Effectiveness of Ultrasound Versus Fluoroscopy Guided S1 Injections and Radiofrequency

Pain, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05247892
• Other study ID #: 121/12
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: October 20, 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 20, 2022
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

Procedure:
• Ultrasound-guided S1 Radiofrequency stimulation
Pulsed radiofrequency stimulation of the S1 dorsal root ganglia under ultrasound-guidance
• Fluoroscopic-guided S1 Radiofrequency stimulation
Pulsed radiofrequency stimulation of the S1 dorsal root ganglia under fluoroscopy-guidance

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	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	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
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 6 months post-procedure