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Clinical Trials/NCT05247892
NCT05247892CompletedNot Applicable

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

Diskapi Teaching and Research Hospital1 site in 1 country60 target enrollmentStarted: February 1, 2022Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Pain scores
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Fluoroscopic-guided S1 Radiofrequency stimulation

Active Comparator

Intervention: Fluoroscopic-guided S1 Radiofrequency stimulation (Procedure)

Ultrasound-guided S1 Radiofrequency stimulation

Experimental

Intervention: Ultrasound-guided S1 Radiofrequency stimulation (Procedure)

Outcomes

Primary Outcomes

Pain scores

Time Frame: 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 Outcomes

  • Oswestry Disability Index (ODI)(baseline to 6 months post-procedure)
  • Patient satisfaction Questionnaire(baseline to 6 months post-procedure)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Selin Guven Kose

Medical Doctor

Diskapi Teaching and Research Hospital

Study Sites (1)

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