Characteristics of Underlying Pain Mechanisms in Patients With Bronchiectasis: a Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Referred pain area
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of bronchiectasis by high-resolution computed tomography.
- •Ability to understand and perform all the clinical procedure.
- •Acquisition of informed consent.
排除标准
- •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.
结局指标
主要结局
Referred pain area
时间窗: Baseline
Amount of pixels painted in an electronic body chart (Navigate Pain, Aalborg, Denmark) after supra threshold pain stimulus (STPS) in infraspinatus muscle.
次要结局
- Pain intensity after supra threshold pain stimulus (STPS)(Baseline)
- Moderate-Vigorous physical activity time(7 days period)
- Level of sensitization(Baseline)
- Changes in pain intensity after supra threshold pain stimulus (STPS)(Baseline and after 6 months follow-up)
- Changes in pressure pain thresholds (PPTs)(Baseline and after 6 months follow-up)
- Number of body areas affected by referred pain(Baseline)
- Pressure pain thresholds (PPTs)(Baseline)
- Distance in ISW test(Baseline)
- Changes in number of body areas affected by referred pain(Baseline and after 6 months follow-up)
- Changes in Pressure Pain Thresholds (PPTs) with a Conditioned Pain Modulation (CPM) pressure stimulus(Baseline and after 6 months follow-up)
- PPTs with a Conditioned Pain Modulation (CPM) pressure stimulus(Baseline)
- Sedentary behaviour time(7 days period)
- Level of resilience(Baseline)
- Total physical activity time(7 days period)
- Light physical activity time(7 days period)
- Level of catastrophizing(Baseline)
- Level of anxiety and depression(Baseline)
- Quality of sleep(Baseline)
- Changes in referred pain area(Baseline and after 6 months follow-up)
研究者
Víctor Doménech
Physiotherapy Lecturer at San Jorge University and Researcher at iPhysio Research Group from San Jorge University.
Universidad San Jorge