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Pain Mechanisms in Patients With Bronchiectasis

29 gennaio 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Ritirato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 90 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: Altro
  • Prospettive temporali: Prospettiva

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Altro: Nessun intervento
Nessun intervento

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Referred pain area
Lasso di tempo: Baseline
Amount of pixels painted in an electronic body chart (Navigate Pain, Aalborg, Denmark) after supra threshold pain stimulus (STPS) in infraspinatus muscle.
Baseline

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of body areas affected by referred pain
Lasso di tempo: 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)
Lasso di tempo: Baseline
Level of pain in a visual analogue scale from 0 to 10 after STPS
Baseline
Pressure pain thresholds (PPTs)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline
Meters reached in the ISW test.
Baseline
Changes in referred pain area
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universidad San Jorge

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

29 settembre 2017

Completamento primario (Anticipato)

31 ottobre 2019

Completamento dello studio (Anticipato)

30 novembre 2019

Date di iscrizione allo studio

Primo inviato

19 ottobre 2017

Primo inviato che soddisfa i criteri di controllo qualità

15 dicembre 2017

Primo Inserito (Effettivo)

18 dicembre 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

31 gennaio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 gennaio 2019

Ultimo verificato

1 gennaio 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PI17/0290

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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