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

Not Applicable

Completed

• Conditions: Sacro-Iliac Spondylosis

• 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

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