Success Rate of Ultrasound Guided Sacroiliac Joint Injection in

Status Completed

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Sacroiliitis

Clinical Trial Details

NCT number	NCT04314609
Study type	Interventional
Source	Cairo University
Contact
Status	Completed
Phase	N/A
Start date	October 1, 2019
Completion date	June 1, 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Success Rate of Ultrasound Guided Sacroiliac Joint Injection in Sacroiliitis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms