CHU NICE
Nice, Alpes Maritimes, 06000, France
Location status: Recruiting
NCT Number: NCT07690449
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Nice, Alpes Maritimes, 06000, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
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).
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).
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.
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.
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire de Nice
Other
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).
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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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