Pain Sensitivity Evaluation in Respiratory Patients
3. března 2020 aktualizováno: 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.
Přehled studie
Postavení
Neznámý
Podmínky
Typ studie
Pozorovací
Zápis (Očekávaný)
30
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 65 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Ukázka pravděpodobnosti
Studijní populace
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).
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
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Kontrolní skupina
|
|
Astmatickí pacienti
|
|
Allergic patients
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pressure pain threslhold
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Borg scale
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline
|
Kinesiophobia was assessed by the Tampa Scale for Kinesiophobia which evaluate the fear of movement due to dyspnea.
|
Baseline
|
|
Kinesiophobia
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Očekávaný)
24. února 2020
Primární dokončení (Očekávaný)
12. května 2020
Dokončení studie (Očekávaný)
1. června 2020
Termíny zápisu do studia
První předloženo
21. února 2020
První předloženo, které splnilo kritéria kontroly kvality
3. března 2020
První zveřejněno (Aktuální)
5. března 2020
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
5. března 2020
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
3. března 2020
Naposledy ověřeno
1. března 2020
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- DF0090UG
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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