About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Case-only
Retrospective
Treatments tested in this trial
Pre-infiltration lumbar planning CT scan - reading of the three nerve-root signs
Diagnostic testRetrospective 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
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).
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).
Secondary outcomes
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.
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.
Sponsors and contacts
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