Success Rate of Ultrasound Guided Sacroiliac Joint Injection in Sacroiliitis
Primary Purpose
Sacroiliitis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasonography, fluoroscopy
Sponsored by
About this trial
This is an interventional treatment trial for Sacroiliitis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Faculty of medicine cairo university
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultrasound , fluroscope
Arm Description
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04314609
Brief Title
Success Rate of Ultrasound Guided Sacroiliac Joint Injection in Sacroiliitis
Official Title
The Success Rate of Ultrasound Guided Sacroiliac Joint Steroid Injections in Sacroiliitis: Are we Getting Better
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Karim Alaaeldin Tawfik
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound , fluroscope
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Ultrasonography, fluoroscopy
Intervention Description
success rate of Ultrasound guided SIJ steroid injection confirmed by contrast spread in fluoroscopy
Primary Outcome Measure Information:
Title
success rate of ultrasound sacroiliac joint injection
Description
Percent of successful intraarticular drug injections during USG SIJ steroid injection (as confirmed by contrast spread in fluoroscopy)
Time Frame
Immediately after injection
Secondary Outcome Measure Information:
Title
Difference in clinical outcome between intraarticular and periarticular injections.
Description
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)
Time Frame
After 10 minutes, 1 week and 1 month
Title
Clinical improvement
Description
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)
Time Frame
After 10 minutes, 1 week ,1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amany E Ayad, M.D
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed Z Fouad, M.D
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohamed A Mansour, M.D
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Karim A Tawfik, MSc
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of medicine cairo university
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Success Rate of Ultrasound Guided Sacroiliac Joint Injection in Sacroiliitis
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