Pain Sensitivity Evaluation in Respiratory Patients
3. marts 2020 opdateret af: 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.
Studieoversigt
Status
Ukendt
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Forventet)
30
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
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 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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).
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Kontrolgruppe
|
|
Astmatiske patienter
|
|
Allergic patients
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pressure pain threslhold
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Borg scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
|
Kinesiophobia was assessed by the Tampa Scale for Kinesiophobia which evaluate the fear of movement due to dyspnea.
|
Baseline
|
|
Kinesiophobia
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
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Sponsor
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 (Forventet)
24. februar 2020
Primær færdiggørelse (Forventet)
12. maj 2020
Studieafslutning (Forventet)
1. juni 2020
Datoer for studieregistrering
Først indsendt
21. februar 2020
Først indsendt, der opfyldte QC-kriterier
3. marts 2020
Først opslået (Faktiske)
5. marts 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. marts 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. marts 2020
Sidst verificeret
1. marts 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DF0090UG
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