Fluoroscopic vs Ultrasound Guided Sacroiliac (SI) Joint Injection

Pain, Chronic Clinical Trial

Official title:

Fluoroscopic vs Ultrasound Guided Sacroiliac (SI) Joint Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05235295
• Other study ID #: 126/05
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: October 15, 2022

Study information

• Verified date: October 2022
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 15, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Diskapi Yildirim Beyazit Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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