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

Study Overview
=================
Brief Summary
-----------------
Sacroiliac joint injection in sacroiliitis

Detailed Description
-----------------
Comparison of ultrasound guided and fluoroscopic guided sacroiliac joint injection

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

Conditions
-----------------
Sacro-Iliac Spondylosis

Intervention / Treatment
-----------------
* Device: Sacroiliac joint injection


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Sacroiliac joint injection with local anesthetic and steroid using ultrasound Versus fluoroscopy in sacroiliitis
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating Scale (NRS) pain scores | It measures pain intensity (0 no pain - 10 worst pain imaginable) | 3 months | 
| Oswestry disability index score | 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 | 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) ) | It shows if the patient satisfied with the procedure or not (1= worst ever - 7= best ever) | 3 months | 
| Procedure time | It measures the seconds of procedure in both groups | Procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sacroiliac