Psychology and Physiotherapy Approach of Chronic Pain in Patients With Hemophilia
6 de junio de 2019 actualizado por: Instituto de Investigacion Sanitaria La Fe
Nonpharmacological Approach of Chronic Pain in Patients With Hemophilia: a Combined Approach From Psychology and Physiotherapy
This study evaluates the clinical impact of a combined protocol with cognitive-behavioral intervention and physiotherapy adjuvant to the standard medical treatment in patients with haemophilia that suffer from chronic pain
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The purpose of this study is to improve the perception of the experience of chronic pain, as well as functionality and quality of life in hemophilic patients with chronic pain
Secondary objectives are:
- to change the perception that the patient has of their pain, to improve the coping strategies and to increase the perception of self-efficacy of patients in pain management.
- to increase the resources that allow a better self-regulatory of emotional, cognitive and competential of the pain experience, reverting in the emotional state of patients, particularly in levels of anxiety and depression.
- to improve functional capacity and musculoskeletal status.
- to improve quality of life.
- to determine whether changes / improvements are maintained over time 3 months after finishing the program
Tipo de estudio
Intervencionista
Inscripción (Actual)
19
Fase
- No aplica
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
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Valencia, España, 46026
- Instituto de Investigación Sanitaria La Fe. Hospital Universitari i Politècnic La Fe
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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 60 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Masculino
Descripción
Inclusion Criteria:
- Diagnosis of haemophilia A or B.
- Age between 18 and 60 years.
- Informed consent signed.
- Signs of arthropathy according to clinical criteria (score Gilbert) and / or radiological criteria (score Pettersson) in at least one of the six joints most commonly affected (ankles, knees or elbows)
- Chronic pain (CP) defined as persistent pain lasting at least six months and resistant to conventional medical therapy. It differs from the acute pain not only in its longer duration, but also sometimes persists even after the cause that produced it has disappeared.
- Absence of active coping strategies, understanding the concept of coping as those cognitive and behavioral efforts made by the individual in order to manage internal and external demands generated by their chronic pain condition and that involve a challenge to their potential individual resources.
Exclusion Criteria:
- Presence of inhibitor to FVIII or FIX.
- Another haemostatic defect.
- Patients with severe cognitive deficits with which it is not possible a cognitive psychological intervention.
- The inability to attend physiotherapy sessions for 12 consecutive weeks (7 supervised and 31 self-monitored)
- Surgical procedures performed 6 weeks prior or during the intervention protocol.
- Not acceptance or withdrawal of informed consent
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
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Psychology and Physiotherapy group
The psychological program consists of 4 sessions (2 hours each) comprising psychoeducation, training techniques of psychological management of pain and kinesiophobia resources The physiotherapy program consists of 3 domiciliary sessions per week, including physical exercise and stretching
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Psychological program: 4 sessions,2 hours each,4 months
Physiotherapy program:3 sessions per week,1 hour per session,4 months:
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Comparador de placebos: Placebo Comparator: Control group
Usual daily activities
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Control group Normal daily activities Usual daily activities
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in Perceived Self-efficacy: Chronic Pain Self-Efficacy Scale Spainsh Version. (Martín-Aragon et al., 1999).
Periodo de tiempo: baseline, 4 months, 7 months
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The scale contain 3 Subscales: Self-efficacy in the control of symptoms (score 0-80); Self-efficacy in physical functioning (score 0-60) and Self-efficacy in pain management (score 0-50).
Total Score: 0-190 and higher values represent a better outcome (more Self-Efficacy perceived).
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baseline, 4 months, 7 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Quality of Life related with health
Periodo de tiempo: baseline, 4 months, 7 months
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Measured by a Specific questionnaire for Quality of Life related with health evaluation for adults with haemophilia (A36Haemophilia-QoL), which explores 9 areas.
Subscales and score range: Physical health: 0-32; Daily activities: 0-16; Joints: 0-12; Pain: 0-8; Treatment satisfaction: 0-8; Difficulties treatment: 0-16; Emotional functioning: 0-20; Mental health: 0-12; Social activity: 0-20.
