Effectiveness of Ultrasound Versus Fluoroscopy Guided S1 Injections and Radiofrequency

NCT ID: NCT05247892

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-10-20

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.

Detailed Description

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Conditions

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Pain, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Fluoroscopic-guided S1 Radiofrequency stimulation

Group Type ACTIVE_COMPARATOR

Fluoroscopic-guided S1 Radiofrequency stimulation

Intervention Type PROCEDURE

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

Ultrasound-guided S1 Radiofrequency stimulation

Group Type EXPERIMENTAL

Ultrasound-guided S1 Radiofrequency stimulation

Intervention Type PROCEDURE

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

Interventions

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Ultrasound-guided S1 Radiofrequency stimulation

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

Intervention Type PROCEDURE

Fluoroscopic-guided S1 Radiofrequency stimulation

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

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Selin Guven Kose

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Diskapi Yildirim Beyazit Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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121/12

Identifier Type: -

Identifier Source: org_study_id

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