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NCT Number: 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.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pre-infiltration lumbar planning CT scan - reading of the three nerve-root signs

Diagnostic Test

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 outcomes

  1. Prevalence of nerve-root size asymmetry / hypertrophy on CT

    Time frame: At inclusion

    Proportion of patients showing, on the pre-infiltration planning CT, size asymmetry (hypertrophy) of the nerve root next to the clinically suspected root (present/absent).

  2. Prevalence of peri-radicular infiltration on CT

    Time frame: At inclusion

    Proportion of patients showing, on the pre-infiltration planning CT, infiltration of the peri-radicular tissues next to the clinically suspected root (present/absent).

  3. Prevalence of spontaneous nerve-root hyperdensity on CT

    Time frame: At inclusion

    Proportion of patients showing, on the pre-infiltration planning CT, spontaneous hyperdensity of the nerve root next to the clinically suspected root (present/absent).

Secondary outcomes

  1. Pre-operative pain (VAS)

    Time frame: Before the infiltration (Day 0).

    Visual analogue scale for pain, from 0 (no pain) to 10 (worst imaginable pain); a higher score indicates more severe pain.

  2. Pre-operative quality of life (EQ-5D)

    Time frame: Before the infiltration (Day 0).

    EQ-5D questionnaire covering 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Collected before the infiltration; used as the baseline health-state assessment.

Study contacts

Contact information is provided by the study sponsor or research team.

kevin desalos

CONTACT

[email protected]

06 87 63 05 74 ext. + 33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study 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).

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

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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