- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT04297098
Pain Sensitivity Evaluation in Respiratory Patients
tiistai 3. maaliskuuta 2020 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Tuntematon
Ehdot
Opintotyyppi
Havainnollistava
Ilmoittautuminen (Odotettu)
30
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 65 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Joo
Sukupuolet, jotka voivat opiskella
Kaikki
Näytteenottomenetelmä
Todennäköisyysnäyte
Tutkimusväestö
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).
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
---|
Kontrolliryhmä
|
Astmapotilaat
|
Allergic patients
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Pressure pain threslhold
Aikaikkuna: 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
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Borg scale
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Baseline
|
Kinesiophobia was assessed by the Tampa Scale for Kinesiophobia which evaluate the fear of movement due to dyspnea.
|
Baseline
|
Kinesiophobia
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
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Maanantai 24. helmikuuta 2020
Ensisijainen valmistuminen (Odotettu)
Tiistai 12. toukokuuta 2020
Opintojen valmistuminen (Odotettu)
Maanantai 1. kesäkuuta 2020
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Perjantai 21. helmikuuta 2020
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Tiistai 3. maaliskuuta 2020
Ensimmäinen Lähetetty (Todellinen)
Torstai 5. maaliskuuta 2020
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Torstai 5. maaliskuuta 2020
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Tiistai 3. maaliskuuta 2020
Viimeksi vahvistettu
Sunnuntai 1. maaliskuuta 2020
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