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

Sacro-Iliac Spondylosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04446988
• Other study ID #: 14102019
• Status: Completed
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: June 2020
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sacroiliac joint injection in sacroiliitis

Description:

Comparison of ultrasound guided and fluoroscopic guided sacroiliac joint injection

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 15, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Arthralgia
• Sacro-Iliac Spondylosis
• Spondylosis

Intervention

Device:
• Sacroiliac joint injection
Injection of sacroiliac joint with local anesthetic and steroid

Locations

Country	Name	City	State
Egypt	ASSIUT University Hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Benson DA, Cavanaugh M, Clark K, Karsch-Mizrachi I, Lipman DJ, Ostell J, Sayers EW. GenBank. Nucleic Acids Res. 2013 Jan;41(Database issue):D36-42. doi: 10.1093/nar/gks1195. Epub 2012 Nov 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Rating Scale (NRS) pain scores	It measures pain intensity (0 no pain - 10 worst pain imaginable)	3 months
Primary	Oswestry disability index score	It evaluates the physical function (0% minimal disability - 100% bed - bound patient)	1 month
Secondary	Analgesic requirement	It shows if the patient needs analgesic or not compared to pretreatment (type and dose in mg)	1 month
Secondary	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
Secondary	Procedure time	It measures the seconds of procedure in both groups	Procedure

External Links

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