Pain Mechanisms in Patients With Bronchiectasis
2019年1月29日 更新者：Víctor Doménech、Universidad San Jorge
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.
研究概览
详细说明
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.
研究类型
观察性的
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Zaragoza
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Villanueva de Gállego、Zaragoza、西班牙、50830
- Universidad San Jorge
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 90年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Adult patients diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase.
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：其他
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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.
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无干预
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Referred pain area
大体时间：Baseline
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Amount of pixels painted in an electronic body chart (Navigate Pain, Aalborg, Denmark) after supra threshold pain stimulus (STPS) in infraspinatus muscle.
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Baseline
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of body areas affected by referred pain
大体时间：Baseline
|
Body chart is divided in 15 regions and the frequency of pain in each one is registered after STPS
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Baseline
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Pain intensity after supra threshold pain stimulus (STPS)
大体时间：Baseline
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Level of pain in a visual analogue scale from 0 to 10 after STPS
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Baseline
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Pressure pain thresholds (PPTs)
大体时间：Baseline
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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.
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Baseline
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PPTs with a Conditioned Pain Modulation (CPM) pressure stimulus
大体时间：Baseline
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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.
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Baseline
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Total physical activity time
大体时间：7 days period
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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+).
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7 days period
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Sedentary behaviour time
大体时间：7 days period
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Total time spent per day in physical activities at different intensities inferior to 100 cpm (<100 cpm).
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7 days period
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Light physical activity time
大体时间：7 days period
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Total time spent per day in physical activities at intensities between 100 and 1951 cpm (100-1951 cpm).
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7 days period
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Moderate-Vigorous physical activity time
大体时间：7 days period
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Total time spent per day in physical activities at intensities equal or superior to 1952 cpm (≥1952 cpm).
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7 days period
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Level of catastrophizing
大体时间：Baseline
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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.
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Baseline
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Level of sensitization
大体时间：Baseline
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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.
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Baseline
|
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Level of anxiety and depression
大体时间：Baseline
|
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.
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Baseline
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Quality of sleep
大体时间：Baseline
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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.
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Baseline
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Level of resilience
大体时间：Baseline
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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.
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Baseline
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Distance in ISW test
大体时间：Baseline
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Meters reached in the ISW test.
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Baseline
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Changes in referred pain area
大体时间：Baseline and after 6 months follow-up
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Amount of pixels painted in an electronic body chart (Navigate Pain, Aalborg, Denmark) after supra threshold pain stimulus (STPS) in infraspinatus muscle.
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Baseline and after 6 months follow-up
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Changes in number of body areas affected by referred pain
大体时间：Baseline and after 6 months follow-up
|
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)
大体时间：Baseline and after 6 months follow-up
|
Level of pain in a visual analogue scale from 0 to 10 after STPS.
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Baseline and after 6 months follow-up
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Changes in pressure pain thresholds (PPTs)
大体时间：Baseline and after 6 months follow-up
|
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
大体时间：Baseline and after 6 months follow-up
|
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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年9月29日
初级完成 (预期的)
2019年10月31日
研究完成 (预期的)
2019年11月30日
研究注册日期
首次提交
2017年10月19日
首先提交符合 QC 标准的
2017年12月15日
首次发布 (实际的)
2017年12月18日
研究记录更新
最后更新发布 (实际的)
2019年1月31日
上次提交的符合 QC 标准的更新
2019年1月29日
最后验证
2019年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.