BronchiectasisNCT03376204
Pain Mechanisms in Patients With Bronchiectasis
An observational study of Bronchiectasis and Respiratory Disease, run by Universidad San Jorge at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchiectasis, Respiratory Disease
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 29 Sep 2017to 30 Nov 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase.
Who may be able to join
- Diagnosis of bronchiectasis by high-resolution computed tomography.
- Ability to understand and perform all the clinical procedure.
- Acquisition of informed consent.
- Healthy subjects matched by age and sex with Bronchiectasis Group's subjects
Who cannot join
- 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
- Be taking pain medication.
- Presence of pain condition or pathology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bronchiectasis, Respiratory Disease
- Being tested
- No intervention
- Keywords
- Bronchiectasis, Pain mechanisms, Pressure pain threshold, Referred pain
- Medical subject headings
- Bronchiectasis, Respiration Disorders, Pain, Referred
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (19)
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
Measured: Baseline
Pain intensity after supra threshold pain stimulus (STPS)
Level of pain in a visual analogue scale from 0 to 10 after STPS
Measured: 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.
Measured: 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.
Measured: 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+).
Measured: 7 days period
Sedentary behaviour time
Total time spent per day in physical activities at different intensities inferior to 100 cpm (<100 cpm).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Distance in ISW test
Meters reached in the ISW test.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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
Measured: Baseline and after 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start29 Sep 2017
- Primary completion31 Oct 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Why it stopped: It has been impossible to recruit any participants fulfilling both the inclusion criteria. Therefore, the current study protocol is no longer valid.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Víctor Doménech, Universidad San Jorge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376204
- Sponsor's protocol ID
- PI17/0290
- Status last verified
- Jan 2019
- First submitted
- 19 Oct 2017
- Last updated
- 31 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Underlying Pain Mechanisms in Patients With Bronchiectasis: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03376204
- Acronym / sponsor ID
- PI17/0290
- Conditions
- Bronchiectasis, Respiratory Disease
- Keywords
- Bronchiectasis, Pain mechanisms, Pressure pain threshold, Referred pain
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: It has been impossible to recruit any participants fulfilling both the inclusion criteria. Therefore, the current study protocol is no longer valid.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult subjets | – | Other: No interventionAdult subjets diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase, matched by by sex and age with healthy subjects. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase.
Key inclusion criteria (4 listed)
- Diagnosis of bronchiectasis by high-resolution computed tomography.
- Ability to understand and perform all the clinical procedure.
- Acquisition of informed consent.
- Healthy subjects matched by age and sex with Bronchiectasis Group's subjects
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Adult subjets |
Primary outcome
Referred pain area
Time frame: Baseline
Amount of pixels painted in an electronic body chart (Navigate Pain, Aalborg, Denmark) after supra threshold pain stimulus (STPS) in infraspinatus muscle.
19 secondary outcomes
Number of body areas affected by referred pain
Time frame: Baseline
Pain intensity after supra threshold pain stimulus (STPS)
Time frame: Baseline
Pressure pain thresholds (PPTs)
Time frame: Baseline
PPTs with a Conditioned Pain Modulation (CPM) pressure stimulus
Time frame: Baseline
Total physical activity time
Time frame: 7 days period
Sedentary behaviour time
Time frame: 7 days period
Light physical activity time
Time frame: 7 days period
Moderate-Vigorous physical activity time
Time frame: 7 days period
Level of catastrophizing
Time frame: Baseline
Level of sensitization
Time frame: Baseline
Level of anxiety and depression
Time frame: Baseline
Quality of sleep
Time frame: Baseline
Level of resilience
Time frame: Baseline
Distance in ISW test
Time frame: Baseline
Changes in referred pain area
Time frame: Baseline and after 6 months follow-up
Changes in number of body areas affected by referred pain
Time frame: Baseline and after 6 months follow-up
Changes in pain intensity after supra threshold pain stimulus (STPS)
Time frame: Baseline and after 6 months follow-up
Changes in pressure pain thresholds (PPTs)
Time frame: Baseline and after 6 months follow-up
Changes in Pressure Pain Thresholds (PPTs) with a Conditioned Pain Modulation (CPM) pressure stimulus
Time frame: Baseline and after 6 months follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis and Respiratory Disease, run by Universidad San Jorge at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Referred pain area (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.