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Pain Assessment in Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbations. (MorphoCOPD1b)

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ClinicalTrials.gov Identifier: NCT03102970
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:

The prevalence of chronic obstructive pulmonary disease (COPD) is between 8 and 12% of the adult population. This prevalence is expected to increase over the coming decades due to the aging of the population and the continued exposure to risk factors for the disease. The evolution of COPD is marked by the occurrence of exacerbations of varying severity and patients are frequently admitted to the emergency department for evaluation, treatment and / or hospitalization. Admission in emergency department for COPD exacerbation represents approximately 1% of emergency admission.

Chronic pain is common in patients with Chronic Obstructive Pulmonary Disease (COPD). The pain intensity may increase during acute episodes of exacerbations. This study is aimed to compare pain intensity during exacerbation and stable phase of patients with chronic obstructive pulmonary disease (COPD).


Condition or disease
Chronic Obstructive Pulmonary Disease

Detailed Description:
Chronic pain is common in patients with Chronic Obstructive pulmonary Disease (COPD). The pain intensity may increase during acute episodes of exacerbation. Fifty (50) patients in acute exacerbation of COPD will be included in the emergency department of CHU Grenoble Alpes and Hôpital du Sacré Coeur de Montréal. The intensity and characteristics of pain will be evaluated from the Short-Form McGill Pain Questionnaire (SF-MPQ) and the Brief Pain Inventory (BPI). Assessment of respiratory status, anxiety and depression, and clinical and biological data, defining the severity of exacerbation, will also be collected. A 30-day follow-up visit, after a return to the stable state of COPD, allowed the realization of Respiratory Functional Exploration and the same questionnaires.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Morpho-COPD1b : Pain Assessment in Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbations.
Actual Study Start Date : December 2015
Actual Primary Completion Date : April 5, 2018
Actual Study Completion Date : April 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases




Primary Outcome Measures :
  1. Variation of the short-form McGill Pain Questionnaire (SF-MPQ) between the exacerbation and the stable phase at 30 days [ Time Frame: 30 days after exacerbation ]
    McGill Pain Questionnaire (SF-MPQ)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to emergency department for acute episodes of exacerbation of chronic obstructive pulmonary disease
Criteria

Inclusion Criteria:

  • ≥ 40 years
  • smoking at least ≥ 10 pack years
  • previous FEV / FVC <0.70 post bronchodilator
  • admitted for exacerbations (GOLD definition)

Exclusion Criteria:

  • A dementia or non-communicating patient
  • Patient with chronic pain of neoplastic origin or severe trauma (fracture , dislocation or severe pain) within 15 days before the date of inclusion
  • Patient with no social security insurance , with restricted liberty or under legal protection
  • Pregnant woman parturient or nursing

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): NCT03102970


Locations
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Canada
Emergency department of Hôpital du Sacré Coeur de Montréal
Montreal, Canada
France
Emergency Department of university hospital
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Maxime MAIGNAN University Hospital, Grenoble

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03102970     History of Changes
Other Study ID Numbers: 38RC15.324
DR-2016-269 ( Other Identifier: CNIL )
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: February 2018
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 University Hospital, Grenoble:
COPD, Pain, Exacerbation
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases