Clinical trial NCT03102970: Pain Assessment in Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbations.
Official title: Morpho-COPD1b : Pain Assessment in Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbations.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, Pain, Exacerbation
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to emergency department for acute episodes of exacerbation of chronic obstructive pulmonary disease

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).

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.

Eligibility 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

Primary outcomes:
measure: Variation of the short-form McGill Pain Questionnaire (SF-MPQ) between the exacerbation and the stable phase at 30 days
timeFrame: 30 days after exacerbation
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Emergency department of Hôpital du Sacré Coeur de Montréal
city: Grenoble
country: France
facility: Emergency Department of university hospital
Study officials:
affiliation: University Hospital, Grenoble
name: Maxime MAIGNAN
role: PRINCIPAL_INVESTIGATOR
References: