Cervicobrachial NeuralgiaCNSBS-NCBESNCT03397459
Cervicobrachial Neuralgia and Sagital Balance of the Cervical Spine
An observational study of Cervicobrachial Neuralgia and Lordosis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The aim of this observational study is to establish estimation of global lordosis of the cervical spine (from C3 to C7) in patients with cervicobrachial neuralgia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervicobrachial Neuralgia, Lordosis
- What is being tested?
- Spine teleradiography EOS
- How many people
- 132 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2015to 31 Dec 2018
- 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: Patients suffering of cervicobrachial neuralgia in the hospital of BESANCON, FRANCE followed by a neurosurgeon.
Who may be able to join
- Adults (>18 years old)
- Suffering of cervicobrachial neuralgia caused by cervical hernia on MRI diagnosed by a neurosurgeon
- with social care rights
Who cannot join
- Post traumatic cervicobrachial neuralgia in the past 12 months
- Anteriority of spine surgery
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
Noor HAMDAN contact
About this study
The aim of this observational study is to establish estimation of global lordosis of the cervical spine (from C3 to C7) in patients with cervicobrachial neuralgia.
Read the detailed description
The main judgement critearia is the estimation in degree of this lordosis measured on EOS radiographies, The study includes adults patients with non traumatic cervicobrachial neuralgia caused by discal hernia free from any previous spine surgery.
- Conditions
- Cervicobrachial Neuralgia, Lordosis
- Being tested
- Spine teleradiography EOS
- Keywords
- cervicobrachial neuralgia, sagittal balance, lordosis
- Medical subject headings
- Brachial Plexus Neuritis, Lordosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spine teleradiography EOSDiagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Cervical spine lordosis
In degree, the angle between the lower plate of C2 and the lower plate of the last cervical vertebrea (physiologycally)
Measured: Day 1
Secondary outcomes (1)
NDI
Pain questionnaires (score of 0 and 50)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start1 Jan 2015
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicobrachial NeuralgiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397459
- Sponsor's protocol ID
- P/2016/284
- Acronym
- CNSBS-NCBES
- Status last verified
- Dec 2017
- First submitted
- 21 Dec 2017
- Last updated
- 12 Jan 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 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervicobrachial Neuralgia and Sagital Balance of the Cervical Spine
- ClinicalTrials.gov ID
- NCT03397459
- Acronym / sponsor ID
- CNSBS-NCBES / P/2016/284
- Conditions
- Cervicobrachial Neuralgia, Lordosis
- Keywords
- cervicobrachial neuralgia, sagittal balance, lordosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 12 Jan 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.
The aim of this observational study is to establish estimation of global lordosis of the cervical spine (from C3 to C7) in patients with cervicobrachial neuralgia.
Detailed description
The main judgement critearia is the estimation in degree of this lordosis measured on EOS radiographies, The study includes adults patients with non traumatic cervicobrachial neuralgia caused by discal hernia free from any previous spine surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering of cervicobrachial neuralgia in the hospital of BESANCON, FRANCE followed by a neurosurgeon.
Key inclusion criteria (3 listed)
- Adults (>18 years old)
- Suffering of cervicobrachial neuralgia caused by cervical hernia on MRI diagnosed by a neurosurgeon
- with social care rights
Key exclusion criteria (3 listed)
- Post traumatic cervicobrachial neuralgia in the past 12 months
- Anteriority of spine surgery
- Pregnant patients
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 |
|---|---|---|
| Spine teleradiography EOS | Diagnostic test | – |
Primary outcome
Low Cervical spine lordosis
Time frame: Day 1
In degree, the angle between the lower plate of C2 and the lower plate of the last cervical vertebrea (physiologycally)
1 secondary outcome
NDI
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Noor HAMDAN contact
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 Cervicobrachial Neuralgia and Lordosis, run by Centre Hospitalier Universitaire de Besancon 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noor HAMDAN (hmdnnoor@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low Cervical spine lordosis (time frame: Day 1). 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 12 Jan 2018.