Pain & Expert: Global Pain-assessment: a Prospective Regi... | NCT04302935

Studies
Pain & Expert: Global Pain-assessment: a Prospective Registry

NCT04302935

Sponsor

Moens Maarten

Status

Unknown status

Last Update Posted

Mar 10, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Chronic Pain

Interventions

Global pain-assessment

Countries

Belgium

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

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2, 2020Actual

Primary Completion Date

Mar 2021Estimated

Completion Date

Mar 2021Estimated

First Submitted Date

Mar 2, 2020

First Submission Date that Met QC Criteria

Mar 6, 2020

First Posted Date

Mar 10, 2020Actual

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

Mar 6, 2020

Last Update Posted Date

Mar 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Week

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
chronic pain patients			Other: Global pain-assessment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Global pain-assessment	Other	Global pain-assessment, based on the ICF framework	chronic pain patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility of a global pain-assessment (i.e. practical use)		at the time of the assessment: one day (cross-sectional)

Secondary Outcomes

Measure	Description	Time Frame
norm values for chronic pain patients on all aspects of the global pain-assessment will be reported (i.e. descriptives)	Reporting of norm values on the different aspects of the ICF framework in patients with chronic pain	at the time of the assessment: one day (cross-sectional)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with chronic pain for at least 3 months
Age => 18 years
Patient has been informed of the study procedures and has given written informed consent

Exclusion Criteria:

Healthy patients or patients with acute pain.
Addiction to drugs, alcohol (>5 units per day)
Evidence of an active disruptive psychiatric disorder that may impact perception of pain, and/or ability to evaluate treatment outcome as determined by investigator
Pregnancy

Accepts Healthy Volunteers

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 with chronic pain.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maarten Moens, prof. dr.	Contact	+32 2 477 55 14		maarten.moens@uzbrussel.be
Lisa Goudman, MSc.	Contact	+32 2 477 55 14

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitair Ziekenhuis Brussel	Recruiting	Jette	Brussels Capital	1090	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D059350	Chronic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided