Fluoroscopic vs Ultrasound Guided Sacroiliac (SI) Joint Injection

The investigators aimed to evaluate the effectiveness of intra-articular sacroiliac joint injection under fluoroscopy versus ultrasound guidance

Study Overview

• Status: Completed
• Conditions: Pain, Chronic
• Intervention / Treatment: Procedure: Flouroscopy-guided sacroiliac joint injection; Procedure: Ultrasound-guided sacroiliac joint injection

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06110
    • Diskapi Yildirim Beyazit Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Low back and/or gluteal pain without radicular extension for more than 3 months
• Tenderness over the SI joint
• Pain score > 3 by Visual Analogue Scale

Exclusion Criteria:

• Malignancy
• Generalized or local infection
• Coagulopathy
• Allergy to drugs to be injected

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluoroscopic-guided sacroiliac joint injection	Procedure: Flouroscopy-guided sacroiliac joint injection; Using anterior posterior and contralateral oblique view the posterior joint line and inferior joint margin were identified and a needle was advanced at the point the posterior inferior joint line was most clearly seen.
Active Comparator: Ultrasound-guided sacroiliac joint injection	Procedure: Ultrasound-guided sacroiliac joint injection; Using ultrasound the sacral hiatus in transverse position was identified. Then, sliding laterally and cephalad in transverse position, the posterior superior iliac spine and the posterior sacroiliac joint were identified. The needle was advanced toward the posterior joint space from medial to lateral, using an in-plane technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in pain	Pain assessment will be performed using the Visual Analogue Scale (VAS) score (0 = no pain, 10 = the most severe pain felt).	Change from baseline pain score at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI)	Mean Change from Baseline in functional disability scores based on Oswestry Disability Index. 0% to 20% indicate minimal disability, 21% to 40% indicate moderate disability, 41%-60% indicates severe disability, 61%-80% means crippled and 81%-100% indicates that the patient is either bed-bound or exaggerating his/her symptoms.	Baseline to 3 months post-procedure
Patient satisfaction Questionnaire	Satisfaction was measured on a 1 to 5 scale,Using score: 5-Excellent, 4-Very Good, 3-Good, 2-Fair, and 1-Poor	baseline to 3 months post-procedure
Quantitative analgesic questionnaire	A tool designed to record patient-reported pain medication use, create scores to quantify and compare it and track changes in analgesic drug use over time. A higher score indicates higher pain medication use	at 3 months post-procedure
Procedure time	Procedure time was measured using a stopwatch. It was defined as the time from the start of the procedure, the initial image was obtained or first probe placement, until the end of the procedure defined as;transforaminal needle placement was seen clearly.	Intraoperative

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 15, 2022

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 126/05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No