- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04319523
Abnormal Pain Processing in COPD Patients
20 de marzo de 2020 actualizado por: Marie Carmen Valenza, Universidad de Granada
Dyspnea, cough, and fatigue are the symptoms characteristic of moderate-severe COPD.
Within the progression of disease was also reported a prevalence of 34-77% of pain symptoms in these patients.
A review observed a higher score in pain intensity/interference associated with multiples pain locations of COPD patients.
Pain in chronic diseases may appear to result from abnormalities in pain processing because of the damage and/or inflammation of peripheral structures.
Descripción general del estudio
Estado
Desconocido
Condiciones
Descripción detallada
Dyspnea, cough, and fatigue are the symptoms characteristic of moderate-severe COPD.
Within the progression of disease was also reported a prevalence of 34-77% of pain symptoms in these patients.
A review observed a higher score in pain intensity/interference associated with multiples pain locations of COPD patients.
Several studies reported that comorbidities, GOLD grade, and breathlessness may contribute to a higher pain prevalence in COPD patients because of the systemic inflammatory process and lung hyperinflation.
Pain in chronic diseases may appear to result from abnormalities in pain processing and alteration of sensitization due to the damage and/or inflammation of peripheral structures.
Tipo de estudio
De observación
Inscripción (Anticipado)
65
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.
Ubicaciones de estudio
-
-
Andalucia
-
Granada, Andalucia, España, 18071
- Faculty of Health Sciences. University of Granada.
-
-
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
50 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
Stable COPD patients with a grade III and IV of Global Initiative for Chronic Obstructive Lung Disease (GOLD).
Patients were recruited in the pneumology services of San Cecilio and Virgen de las Nieves University Hospitals (Granada, Spain).
Descripción
Inclusion Criteria:
- Between 50 and older age
- Accepted to sign the informed consent
Exclusion Criteria:
- comorbidities with a course of chronic pain that interfered with evaluation
- the presence of cognitive impairment to understand the questionnaire
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 |
---|
Sujetos sanos
|
Pacientes con EPOC
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Pressure pain thresholds
Periodo de tiempo: Baseline
|
Pressure pain thresholds (PPT) was used to measure pressure pain sensitivity in muscles with an algometer.
With the patient in a seated position, pressure was applied three times at five bilateral points of the body: the distal thumb phalangeal, the gracilis muscle tendon at the inside of the knee, the distal of the middle part of the clavicle, the supraspinous muscle and the trapezius muscle's second portion.
When the participant reported that pressure changed to pain, the pressure was stopped, and the mean value was registered.
|
Baseline
|
Temporal summation
Periodo de tiempo: Baseline
|
Temporal summation (TS) was used to evaluated peripheral sensitization.
First, the pressure was applied with gradually increasing pressure until the subject reported pain in the flexor digitorum muscle of each arm.
Second, 15 stimuli were applicated to one arm at an interstimulus interval (ISI) of 3 s and then to the other arm at an ISI of 5 s.
After a 5 min, the series of stimuli were repeated in reverse order.
The evaluation of TS was measured with a standardized numerical scale for rating the magnitude of late sensations experienced during the first, fifth, tenth, and fifteenth stimuli, and 15 and 60 s after the last stimulus in each series to evaluated the temporal summation.
The scale ranged from 0 (no pain) to 100 (intolerable pain).
|
Baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Pain Sensitivity Questionnaire
Periodo de tiempo: Baseline
|
The Pain Sensitivity Questionnaire (PSQ) measured general pain sensitivity.
It consists of 17 items, each describing a daily life situation and asking the patients to rate how painful this situation would be for them on a numeric rating scale ranging from 0 (not painful) to 10 (worst pain imaginable).
A major score in the questionnaire a higher pain sensitivity.
|
Baseline
|
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
|
International Physical Activity Questionnaire
Periodo de tiempo: Baseline
|
The International Physical Activity Questionnaire (IPAQ) measures total physical activity (MET·minutes·days per week).
|
Baseline
|
Hospital Anxiety and Depression Scale
Periodo de tiempo: Baseline
|
The HADS is a self-rated questionnaire originally developed for minor depressive symptoms in general medical outpatients.
It consists of 14 items, depression (seven items) and anxiety (seven times), each with four choices numbered alphabetically.
Each of the subscales' scores ranges from 0 to 21, corresponding to total scores of 0 to 42, with higher scores indicating greater distress.
|
Baseline
|
London Chest Activity of Daily Living
Periodo de tiempo: Baseline
|
The London Chest Activity of Daily Living (LCADL) was used to assess the impact and severity of breathlessness on ADLs.
The LCADL has been used as an outcome measure in COPD.
Higher scores reflect greater breathlessness during daily activity and the tool includes an anchor question identifying an individual's overall perception of the impact of breathlessness on their daily life.
|
Baseline
|
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 (Actual)
1 de noviembre de 2018
Finalización primaria (Anticipado)
15 de junio de 2020
Finalización del estudio (Anticipado)
3 de diciembre de 2021
Fechas de registro del estudio
Enviado por primera vez
20 de marzo de 2020
Primero enviado que cumplió con los criterios de control de calidad
20 de marzo de 2020
Publicado por primera vez (Actual)
24 de marzo de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de marzo de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
20 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
- DF0087UG
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
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .