Pain Mechanisms in Patients With Bronchiectasis

Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03376204
• Other study ID #: PI17/0290
• Status: Withdrawn
• Start date: September 29, 2017
• Est. completion date: November 30, 2019

Study information

• Verified date: January 2019
• Source: Universidad San Jorge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 30, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiectasis
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Spain	Universidad San Jorge	Villanueva de Gállego	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Universidad San Jorge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Pain intensity after supra threshold pain stimulus (STPS)	Level of pain in a visual analogue scale from 0 to 10 after STPS	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	Sedentary behaviour time	Total time spent per day in physical activities at different intensities inferior to 100 cpm (<100 cpm).	7 days period
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Distance in ISW test	Meters reached in the ISW test.	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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