- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04297098
Pain Sensitivity Evaluation in Respiratory Patients
3 de marzo de 2020 actualizado por: 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.
Descripción general del estudio
Estado
Desconocido
Condiciones
Tipo de estudio
De observación
Inscripción (Anticipado)
30
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
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).
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
---|
Grupo de control
|
Pacientes asmáticos
|
Allergic patients
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Pressure pain threslhold
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Borg scale
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline
|
Kinesiophobia was assessed by the Tampa Scale for Kinesiophobia which evaluate the fear of movement due to dyspnea.
|
Baseline
|
Kinesiophobia
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
24 de febrero de 2020
Finalización primaria (Anticipado)
12 de mayo de 2020
Finalización del estudio (Anticipado)
1 de junio de 2020
Fechas de registro del estudio
Enviado por primera vez
21 de febrero de 2020
Primero enviado que cumplió con los criterios de control de calidad
3 de marzo de 2020
Publicado por primera vez (Actual)
5 de marzo de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de marzo de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
3 de marzo de 2020
Última verificación
1 de marzo de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- DF0090UG
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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