Effectiveness of Ultrasound Versus Fluoroscopy Guided S1 Injections and Radiofrequency

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Chronic

Intervention / Treatment
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* Procedure: Ultrasound-guided S1 Radiofrequency stimulation
* Procedure: Fluoroscopic-guided S1 Radiofrequency stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 |