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Clinical Trials/NCT05247892
NCT05247892
Completed
N/A

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 enrollmentFebruary 1, 2022
ConditionsPain, Chronic

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain, Chronic
Sponsor
Diskapi Teaching and Research Hospital
Enrollment
60
Locations
1
Primary Endpoint
Pain scores
Status
Completed
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2022
End Date
October 20, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Selin Guven Kose

Medical Doctor

Diskapi Teaching and Research Hospital

Eligibility Criteria

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

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)

Study Sites (1)

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