Fluoroscopic vs Ultrasound Guided Sacroiliac (SI) Joint Injection

Not Applicable

Completed

• Conditions: Pain, Chronic

• Registration Number: NCT05235295
• Lead Sponsor: Diskapi Teaching and Research Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-02
• Study First Submitted QC: 2022-02-02
• Study First Posted: 2022-02-11
• Study Start: 2022-04-01
• Status Verified: 2022-10
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-15
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	Baseline to 3 months post-procedure	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.
Quantitative analgesic questionnaire	at 3 months post-procedure	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
Patient satisfaction Questionnaire	baseline to 3 months post-procedure	Satisfaction was measured on a 1 to 5 scale,Using score: 5-Excellent, 4-Very Good, 3-Good, 2-Fair, and 1-Poor
Procedure time	Intraoperative	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.

Trial Locations

Locations (1)

Diskapi Yildirim Beyazit Training and Research Hospital; 🇹🇷 Ankara, Turkey