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Pain Mechanisms in Patients With Bronchiectasis

29. januar 2019 opdateret af: 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.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Kontakter og lokationer

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Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Andet
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Andet: Ingen indgriben
Ingen indgriben

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Referred pain area
Tidsramme: Baseline
Amount of pixels painted in an electronic body chart (Navigate Pain, Aalborg, Denmark) after supra threshold pain stimulus (STPS) in infraspinatus muscle.
Baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of body areas affected by referred pain
Tidsramme: 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)
Tidsramme: Baseline
Level of pain in a visual analogue scale from 0 to 10 after STPS
Baseline
Pressure pain thresholds (PPTs)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
Meters reached in the ISW test.
Baseline
Changes in referred pain area
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

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Sponsor

Universidad San Jorge

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. september 2017

Primær færdiggørelse (Forventet)

31. oktober 2019

Studieafslutning (Forventet)

30. november 2019

Datoer for studieregistrering

Først indsendt

19. oktober 2017

Først indsendt, der opfyldte QC-kriterier

15. december 2017

Først opslået (Faktiske)

18. december 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. januar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. januar 2019

Sidst verificeret

1. januar 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PI17/0290

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