SciaticaNCT07690449
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 of Sciatica and Lumbosacral Radiculopathy, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sciatica, Lumbosacral Radiculopathy, Low Back Pain
- What is being tested?
- Pre-infiltration lumbar planning CT scan - reading of the three nerve-root signs
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2024to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU NICE
Nice, Alpes Maritimes, 06000
kevin desalos, 06 87 63 05 74 ext. + 33, kevindesalos@gmail.com
CHU de Nice, 06 87 63 05 74 ext. +33, kevindesalos@gmail.com
About this study
Official 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).
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
- Being tested
- Pre-infiltration lumbar planning CT scan - reading of the three nerve-root signs
- Medical subject headings
- Sciatica, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-infiltration lumbar planning CT scan - reading of the three nerve-root signsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with low-back sciatica referred for CT-guided infiltration | Not described Receives: Diagnostic Test: Pre-infiltration lumbar planning CT scan - reading of the three nerve-root signs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: At inclusion
Secondary outcomes (2)
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.
Measured: Before the infiltration (Day 0).
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.
Measured: Before the infiltration (Day 0).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start30 Jan 2024
- Primary completion4 Mar 2026
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SciaticaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690449
- Sponsor's protocol ID
- 26RadioInterv01
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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).
- ClinicalTrials.gov ID
- NCT07690449
- Acronym / sponsor ID
- 26RadioInterv01
- Conditions
- Sciatica, Lumbosacral Radiculopathy, Low Back Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 4 Mar 2026 (actual)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-infiltration lumbar planning CT scan - reading of the three nerve-root signsRetrospective 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. | Diagnostic test | Patients with low-back sciatica referred for CT-guided infiltration |
Primary outcome
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).
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).
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).
2 secondary outcomes
Pre-operative pain (VAS)
Time frame: Before the infiltration (Day 0).
Pre-operative quality of life (EQ-5D)
Time frame: Before the infiltration (Day 0).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sciatica and Lumbosacral Radiculopathy, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact kevin desalos (06 87 63 05 74 ext. + 33, kevindesalos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of nerve-root size asymmetry / hypertrophy on CT (time frame: At inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.