Pain Sensitivity Evaluation in Respiratory Patients
3 marzo 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Sconosciuto
Condizioni
Tipo di studio
Osservativo
Iscrizione (Anticipato)
30
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
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).
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
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Gruppo di controllo
|
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Pazienti asmatici
|
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Allergic patients
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pressure pain threslhold
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Borg scale
Lasso di tempo: 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
|
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Leicester Cough Questionnaire
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline
|
Kinesiophobia was assessed by the Tampa Scale for Kinesiophobia which evaluate the fear of movement due to dyspnea.
|
Baseline
|
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Kinesiophobia
Lasso di tempo: Up to 24 weeks
|
Kinesiophobia was assessed by the Tampa Scale for Kinesiophobia which evaluate the fear of movement due to dyspnea.
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Up to 24 weeks
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Anticipato)
24 febbraio 2020
Completamento primario (Anticipato)
12 maggio 2020
Completamento dello studio (Anticipato)
1 giugno 2020
Date di iscrizione allo studio
Primo inviato
21 febbraio 2020
Primo inviato che soddisfa i criteri di controllo qualità
3 marzo 2020
Primo Inserito (Effettivo)
5 marzo 2020
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
5 marzo 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 marzo 2020
Ultimo verificato
1 marzo 2020
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- DF0090UG
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .