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

NCT04446988 | Completed DMC

• 1 other identifier: 14102019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Sacroiliac joint injection in sacroiliitis

Conditions

Sacro-Iliac Spondylosis

Keywords

Sacroiliac

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Analgesic requirement

  1 month

• Patient satisfaction ( global perceived effect on a 7-point scale (GPE) )

  3 months

• Procedure time

  Procedure

Study Arms (2)

Ultrasound(US)

EXPERIMENTAL

Sacroiliac joint injection using ultrasound

Device: Sacroiliac joint injection

Fluoroscopy(FL)

EXPERIMENTAL

Sacroiliac joint injection using fluoroscopy

Device: Sacroiliac joint injection

Interventions

Sacroiliac joint injection DEVICE

Injection of sacroiliac joint with local anesthetic and steroid

Fluoroscopy(FL); Ultrasound(US)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

ASSIUT University Hospitals

Asyut, 1225, Egypt

Location

Related 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.

  PMID: 23193287 RESULT

Study Officials

• Hany Ka Mickhael, Ass. pr.

  Minia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Sacroiliac joint injection with local anesthetic and steroid using ultrasound Versus fluoroscopy in sacroiliitis

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: June 25, 2020
• Study Start: October 15, 2019
• Primary Completion: February 15, 2020
• Study Completion: March 15, 2020
• Last Updated: June 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)