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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05247892

Enrollment

Registered

2022-02-21

Start date

2022-02-01

Completion date

2022-10-20

Last updated

2022-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Chronic

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.

Interventions

PROCEDUREUltrasound-guided S1 Radiofrequency stimulation

Pulsed radiofrequency stimulation of the S1 dorsal root ganglia under ultrasound-guidance

PROCEDUREFluoroscopic-guided S1 Radiofrequency stimulation

Pulsed radiofrequency stimulation of the S1 dorsal root ganglia under fluoroscopy-guidance

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026