Medical Imaging Characteristics of Patient With Unclassified Acute Cervical Pain (RetroTIPIC)

Some cases of acute antero-lateral cervical pain cannot be accurately classified by medical imaging (ultrasound and/or magnetic resonance imaging and/or CT-scan) : imaging rules out carotid dissection, carotid occlusion or vasculitis as well as musculoskeletal causes and thus the pain is considered "of unknown origin".

The investigators hypothesize that in such cases perivascular inflammation of the carotid may be involved.

This study aims at systematically reviewing medical files (including imaging) of patients suffering from acute cervical pain in which carotid dissection, carotid occlusion or vasculitis as well as musculoskeletal causes have been ruled out by ultrasound and/or magnetic resonance imaging and/or CT-scan

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 75019
        • Fondation Ophtalmologique A. de Rotchschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult patients from 10 centers in France, who presented from January 2009 through April 2016 with acute cervical pain and with at least 1 diagnostic image (MR imaging, CT, or US including a dedicated vessel analysis) in which no clearly identified and classified vascular or musculoskeletal cause of the pain was found.

Description

Inclusion Criteria:

  • Adult patient with acute cervical pain
  • Presence of at least one medical imaging modality of the neck : ultrasound with doppler imaging, magnetic resonance imaging, CT-scan
  • Medical imaging of the neck includes dedicated vessel analysis
  • Absence of definite diagnosis for the cause of the pain after imaging

Exclusion Criteria:

  • Musculoskeletal cause of the pain
  • Carotid dissection
  • Carotid occlusion
  • Carotid vasculitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases of unclassified acute cervical pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of cases with perivascular inflammation of the carotid on medical imaging
Time Frame: Within 2 weeks after the first consultation for acute cervical pain
Within 2 weeks after the first consultation for acute cervical pain

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

September 26, 2018

First Submitted That Met QC Criteria

September 28, 2018

First Posted (Actual)

October 1, 2018

Study Record Updates

Last Update Posted (Actual)

October 1, 2018

Last Update Submitted That Met QC Criteria

September 28, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE_20151117_21_ALR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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