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Pain Sensitivity Evaluation in Respiratory Patients

2020年3月3日 更新者:Marie Carmen Valenza、Universidad de Granada
Previous studies have reported that asthmatic or chronic pulmonary obstructive disease patients have an increased response to pain stimulus. However, this aspect has not been evaluated in allergic patients. Additionally, the difference in pain sensitivity between asymptomatic period crisis have not been evaluated yet.

調査の概要

状態

わからない

研究の種類

観察的

入学 (予想される)

30

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。

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~65年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

確率サンプル

調査対象母集団

Patients who were between 18 and 65 years of age, accepted to sign the informed consent and presented a diagnosis of persistent asthma, in a well-controlled phase, were recruited from the Pneumology Service of the "Complejo Hospitalario Universitario" (Granada).

説明

Inclusion Criteria:

  • Between 18 and 65 years of age.
  • Accepted to sign the informed consent.
  • Diagnosis of asthma or allergy.

Exclusion Criteria:

  • Cognitive impairment.
  • Orthopedic pathologies limiting test performance.
  • Active smokers.
  • Neurologic pathologies limiting voluntary mobility.

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

コホートと介入

グループ/コホート
対照群
喘息患者
Allergic patients

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
Pressure pain threslhold
時間枠:Baseline
The pain pressure thresholds (PPTs) were evaluated by an analogic manual mechanical algometer. This tool consisted of a circular platform with an area of 1 cm2 area, which was perpendicularly applied to generate progressive pressure on the skin at a 1 kg/sec rate. The points selected were chose based on a previous study in asthma patients. Patient was assessed in a seated position and pressure was applied two times at five bilateral points of the body: At two distal points, the distal thumb phalangeal and the gracilis muscle tendon at the inside of the knee. Further at three points at the chest, the costae II, distal of the midst part of the clavicle, the supraspinous muscle and the trapezius muscle's second portion, between the angulus superior at scapulae and the vertebral column.
Baseline
Pressure pain threslhold
時間枠:Up to 24 weeks
The pain pressure thresholds (PPTs) were evaluated by an analogic manual mechanical algometer. This tool consisted of a circular platform with an area of 1 cm2 area, which was perpendicularly applied to generate progressive pressure on the skin at a 1 kg/sec rate. The points selected were chose based on a previous study in asthma patients. Patient was assessed in a seated position and pressure was applied two times at five bilateral points of the body: At two distal points, the distal thumb phalangeal and the gracilis muscle tendon at the inside of the knee. Further at three points at the chest, the costae II, distal of the midst part of the clavicle, the supraspinous muscle and the trapezius muscle's second portion, between the angulus superior at scapulae and the vertebral column.
Up to 24 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Borg scale
時間枠:Baseline
The Borg scale was used to assess the dyspnea, which is a comprehensive instrument designed to measure breathlessness in patients with respiratory pathology. Patients rated their dyspnoea from 0 to 10, where 0 represents "no dyspnoea" and 10 represents "maximum dyspnoea." A difference of 0.9 units was considered as the minimal clinically important difference (MCID), according to previous studies in patients with respiratory disease
Baseline
Leicester Cough Questionnaire
時間枠:Baseline
The Leicester Cough Questionnaire (LCQ) was used to evaluate cough. This questionnaire brief, easy to administer and well-validated. It consists of 19 items with scores ranging from 1 to 7 and it is divided in three subscales: physical, psychological, and social. The minimum and maximum achievable LCQ total scores are 3 and 21, respectively. A lower LCQ score signifies more cough
Baseline
Leicester Cough Questionnaire
時間枠:Up to 24 weeks
The Leicester Cough Questionnaire (LCQ) was used to evaluate cough. This questionnaire brief, easy to administer and well-validated. It consists of 19 items with scores ranging from 1 to 7 and it is divided in three subscales: physical, psychological, and social. The minimum and maximum achievable LCQ total scores are 3 and 21, respectively. A lower LCQ score signifies more cough
Up to 24 weeks
Borg scale
時間枠:Up to 24 weeks
The Borg scale was used to assess the dyspnea, which is a comprehensive instrument designed to measure breathlessness in patients with respiratory pathology. Patients rated their dyspnoea from 0 to 10, where 0 represents "no dyspnoea" and 10 represents "maximum dyspnoea." A difference of 0.9 units was considered as the minimal clinically important difference (MCID), according to previous studies in patients with respiratory disease
Up to 24 weeks
Catastrophizing about Asthma Scale
時間枠:Baseline
In the Catastrophizing about Asthma Scale (CAS) patients rate the extent to which 24 items expressing catastrophic thoughts and feelings about asthma are applicable to themselves (e.g., "There is nothing I can do to reduce the intensity of the asthma attack", "I worry all the time about whether the asthma attack will end", "I feel I can't go on"). The scale has two subscales, one referring to the situation of an asthma exacerbation (the exacerbation scale; 13 items), the other scale referring to daily life, whenever no exacerbation is present (general scale; 11 items). The CAS has high internal consistency (Cronbach's alpha = .93), excellent test-retest reliability (r = .94), and good construct validity.
Baseline
Catastrophizing about Asthma Scale
時間枠:Up to 24 weeks
In the Catastrophizing about Asthma Scale (CAS) patients rate the extent to which 24 items expressing catastrophic thoughts and feelings about asthma are applicable to themselves (e.g., "There is nothing I can do to reduce the intensity of the asthma attack", "I worry all the time about whether the asthma attack will end", "I feel I can't go on"). The scale has two subscales, one referring to the situation of an asthma exacerbation (the exacerbation scale; 13 items), the other scale referring to daily life, whenever no exacerbation is present (general scale; 11 items). The CAS has high internal consistency (Cronbach's alpha = .93), excellent test-retest reliability (r = .94), and good construct validity.
Up to 24 weeks
Latency and summation
時間枠:Baseline
In each testing session two series of contacts of the mechanical probe with the flexor digitorum muscle (one at ISI 3 s and one at ISI 5 s) were presented to each forearm. The forearms were always alternated between each series of contacts. Ratings of both forearms were used to control for differences in hand dominance and sites of pain.
Baseline
Latency and summation
時間枠:Up to 24 weeks
In each testing session two series of contacts of the mechanical probe with the flexor digitorum muscle (one at ISI 3 s and one at ISI 5 s) were presented to each forearm. The forearms were always alternated between each series of contacts. Ratings of both forearms were used to control for differences in hand dominance and sites of pain.
Up to 24 weeks
Fatigue
時間枠:Baseline
Fatigue was measured by the Fatigue Severity Scale. The Fatigue Severity Scale (FSS) was used to assess fatigue and is a 9-item scale, scored from 1 to 7, with the greater the number suggesting more severe fatigue.
Baseline
Fatigue
時間枠:Up to 24 weeks
Fatigue was measured by the Fatigue Severity Scale. The Fatigue Severity Scale (FSS) was used to assess fatigue and is a 9-item scale, scored from 1 to 7, with the greater the number suggesting more severe fatigue.
Up to 24 weeks
Health status
時間枠:Baseline
The EQ-5D was used to evaluate self-perceived health status and is divided into two sections. The first section contains five questions about mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each question, problems within the domain are evaluated on a three-level basis. Responders can choose between Bno problems^, Bsome problems^, or Bextreme problems^. The second part is a VAS score, which records the responder's self-evaluated health, where 0 is the worst imaginable health and 100 is the best imaginable health.
Baseline
Health status
時間枠:Up to 24 weeks
The EQ-5D was used to evaluate self-perceived health status and is divided into two sections. The first section contains five questions about mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each question, problems within the domain are evaluated on a three-level basis. Responders can choose between Bno problems^, Bsome problems^, or Bextreme problems^. The second part is a VAS score, which records the responder's self-evaluated health, where 0 is the worst imaginable health and 100 is the best imaginable health.
Up to 24 weeks
Exercise capacity
時間枠:Baseline
The 6MWT is a useful measure of functional capacity, targeted at people with at least moderately severe impairment. It has been widely used for measuring the response to therapeutic interventions for pulmonary and cardiac disease
Baseline
Exercise capacity
時間枠:Up to 24 weeks
The 6MWT is a useful measure of functional capacity, targeted at people with at least moderately severe impairment. It has been widely used for measuring the response to therapeutic interventions for pulmonary and cardiac disease
Up to 24 weeks
Kinesiophobia
時間枠:Baseline
Kinesiophobia was assessed by the Tampa Scale for Kinesiophobia which evaluate the fear of movement due to dyspnea.
Baseline
Kinesiophobia
時間枠:Up to 24 weeks
Kinesiophobia was assessed by the Tampa Scale for Kinesiophobia which evaluate the fear of movement due to dyspnea.
Up to 24 weeks

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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 (予想される)

2020年2月24日

一次修了 (予想される)

2020年5月12日

研究の完了 (予想される)

2020年6月1日

試験登録日

最初に提出

2020年2月21日

QC基準を満たした最初の提出物

2020年3月3日

最初の投稿 (実際)

2020年3月5日

学習記録の更新

投稿された最後の更新 (実際)

2020年3月5日

QC基準を満たした最後の更新が送信されました

2020年3月3日

最終確認日

2020年3月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • DF0090UG

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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