Effectiveness of Ultrasound Versus Fluoroscopy Guided S1 Injections and Radiofrequency

Not Applicable

Completed

• Conditions: Pain, Chronic
• Interventions: Procedure: Fluoroscopic-guided S1 Radiofrequency stimulation; Procedure: Ultrasound-guided S1 Radiofrequency stimulation

• Registration Number: NCT05247892
• Lead Sponsor: Diskapi Teaching and Research Hospital

Brief Summary

The investigators aim to compare the effect of ultrasound versus floroscopy guided pulsed radiofrequency treatment of the lumbar dorsal root ganglion (DRG) of S1 in patients with a chronic lumbosacral radicular pain.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2022-02-01
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-21
• Status Verified: 2022-10
• Primary Completion: 2022-10-10
• Study Completion: 2022-10-20
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

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

Inclusion Criteria

• Persistent pain score ≥ 4 on VAS, not responding to traditional treatments
• Radicular pain in lumbar region for 3 months or more,
• Pattern of radiation suggestive for S1 pathology

Exclusion Criteria

• Patient refusal
• Coagulopathy
• Uncooperative patients
• Malignant disorder or currently under treatment for a malignant disorder
• Pregnancy
• Leg pain due to localized hip or knee pathology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluoroscopic-guided S1 Radiofrequency stimulation	Fluoroscopic-guided S1 Radiofrequency stimulation	-
Ultrasound-guided S1 Radiofrequency stimulation	Ultrasound-guided S1 Radiofrequency stimulation	-

Primary Outcome Measures

Name	Time	Method
Pain scores	baseline to 6 months post-procedure	Visual analog scale (VAS) for pain at the follow-up time periods. The visual analog scale is a numerical scale from 0 to 10; with 0 representing no pain and 10 representing the worst pain imaginable.

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	baseline to 6 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.
Patient satisfaction Questionnaire	baseline to 6 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

Trial Locations

Locations (1)

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