Success Rate of Ultrasound Guided Sacroiliac Joint Injection in Sacroiliitis

NCT04314609 | Completed DMC

• 1 other identifier: N-161-2018
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Sacroiliitis

Outcome Measures

Primary Outcomes (1)

• 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)

  Immediately after injection

Secondary Outcomes (2)

• Difference in clinical outcome between intraarticular and periarticular injections.

  After 10 minutes, 1 week and 1 month

• Clinical improvement

  After 10 minutes, 1 week ,1 month

Study Arms (1)

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.

Device: Ultrasonography, fluoroscopy

Interventions

Ultrasonography, fluoroscopy DEVICE

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

Ultrasound , fluroscope

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karim Alaaeldin Tawfik: lead

Study Sites (1)

Faculty of medicine cairo university

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Sacroiliitis

Interventions

Ultrasonography; Fluoroscopy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography

Study Officials

• Amany E Ayad, M.D

  Cairo University

  PRINCIPAL INVESTIGATOR

• Ahmed Z Fouad, M.D

  Cairo University

  STUDY CHAIR

• Mohamed A Mansour, M.D

  Cairo University

  STUDY CHAIR

• Karim A Tawfik, MSc

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 19, 2020
• Study Start: October 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 18, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)