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Recruiting NCT07690449

Three CT Signs of Nerve-root Suffering in Low-back Sciatica: a Study of Their Frequency in Patients Referred for CT-guided Nerve-root Infiltration.

Observational Sciatica Lumbosacral Radiculopathy Low Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pre-infiltration lumbar planning CT scan - reading of the three nerve-root signs.
Who it may be relevant to
Registry conditions: Sciatica, Lumbosacral Radiculopathy, Low Back Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prevalence of Three CT Signs of Nerve-root Suffering (Root Size Asymmetry/Hypertrophy, Peri-radicular Infiltration, Spontaneous Hyperdensity) in Patients With Low-back Sciatica Referred for CT-guided Foraminal Infiltration: a Single-centre Retrospective Study (Nice University Hospital - Pasteur 2).

Overview

Retrospective, observational, single-centre study conducted at Nice University Hospital (Pasteur 2), Department of Diagnostic and Interventional Radiology. Objective: to assess the prevalence of three CT signs sought next to the clinically suspected nerve root in patients with low-back sciatica referred for CT-guided foraminal/peri-radicular infiltration: (1) nerve-root size asymmetry/hypertrophy, (2) peri-radicular infiltration, and (3) spontaneous root hyperdensity. Hypothesis: these signs are associated with the suffering nerve root responsible for the clinical presentation. Pre-infiltration planning CT scans (period 30 Jan 2024 - 11 Jul 2024) are reviewed by the operating radiologists (4th-, 5th- and 6th-year residents). Target enrollment: 400 patients. Data analysed to date: 104 patients / 105 infiltrations. Preliminary prevalence: root asymmetry/hypertrophy 45.5%; peri-radicular infiltration 50.5%; spontaneous hyperdensity 23.8%; at least 2 of 3 signs 38.6%; all 3 signs 16.8%. Mean age 65 years (range 25-93); approximately 62 women / 42 men; predominant levels L4-L5 and L5-S1.

Interventions

  • Diagnostic test Pre-infiltration lumbar planning CT scan - reading of the three nerve-root signs
    Retrospective analysis of the planning CT scans performed before CT-guided foraminal/peri-radicular infiltration. Reading by the operating radiologists (4th-, 5th- and 6th-year radiology residents) assessing, next to the symptomatic nerve root, three signs (present/absent): root size asymmetry/hypertrophy; peri-radicular infiltration; spontaneous hyperdensity. No additional procedure for the patient.

Primary outcome measures

  • Prevalence of nerve-root size asymmetry / hypertrophy on CT [Time frame: At inclusion]
  • Prevalence of peri-radicular infiltration on CT [Time frame: At inclusion]
  • Prevalence of spontaneous nerve-root hyperdensity on CT [Time frame: At inclusion]
Secondary outcome measures (2)
  • Pre-operative pain (VAS) [Time frame: Before the infiltration (Day 0).]
  • Pre-operative quality of life (EQ-5D) [Time frame: Before the infiltration (Day 0).]

Eligibility criteria

Inclusion criteria

  • Adult (>= 18 years)
  • Low-back sciatica / radicular pain with a systematized distribution
  • Referred for CT-guided foraminal or peri-radicular infiltration at Pasteur 2 Hospital (Nice) between 30 Jan 2024 and 11 Jul 2024.
  • Available and interpretable pre-infiltration planning CT

Exclusion criteria

  • Planning CT missing or not interpretable
  • Missing data on the three studied signs
  • Radicular pain of tumoral, infectious or recent traumatic origin
  • Spinal history precluding analysis of the studied root

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • CHU NICE — Nice

Identifiers

NCT: NCT07690449 · 26RadioInterv01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