Pain Mechanisms in Patients With Bronchiectasis

Characteristics of Underlying Pain Mechanisms in Patients With Bronchiectasis: a Cross-sectional Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Bronchiectasis; Respiratory Disease
• Intervention / Treatment: Other: No intervention

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

Contacts and Locations

Study Locations

• Spain
  • Zaragoza
    • Villanueva de Gállego, Zaragoza, Spain, 50830
      • Universidad San Jorge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult subjets; Adult subjets diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase, matched by by sex and age with healthy subjects.	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Referred pain area	Amount of pixels painted in an electronic body chart (Navigate Pain, Aalborg, Denmark) after supra threshold pain stimulus (STPS) in infraspinatus muscle.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of body areas affected by referred pain	Body chart is divided in 15 regions and the frequency of pain in each one is registered after STPS	Baseline
Pain intensity after supra threshold pain stimulus (STPS)	Level of pain in a visual analogue scale from 0 to 10 after STPS	Baseline
Pressure pain thresholds (PPTs)	Level of pressure tolerated by the patient just before feel pain. The pressure is done with an algometer (SB-MEDIC Electronics, Solna, Sweden). PPTS will be assessed bilaterally in infraspinatus, supraspinatus and medial gastrocnemius muscles.	Baseline
PPTs with a Conditioned Pain Modulation (CPM) pressure stimulus	Level of pressure tolerated by patient just before feel pain. The conditionated pressure stimulus is preform by a blood pressure cuff. CPM will be assessed bilaterally in infraspinatus, supraspinatus and medial gastrocnemius muscles.	Baseline
Total physical activity time	Total time spent per day in physical activities at different intensities equal or superior to 100 counts per minute (≥100 cpm), obtained by accelerometry (Actigraph gt3x+).	7 days period
Sedentary behaviour time	Total time spent per day in physical activities at different intensities inferior to 100 cpm (<100 cpm).	7 days period
Light physical activity time	Total time spent per day in physical activities at intensities between 100 and 1951 cpm (100-1951 cpm).	7 days period
Moderate-Vigorous physical activity time	Total time spent per day in physical activities at intensities equal or superior to 1952 cpm (≥1952 cpm).	7 days period
Level of catastrophizing	Punctuation obtained in Pain Catastrophizing Scale (PCS). It comprises 13 items which focus on thoughts and feelings encountered while experiencing pain. Each item is scored from 0 (not at all) to 4 (all the time) with a total PCS score range from 0-52 points, where higher scores indicating higher levels of pain catastrophizing.	Baseline
Level of sensitization	Punctuation obtained in Central Sensitization Inventory (CSI). CSI assesses 25 health-related symptoms common to Central Sensitivity Syndromes. Responses are recorded about the frequency of each symptom, with a Likert scale from 0 (never) to 4 (always), resulting in a total possible score of 100. Higher scores are associated with a higher degree of self-reported symptomology.	Baseline
Level of anxiety and depression	Punctuation obtained in Hospital Anxiety and Depression (HAD). The HAD is a 14-item self-report scale measuring the presence of symptoms of both anxiety (seven items) and depression (seven items) during the past week. Each item is scored from 0 to 3, so the final score for each subscale is between 0 and 21. The majority of the studies use the cutoffs of 7/8 for possible and 10/11 for probable anxiety or depression.	Baseline
Quality of sleep	Punctuation obtained in Pittsburgh Sleep Quality Index (PSQI). The PSQI is a 19-item, self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations. Each sleep component yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. Sleep component scores were summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.	Baseline
Level of resilience	Punctuation obtained in Brief Resilience Scale (BRS). This is a 6-item self-report scale with a 5-point response scale ranging from 1 (strongly disagree) to 5 (strongly agree). A higher score indicates a higher degree of resilience.	Baseline
Distance in ISW test	Meters reached in the ISW test.	Baseline
Changes in referred pain area	Amount of pixels painted in an electronic body chart (Navigate Pain, Aalborg, Denmark) after supra threshold pain stimulus (STPS) in infraspinatus muscle.	Baseline and after 6 months follow-up
Changes in number of body areas affected by referred pain	Body chart is divided in 15 regions and the frequency of pain in each one is registered after STPS	Baseline and after 6 months follow-up
Changes in pain intensity after supra threshold pain stimulus (STPS)	Level of pain in a visual analogue scale from 0 to 10 after STPS.	Baseline and after 6 months follow-up
Changes in pressure pain thresholds (PPTs)	Level of pressure tolerated by the patient just before feel pain. The pressure is done with an algometer (SB-MEDIC Electronics, Solna, Sweden)	Baseline and after 6 months follow-up
Changes in Pressure Pain Thresholds (PPTs) with a Conditioned Pain Modulation (CPM) pressure stimulus	Level of pressure tolerated by patient just before feel pain. The conditionated pressure stimulus is preform by a blood pressure cuff	Baseline and after 6 months follow-up

Collaborators and Investigators

• Sponsor: Universidad San Jorge

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2017
• Primary Completion (Anticipated): October 31, 2019
• Study Completion (Anticipated): November 30, 2019

Study Registration Dates

• First Submitted: October 19, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Bronchiectasis; Pain mechanisms; Pressure pain threshold; Referred pain
• Additional Relevant MeSH Terms: Bronchial Diseases; Bronchiectasis; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: PI17/0290

Drug and device information, study documents

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