Clinical trial NCT03376204: Pain Mechanisms in Patients With Bronchiectasis
Official title: Characteristics of Underlying Pain Mechanisms in Patients With Bronchiectasis: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Bronchiectasis
Respiratory Disease
Keywords: Bronchiectasis
Pain mechanisms
Pressure pain threshold
Referred pain
Lead sponsor: Universidad San Jorge
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase.

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.

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.

Primary outcomes:
measure: Referred pain area
timeFrame: Baseline
Secondary outcomes:
measure: Number of body areas affected by referred pain
timeFrame: Baseline
measure: Pain intensity after supra threshold pain stimulus (STPS)
timeFrame: Baseline
measure: Pressure pain thresholds (PPTs)
timeFrame: Baseline
measure: PPTs with a Conditioned Pain Modulation (CPM) pressure stimulus
timeFrame: Baseline
measure: Total physical activity time
timeFrame: 7 days period
measure: Sedentary behaviour time
timeFrame: 7 days period
measure: Light physical activity time
timeFrame: 7 days period
measure: Moderate-Vigorous physical activity time
timeFrame: 7 days period
measure: Level of catastrophizing
timeFrame: Baseline
measure: Level of sensitization
timeFrame: Baseline
measure: Level of anxiety and depression
timeFrame: Baseline
measure: Quality of sleep
timeFrame: Baseline
measure: Level of resilience
timeFrame: Baseline
measure: Distance in ISW test
timeFrame: Baseline
measure: Changes in referred pain area
timeFrame: Baseline and after 6 months follow-up
measure: Changes in number of body areas affected by referred pain
timeFrame: Baseline and after 6 months follow-up
measure: Changes in pain intensity after supra threshold pain stimulus (STPS)
timeFrame: Baseline and after 6 months follow-up
measure: Changes in pressure pain thresholds (PPTs)
timeFrame: Baseline and after 6 months follow-up
measure: Changes in Pressure Pain Thresholds (PPTs) with a Conditioned Pain Modulation (CPM) pressure stimulus
timeFrame: Baseline and after 6 months follow-up
Other outcomes:
Locations:
city: Villanueva de Gállego
country: Spain
facility: Universidad San Jorge
state: Zaragoza
Study officials:
References: