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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03397459
Recruitment Status : Unknown
Verified December 2017 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Recruiting
First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Cervicobrachial Neuralgia Lordosis Diagnostic Test: Spine teleradiography EOS

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
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Study Type : Observational
Estimated Enrollment : 132 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cervicobrachial Neuralgia and Sagital Balance of the Cervical Spine
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. NDI [ Time Frame: Day 1 ]
    Pain questionnaires (score of 0 and 50)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering of cervicobrachial neuralgia in the hospital of BESANCON, FRANCE followed by a neurosurgeon.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397459


Contacts
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Contact: Noor HAMDAN hmdnnoor@gmail.com

Locations
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France
HAMDAN Recruiting
Besancon, France, 25000
Contact: Noor HAMDAN         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
More Information
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03397459    
Other Study ID Numbers: P/2016/284
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
cervicobrachial neuralgia
sagittal balance
lordosis
Additional relevant MeSH terms:
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Lordosis
Neuralgia
Brachial Plexus Neuritis
Swayback
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
 Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Deficiency Diseases
Malnutrition
Nutrition Disorders
Brachial Plexus Neuropathies
Neuritis