Ultrasound Versus Fluoroscopic Guided Sacroiliac Joint Injection In Patients With Chronic Sacroiliac Joint Pain

June 23, 2020 updated by: DR. Abd El-Raheem Mahmoud, Minia University
Sacroiliac joint injection in sacroiliitis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Comparison of ultrasound guided and fluoroscopic guided sacroiliac joint injection

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 1225
        • Assiut university hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of sacroiliitis.
  • At least 3 positive physical examination maneuvers [FABER (flexion, abduction, and external rotation), POSH (posterior shear), REAB (resisted abduction), Fortin's finger test],
  • Moderate to severe pain (NRS pain score ≥ 3/10) refractory to oral anti-inflammatory.
  • Age from 18ys to 60ys.

Exclusion Criteria:

  • Ages less than 18 or more than 85 years.
  • Body Mass Index (BMI) above 35 kg/m2.
  • A diagnosis of severe anxiety or depression and other psychological disorders.
  • Allergy to local anesthetics or steroids and pregnancy.
  • Multiple comorbidities (renal , hepatic, cardiac).
  • Coagulation disorder as bleeding tendency and platelet dysfunction.
  • Contraindication for prone position or radiological exposure.
  • Patient refuse .
  • Pain suggestive of bilateral sacroiliac joint involvement (it would have been difficult to assess pain and disability secondary to each SIJ).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound(US)
Sacroiliac joint injection using ultrasound
Device: Sacroiliac joint injection
Injection of sacroiliac joint with local anesthetic and steroid
Experimental: Fluoroscopy(FL)
Sacroiliac joint injection using fluoroscopy
Device: Sacroiliac joint injection
Injection of sacroiliac joint with local anesthetic and steroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale (NRS) pain scores
Time Frame: 3 months
It measures pain intensity (0 no pain - 10 worst pain imaginable)
3 months
Oswestry disability index score
Time Frame: 1 month
It evaluates the physical function (0% minimal disability - 100% bed - bound patient)
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic requirement
Time Frame: 1 month
It shows if the patient needs analgesic or not compared to pretreatment (type and dose in mg)
1 month
Patient satisfaction ( global perceived effect on a 7-point scale (GPE) )
Time Frame: 3 months
It shows if the patient satisfied with the procedure or not (1= worst ever - 7= best ever)
3 months
Procedure time
Time Frame: Procedure
It measures the seconds of procedure in both groups
Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

  • Principal Investigator: Hany Ka Mickhael, Ass. pr., Minia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2019

Primary Completion (Actual)

February 15, 2020

Study Completion (Actual)

March 15, 2020

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

June 23, 2020

First Posted (Actual)

June 25, 2020

Study Record Updates

Last Update Posted (Actual)

June 25, 2020

Last Update Submitted That Met QC Criteria

June 23, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14102019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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