Brief Title
Pain Mechanisms in Patients With Bronchiectasis
Official Title
Characteristics of Underlying Pain Mechanisms in Patients With Bronchiectasis: a Cross-sectional Study
Brief Summary
Pain mechanisms and their clinical impact in patients with bronchiectasis have not been investigated yet. The aim of the research is to assess the presence of central pain mechanisms in patients with bronchiectasis using the Quantitative Sensory Testing (QST) assumptions.
Detailed Description
Background and objective: Recent findings suggest that pain can play an important role in terms of physical activity limitation in respiratory patients. Nevertheless, pain mechanisms and their clinical impact in patients with bronchiectasis have not been investigated yet. The objective of the observational study is to determine the somatosensorial profile in order to assess the presence of central pain mechanisms in patients with bronchiectasis. Methodology: Repeated-measures prospective cross-sectional study. A sample of patients diagnosed with bronchiectasis will be recruited and matched by age and sex with healthy controls. Pressure pain thresholds (PPTs), conditioned pain modulation (CPM) and referral pain will be assessed before and after the Incremental Shuttle Walking test (ISW). Levels of physical activity will be assessed using accelerometry during a 7-days period. Sleep quality (Pittsburgh sleep quality test), level of catastrophizing (Pain Catastrophizing Scale), level of sensitization (Central Sensitization Inventory) and level of anxiety and depression (Hospital Anxiety and Depression) will be assessed. The assessments will be done twice: 1) at baseline; and 2) at 6 months follow-up period.
Study Type
Observational [Patient Registry]
Primary Outcome
Referred pain area
Secondary Outcome
Number of body areas affected by referred pain
Condition
Bronchiectasis
Intervention
No intervention
Study Arms / Comparison Groups
Adult subjets
Description: Adult subjets diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase, matched by by sex and age with healthy subjects.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
0
Start Date
September 29, 2017
Completion Date
November 30, 2019
Primary Completion Date
October 31, 2019
Eligibility Criteria
Bronchiectasis Group Inclusion Criteria: - Diagnosis of bronchiectasis by high-resolution computed tomography. - Ability to understand and perform all the clinical procedure. - Acquisition of informed consent. Exclusion Criteria: - Diagnosis or clinical suspicion of cystic fibrosis by genetic test or sweat electrolytes test. - Diagnosis of rheumatic disease. - Being on a waiting list for lung transplantation. - Thoraco-abdominal surgery in the last 6 months. - Chronic use of pain medication. Control Group Inclusion Criteria: - Healthy subjects matched by age and sex with Bronchiectasis Group's subjects Exclusion Criteria: - Be taking pain medication. - Presence of pain condition or pathology.
Gender
All
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT03376204
Organization ID
PI17/0290
Responsible Party
Principal Investigator
Study Sponsor
Universidad San Jorge
Study Sponsor
, ,
Verification Date
January 2019