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

Morpho-COPD1b : Pain Assessment in Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbations.

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).

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Canada
  • Montreal, Canada
    • Emergency department of Hôpital du Sacré Coeur de Montréal
• France
  • Grenoble, France, 38043
    • Emergency Department of university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to emergency department for acute episodes of exacerbation of chronic obstructive pulmonary disease

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation of the short-form McGill Pain Questionnaire (SF-MPQ) between the exacerbation and the stable phase at 30 days	McGill Pain Questionnaire (SF-MPQ)	30 days after exacerbation

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Maxime MAIGNAN, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): April 5, 2018
• Study Completion (Actual): April 5, 2018

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (Actual): April 6, 2017

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: June 4, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: COPD, Pain, Exacerbation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 38RC15.324; DR-2016-269 (Other Identifier: CNIL)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No