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Pain Mechanisms in Patients With Bronchiectasis

29 janvier 2019 mis à jour par: 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.

Aperçu de l'étude

Statut

Retiré

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Espagne
    • Zaragoza
      • Villanueva de Gállego, Zaragoza, Espagne, 50830
        • Universidad San Jorge

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 90 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Adult patients diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: Autre
  • Perspectives temporelles: Éventuel

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Autre: Aucune intervention
Aucune intervention

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Referred pain area
Délai: Baseline
Amount of pixels painted in an electronic body chart (Navigate Pain, Aalborg, Denmark) after supra threshold pain stimulus (STPS) in infraspinatus muscle.
Baseline

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of body areas affected by referred pain
Délai: Baseline
Body chart is divided in 15 regions and the frequency of pain in each one is registered after STPS
Baseline
Pain intensity after supra threshold pain stimulus (STPS)
Délai: Baseline
Level of pain in a visual analogue scale from 0 to 10 after STPS
Baseline
Pressure pain thresholds (PPTs)
Délai: Baseline
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.
Baseline
PPTs with a Conditioned Pain Modulation (CPM) pressure stimulus
Délai: Baseline
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.
Baseline
Total physical activity time
Délai: 7 days period
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+).
7 days period
Sedentary behaviour time
Délai: 7 days period
Total time spent per day in physical activities at different intensities inferior to 100 cpm (<100 cpm).
7 days period
Light physical activity time
Délai: 7 days period
Total time spent per day in physical activities at intensities between 100 and 1951 cpm (100-1951 cpm).
7 days period
Moderate-Vigorous physical activity time
Délai: 7 days period
Total time spent per day in physical activities at intensities equal or superior to 1952 cpm (≥1952 cpm).
7 days period
Level of catastrophizing
Délai: Baseline
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.
Baseline
Level of sensitization
Délai: Baseline
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.
Baseline
Level of anxiety and depression
Délai: 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.
Baseline
Quality of sleep
Délai: Baseline
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.
Baseline
Level of resilience
Délai: Baseline
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.
Baseline
Distance in ISW test
Délai: Baseline
Meters reached in the ISW test.
Baseline
Changes in referred pain area
Délai: Baseline and after 6 months follow-up
Amount of pixels painted in an electronic body chart (Navigate Pain, Aalborg, Denmark) after supra threshold pain stimulus (STPS) in infraspinatus muscle.
Baseline and after 6 months follow-up
Changes in number of body areas affected by referred pain
Délai: 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)
Délai: Baseline and after 6 months follow-up
Level of pain in a visual analogue scale from 0 to 10 after STPS.
Baseline and after 6 months follow-up
Changes in pressure pain thresholds (PPTs)
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Universidad San Jorge

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

29 septembre 2017

Achèvement primaire (Anticipé)

31 octobre 2019

Achèvement de l'étude (Anticipé)

30 novembre 2019

Dates d'inscription aux études

Première soumission

19 octobre 2017

Première soumission répondant aux critères de contrôle qualité

15 décembre 2017

Première publication (Réel)

18 décembre 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

31 janvier 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 janvier 2019

Dernière vérification

1 janvier 2019

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • PI17/0290

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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