Epidemiology of Patients Consulting for Original LBP Spin... | NCT03154554

Studies
Epidemiology of Patients Consulting for Original LBP Spinal Adult Emergency

NCT03154554

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

May 16, 2017Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Lumbar Pain

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2017Estimated

Primary Completion Date

Jun 2017Estimated

Completion Date

Jun 2018Estimated

First Submitted Date

May 11, 2017

First Submission Date that Met QC Criteria

May 12, 2017

First Posted Date

May 16, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2017

Last Update Posted Date

May 16, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Lumbar pain is an extremely common complaint in general population. The direct and indirect costs incurred in are a real public health problem.

Cohort studies show that improving symptoms after consultation for lumbar pain is insufficient, but there are few data on emergency medical and surgical services in France. In order to reflect on areas for improvement the investigators to carry out an inventory of consultations for lumbar pain emergencies of Hautepierre Hospital.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
current clinical condition, lumbar antecedent and patient care questionnaires	The initial questionnaire focuses on the current clinical condition of the patient and his or her lumbar antecedent. The 3-month follow-up questionnaire focuses on the patient care during this period.	At the time of consultation in the adult emergency department, 3 months after consultation in the adult emergency department

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients admitted to adult emergencies in Hautepierre for lumbago pain, with or without sciatica,
Age greater than or equal to 18 years
Having signed non-opposition to participation in the study
Having completed the initial questionnaire

Exclusion criteria:

Spinal trauma in the month before the consultation
Pain of non-spinal origin (pyelonephritis, colic Nephritic, aortic dissection ...)
Non-Francophone Patients
Patient under tutorship or under curatorship
Patient under safeguard of justice

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients admitted to adult emergencies in Hautepierre for lumbago pain, with or without sciatica,

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Etienne QUOIRIN, MD	Contact	33 3 88 12 86 52		etienne.quoirin@chru-strasbourg.fr
Lauriane KURTZ, MD	Contact	33 3 88 12 86 52		lauriane.kurtz@etu.unistra.fr

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided