Pain Mechanisms in Patients With Bronchiectasis
29 januari 2019 uppdaterad av: 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.
Studieöversikt
Status
Indragen
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Zaragoza
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Villanueva de Gállego, Zaragoza, Spanien, 50830
- Universidad San Jorge
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 90 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Adult patients diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Övrig
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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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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Inget ingripande
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Referred pain area
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of body areas affected by referred pain
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: Baseline and after 6 months follow-up
|
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)
Tidsram: 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
Tidsram: 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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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
29 september 2017
Primärt slutförande (Förväntat)
31 oktober 2019
Avslutad studie (Förväntat)
30 november 2019
Studieregistreringsdatum
Först inskickad
19 oktober 2017
Först inskickad som uppfyllde QC-kriterierna
15 december 2017
Första postat (Faktisk)
18 december 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
31 januari 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 januari 2019
Senast verifierad
1 januari 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PI17/0290
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