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RecruitingNCT07690449Updated Jul 8, 2026

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.

An observational study in Sciatica, Lumbosacral Radiculopathy and Low Back Pain, sponsored by Centre Hospitalier Universitaire de Nice. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by Centre Hospitalier Universitaire de Nice · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Sciatica
  • Lumbosacral Radiculopathy
  • Low Back Pain
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients referred to the Department of Diagnostic and Interventional Radiology of Pasteur 2 Hospital (Nice) for CT-guided infiltration of low-back sciatica, over the period 30 Jan 2024 to 11 Jul 2024.

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

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
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with low-back sciatica referred for CT-guided infiltration

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

Interventions

  • Diagnostic testPre-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.

05

What researchers measure

Primary outcomes

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

    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).

    Time frame: At inclusion

  2. Prevalence of peri-radicular infiltration on CT

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

    Time frame: At inclusion

  3. Prevalence of spontaneous nerve-root hyperdensity on CT

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

    Time frame: At inclusion

Secondary outcomes

  1. Pre-operative pain (VAS)

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

    Time frame: Before the infiltration (Day 0).

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

    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.

    Time frame: Before the infiltration (Day 0).

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT07690449
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Jul 8, 2026
Start date
Jan 30, 2024
Primary completion
Mar 4, 2026
Completion
Oct 1, 2026 (estimated)
Last update
Jul 8, 2026

Study contacts

kevin desalos
Contact
kevindesalos@gmail.com
06 87 63 05 74 ext. + 33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

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