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

Not Applicable

Completed

• Conditions: Sacro-Iliac Spondylosis
• Interventions: Device: Sacroiliac joint injection

• Registration Number: NCT04446988
• Lead Sponsor: Minia University

Brief Summary

Sacroiliac joint injection in sacroiliitis

Detailed Description

Comparison of ultrasound guided and fluoroscopic guided sacroiliac joint injection

Study Timeline

• Study Start: 2019-10-15
• Primary Completion: 2020-02-15
• Study Completion: 2020-03-15
• Study First Submitted: 2020-05-19
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-23
• Last Update Submitted: 2020-06-23
• Study First Posted: 2020-06-25
• Last Update Posted: 2020-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluoroscopy(FL)	Sacroiliac joint injection	Sacroiliac joint injection using fluoroscopy
Ultrasound(US)	Sacroiliac joint injection	Sacroiliac joint injection using ultrasound

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ASSIUT University Hospitals; 🇪🇬 Assiut, Egypt