Cervicobrachial Neuralgia and Sagital Balance of the Cervical Spine (CNSBS-NCBES)

January 11, 2018 updated by: Centre Hospitalier Universitaire de Besancon
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

132

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

  • France
      • Besancon, France, 25000
        • Recruiting
        • HAMDAN
        • Contact:
          • Noor HAMDAN

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients suffering of cervicobrachial neuralgia in the hospital of BESANCON, FRANCE followed by a neurosurgeon.

Description

Inclusion Criteria:

  • Adults (>18 years old)
  • Suffering of cervicobrachial neuralgia caused by cervical hernia on MRI diagnosed by a neurosurgeon
  • with social care rights

Exclusion Criteria:

  • Post traumatic cervicobrachial neuralgia in the past 12 months
  • Anteriority of spine surgery
  • Pregnant patients

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: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NDI
Time Frame: Day 1
Pain questionnaires (score of 0 and 50)
Day 1

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Besancon

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)

January 1, 2015

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

December 21, 2017

First Submitted That Met QC Criteria

January 11, 2018

First Posted (Actual)

January 12, 2018

Study Record Updates

Last Update Posted (Actual)

January 12, 2018

Last Update Submitted That Met QC Criteria

January 11, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2016/284

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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