CarotidyniaRetroTIPICNCT03690882
Medical Imaging Characteristics of Patient With Unclassified Acute Cervical Pain
An observational study of Carotidynia, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotidynia
- What is being tested?
- systematic review of medical imaging
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2015to 1 Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 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.
Who may be able to join
- 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
Who cannot join
- Musculoskeletal cause of the pain
- Carotid dissection
- Carotid occlusion
- Carotid vasculitis
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Carotidynia
- Being tested
- systematic review of medical imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systematic review of medical imagingOther
| Study group | Role | What they receive |
|---|---|---|
| Cases of unclassified acute cervical pain | Not described Receives: Other: systematic review of medical imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of cases with perivascular inflammation of the carotid on medical imaging
Measured: Within 2 weeks after the first consultation for acute cervical pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start1 Nov 2015
- Primary completion1 Mar 2016
- Study completion1 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarotidyniaStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690882
- Sponsor's protocol ID
- CE_20151117_21_ALR
- Acronym
- RetroTIPIC
- Status last verified
- Sep 2018
- First submitted
- 26 Sep 2018
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Imaging Characteristics of Patient With Unclassified Acute Cervical Pain
- ClinicalTrials.gov ID
- NCT03690882
- Acronym / sponsor ID
- RetroTIPIC / CE_20151117_21_ALR
- Conditions
- Carotidynia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Mar 2016 (actual)
- First posted
- 1 Oct 2018 (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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases of unclassified acute cervical pain | – | Other: systematic review of medical imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Musculoskeletal cause of the pain
- Carotid dissection
- Carotid occlusion
- Carotid vasculitis
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 |
|---|---|---|
| systematic review of medical imaging | Other | Cases of unclassified acute cervical pain |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Carotidynia, run by Fondation Ophtalmologique Adolphe de Rothschild 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: finished, as of the sponsor's last update on 1 Oct 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 1 Oct 2018.