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.

NCT07690449 | Recruiting

• 1 other identifier: 26RadioInterv01
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sciatica; Lumbosacral Radiculopathy; Low Back Pain

Outcome Measures

Primary Outcomes (3)

• 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).

  At inclusion

• 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).

  At inclusion

• 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).

  At inclusion

Secondary Outcomes (2)

• Pre-operative pain (VAS)

  Before the infiltration (Day 0).

• Pre-operative quality of life (EQ-5D)

  Before the infiltration (Day 0).

Study Arms (1)

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU NICE

Nice, Alpes Maritimes, 06000, France

RECRUITING

MeSH Terms

Conditions

Sciatica; Low Back Pain

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Central Study Contacts

kevin desalos

CONTACT

06 87 63 05 74; kevindesalos@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: January 30, 2024
• Primary Completion: March 4, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-06

Locations

FR (1)