliac joint steroid injection in depositing the drug inside the joint capsule (confirmed by contrast spread in fluoroscopy) and if there is a difference in clinical outcome between injections done strictly inside the joint and injections done periarticular.
Detailed description
An IV cannula will be inserted, and basic ASA monitors applied, then the patients will be positioned in prone position. After disinfection of the skin, Ultra sonography will be used to Guide Needle Placement in SIJ (the hypoechoic cleft between the surface of the sacrum and the ilium) under complete a sepsis as the technique previously described in the literature.
A low frequency (2-5 Hz) curvilinear transducer will be used in a sterile cover, the posterior superior iliac spine, lateral borderof sacrum, and ilium will be identified in transverse orientation. Subsequently, the probe will be moved caudally until the superior part of the posterior SIJ is identified. The SIJ will be traced caudally until the distal third of the SIJ is visualized as evident by the flat contour of the iliac crest and the presence of the second sacral foramen on the medial aspect of the sacrum.
After local anesthetic infiltration of skin and subcutaneous tissues using Lidocaine 1%, a 21-gauge spinal needle will be advanced from a medial to lateral direction using an in-plane technique. After reaching the joint, a total volume of 4 ml of injectate will be injected which consists of: 1 ml 40 mg of methylprednisoloneacetate (Depo-Medrol®, Pfizer), 2 ml Lidocaine 2%, 1 ml Iohexol (Omnipaque 300®, GE Healthcare).
Control fluoroscopy
After injection of the drug and withdrawal of the needle, a antero-posterior fluoroscopy image will be obtained and recorded for the injected joint to detect the spread pattern of the contrast and whether its pre-dominantly intra or periarticular. (N.B: Periarticular injection is any injection done near the joint as evidenced by US but on fluoroscopy no contrast is detected inside the joint). Then a sterile patch will be applied to the puncture site and patient discharged to the recovery room for follow-up for 30 minutes before discharge to home.
Measurement tools
- Total number of intraarticular and periarticular drug injections as evidenced by contrast spread in fluoroscopy.
- Patient's pain score rated from 0-10 (Numeric Pain Rating Scale, NRS) before the procedure, 10 minutes after the procedure (in the recovery room), 1 week and 1 month post-procedure.
- Demographic data (including age, sex, BMI, ASA score).
- Limitation of physical functioning as measured by the Oswestry Disability Index (ODI) at 1 month after the procedure .
- Procedure-related variables (time, complications, patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound , fluroscope | Experimental | Device: Ultrasonography, fluoroscopyAfter injection of corticosteroids with 1 ml contrast in sacroiliac joint using ultrasound and withdrawal of the needle, an antero-posterior fluoroscopy image will be obtained and recorded for the injected joint to detect the spread pattern of the contrast and whether its pre-dominantly intra or periarticular. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has sacroiliitis (acute or chronic) by history.
- Failed conservative therapy eg. bed rest, anti-inflammatory medications and physical therapy for at least 6 weeks.
Key exclusion criteria (8 listed)
- Subject has BMI above 35 kg/m2
- Coagulopathy.
- Renal or Hepatic Failure.
- Current Pregnancy or actively pursuing pregnancy.
- Known allergy to local anesthetic or steroids.
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 |
|---|---|---|
| Ultrasonography, fluoroscopysuccess rate of Ultrasound guided SIJ steroid injection confirmed by contrast spread in fluoroscopy | Device | Ultrasound , fluroscope |
Primary outcome
success rate of ultrasound sacroiliac joint injection
Time frame: Immediately after injection
Percent of successful intraarticular drug injections during USG SIJ steroid injection (as confirmed by contrast spread in fluoroscopy)
2 secondary outcomes
Difference in clinical outcome between intraarticular and periarticular injections.
Time frame: After 10 minutes, 1 week and 1 month
Clinical improvement
Time frame: After 10 minutes, 1 week ,1 month
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 18 Jun 2020.
- 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. This study is not recruiting at the moment.
Amany E Ayad, M.D principal investigator
Cairo University
Ahmed Z Fouad, M.D study chair
Cairo University
Mohamed A Mansour, M.D study chair
Cairo 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 Ultrasonography, fluoroscopy in people with Sacroiliitis, run by Karim Alaaeldin Tawfik 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 2 inclusion and 8 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 18 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?
success rate of ultrasound sacroiliac joint injection (time frame: Immediately 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 18 Jun 2020.