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OpenTrials
Completed

NCT Number: NCT04314609

Success Rate of Ultrasound Guided Sacroiliac Joint Injection in Sacroiliitis

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.

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Key information

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine cairo university

Cairo, 11562, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasonography, fluoroscopy

Device

success rate of Ultrasound guided SIJ steroid injection confirmed by contrast spread in fluoroscopy

Primary outcomes

  1. 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)

Secondary outcomes

  1. Difference in clinical outcome between intraarticular and periarticular injections.

    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)

  2. Clinical improvement

    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)

Sponsors and collaborators

Lead sponsor

Karim Alaaeldin Tawfik

Other

Registry information

Official study title

The Success Rate of Ultrasound Guided Sacroiliac Joint Steroid Injections in Sacroiliitis: Are we Getting Better

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 19, 2020
Registry last updated
Jun 18, 2020

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.

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