Faculty of medicine cairo university
Cairo, 11562, Egypt
NCT Number: NCT04314609
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.
Looking for future studies?
Notify Me16 year–80 year
All sexes
Interventional
Not applicable
Cairo, 11562, Egypt
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
success rate of Ultrasound guided SIJ steroid injection confirmed by contrast spread in fluoroscopy
Time frame: Immediately after injection
Percent of successful intraarticular drug injections during USG SIJ steroid injection (as confirmed by contrast spread in fluoroscopy)
Time frame: After 10 minutes, 1 week and 1 month
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 ,1 month
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)
Karim Alaaeldin Tawfik
Other
The Success Rate of Ultrasound Guided Sacroiliac Joint Steroid Injections in Sacroiliitis: Are we Getting Better
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05203926
Arthritis, Joint Diseases
New York, United States
View Trial DetailsNCT03122119
Arthritis, Back Pain
Golden, Colorado, United States
View Trial DetailsNCT02098694
Ankylosis, Arthritis
Ålesund, Norway
View Trial DetailsNCT03834480
Arthritis, Joint Diseases
Al Mansurah, Dakahlia Governorate, Egypt
View Trial Details