- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04302935
Pain & Expert: Global Pain-assessment: a Prospective Registry
March 6, 2020 updated by: Moens Maarten
Full assessment of chronic pain patients based on the ICF-model.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
100
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
-
-
Brussel
-
Jette, Brussel, Belgium, 1090
- Recruiting
- Universitair Ziekenhuis Brussel
-
Contact:
- Maarten Moens
-
Contact:
- Lisa Goudman
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with chronic pain.
Description
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
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
chronic pain patients
|
Global pain-assessment, based on the ICF framework
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Feasibility of a global pain-assessment (i.e. practical use)
Time Frame: at the time of the assessment: one day (cross-sectional)
|
at the time of the assessment: one day (cross-sectional)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
norm values for chronic pain patients on all aspects of the global pain-assessment will be reported (i.e. descriptives)
Time Frame: at the time of the assessment: one day (cross-sectional)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 2, 2020
Primary Completion (Anticipated)
March 1, 2021
Study Completion (Anticipated)
March 1, 2021
Study Registration Dates
First Submitted
March 2, 2020
First Submitted That Met QC Criteria
March 6, 2020
First Posted (Actual)
March 10, 2020
Study Record Updates
Last Update Posted (Actual)
March 10, 2020
Last Update Submitted That Met QC Criteria
March 6, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P&E
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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