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OpenTrials
Completed

NCT Number: NCT05247892

Effectiveness of Ultrasound Versus Fluoroscopy Guided S1 Injections and Radiofrequency

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.

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Key information

Conditions

Pain, Chronic Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diskapi Yildirim Beyazit Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound-guided S1 Radiofrequency stimulation

Procedure

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

Fluoroscopic-guided S1 Radiofrequency stimulation

Procedure

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

Primary outcomes

  1. 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

  1. Oswestry Disability Index (ODI)

    Time frame: 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.

  2. Patient satisfaction Questionnaire

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Diskapi Teaching and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 21, 2022
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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