Subscales are summed, with a total score from 0-144 and higher values represent a better outcome (more Quality of Life perceived).
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baseline, 4 months, 7 months
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Emotional status
Periodo de tiempo: baseline, 4 months, 7 months
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Patient's emotional state will be evaluated by Hospital Anxiety and Depression Scale (HAD), which assess the level of anxiety and depression.
Subscales and score range are Anxiety (0-21) and Depression (0-21).
Scoring: items of each subscale are summed, indicating: 0-7 normality, 8-10 probably case, 11-21 anxiety or depression clinical case.
Higher values represent a worse outcome.
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baseline, 4 months, 7 months
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Nociceptive pain
Periodo de tiempo: baseline, 4 months, 7 months
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Nociceptive pain will be measured by the Visual Analog Scale for pain (VAS) from 0 to 10, where higher values represent a worse outcome.
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baseline, 4 months, 7 months
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Neuropathic pain
Periodo de tiempo: baseline, 4 months, 7 months
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Neuropathic pain evaluation by Pain Detect Questionnaire (Pain-Detect-Q-Spanish, with a total score 0-38, indicating: 0-12 absence of neuropathic pain; >12-18 doubtful diagnosis and >18-38 presence of neuropathic pain.
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baseline, 4 months, 7 months
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Kinesiophobia
Periodo de tiempo: baseline, 4 months, 7 months
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Kinesiophobia will be evaluated by Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation.
Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011).
Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).
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baseline, 4 months, 7 months
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Functional capacity: The Timed "Up & Go" test
Periodo de tiempo: baseline, 4 months, 7 months
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Timed "Up & Go" will be used to measure functional capacity.
Less time to complete the test in seconds implies better outcome
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baseline, 4 months, 7 months
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Functional capacity: Sit-to-stand test
Periodo de tiempo: baseline, 4 months, 7 months
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Sit-to-stand test will be used to measure functional capacity.
Less time to complete the test in seconds implies better outcome
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baseline, 4 months, 7 months
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Functional capacity: 2-minutes walk test
Periodo de tiempo: baseline, 4 months, 7 months
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Evaluation of functional capacity during walking by using 2 minutes walk test.
More distance covered in 2 minutes implies better outcome.
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baseline, 4 months, 7 months
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Self-perceived functional capacity
Periodo de tiempo: baseline, 4 months, 7 months
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Impact of haemophilia on self-perceived functional abilities in adults measured by Haemophilia Activities List questionnaire (HAL).
It contains 42 multiple choice questions in seven domains (Sum Score: 42-252).
Normalized scores for the domains and the full questionnaire can also be obtained, being possible scores range from 0 to 100, where 0 represents the worst possible functional status and 100 the best possible functional status.
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baseline, 4 months, 7 months
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Active Range of Movement
Periodo de tiempo: baseline, 4 months, 7 months
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A digital goniometer will be used (Digital absolute Axis goniometer, Baseline evaluation instruments, White Plains, USA) for the measurement of active elbow, knee and ankle range of movement.
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baseline, 4 months, 7 months
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Joint health status
Periodo de tiempo: baseline, 4 months, 7 months
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Joint clinical evaluation of elbows, knees and ankles by using The Hemophilia Joint Health Score 2.1 (HJHS).
The full score range goes from 0 to 124 points (0-20 points for each of the six joints evaluated, plus 4 points for the overall assessment of gait.
0 means no joint damage, whereas the higher the value, the higher the degree of arthropathy.
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baseline, 4 months, 7 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: María García Dasí, Psych, Instituto de Investigación Sanitaria La Fe. Hospital Universitari i Politècnic La Fe
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)
14 de marzo de 2018
Finalización primaria (Actual)
15 de marzo de 2019
Finalización del estudio (Actual)
15 de marzo de 2019
Fechas de registro del estudio
Enviado por primera vez
14 de marzo de 2018
Primero enviado que cumplió con los criterios de control de calidad
7 de mayo de 2018
Publicado por primera vez (Actual)
18 de mayo de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de junio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
6 de junio de 2019
Última verificación
1 de junio de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2017/0320
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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. .