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.
調査の概要
詳細な説明
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.
研究の種類
観察的
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Zaragoza
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Villanueva de Gállego、Zaragoza、スペイン、50830
- Universidad San Jorge
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～90年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Adult patients diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：他の
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
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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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介入なし
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Referred pain area
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of body areas affected by referred pain
時間枠：Baseline
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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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline
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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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline and after 6 months follow-up
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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)
時間枠：Baseline and after 6 months follow-up
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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)
時間枠：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
時間枠：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
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年9月29日
一次修了 (予想される)
2019年10月31日
研究の完了 (予想される)
2019年11月30日
試験登録日
最初に提出
2017年10月19日
QC基準を満たした最初の提出物
2017年12月15日
最初の投稿 (実際)
2017年12月18日
学習記録の更新
投稿された最後の更新 (実際)
2019年1月31日
QC基準を満たした最後の更新が送信されました
2019年1月29日
最終確認日
2019年1月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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