Effectiveness of Ultrasound Versus Fluoroscopy Guided S1 Injections and Radiofrequency

Effectiveness of Ultrasound Versus Fluoroscopy Guided S1 Injections and Radiofrequency for the Management of Radicular Pain

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.

Study Overview

• Status: Completed
• Conditions: Pain, Chronic
• Intervention / Treatment: Procedure: Fluoroscopic-guided S1 Radiofrequency stimulation; Procedure: Ultrasound-guided S1 Radiofrequency stimulation

• 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:

• 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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fluoroscopic-guided S1 Radiofrequency stimulation	Procedure: Fluoroscopic-guided S1 Radiofrequency stimulation; Pulsed radiofrequency stimulation of the S1 dorsal root ganglia under fluoroscopy-guidance
Experimental: Ultrasound-guided S1 Radiofrequency stimulation	Procedure: Ultrasound-guided S1 Radiofrequency stimulation; Pulsed radiofrequency stimulation of the S1 dorsal root ganglia under ultrasound-guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	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.	baseline to 6 months post-procedure

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 6 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 6 months post-procedure

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): October 10, 2022
• Study Completion (Actual): October 20, 2022

Study Registration Dates

• First Submitted: February 1, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 31, 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: 121/12

Drug and device information, study documents

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