Psychology and Physiotherapy Approach of Chronic Pain in Patients With Hemophilia
6 juin 2019 mis à jour par: 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
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Interventionnel
Inscription (Réel)
19
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Valencia, Espagne, 46026
- Instituto de Investigación Sanitaria La Fe. Hospital Universitari i Politècnic La Fe
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 60 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Homme
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Comparateur placebo: Placebo Comparator: Control group
Usual daily activities
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Control group Normal daily activities Usual daily activities
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes in Perceived Self-efficacy: Chronic Pain Self-Efficacy Scale Spainsh Version. (Martín-Aragon et al., 1999).
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Quality of Life related with health
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: María García Dasí, Psych, Instituto de Investigación Sanitaria La Fe. Hospital Universitari i Politècnic La Fe
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
14 mars 2018
Achèvement primaire (Réel)
15 mars 2019
Achèvement de l'étude (Réel)
15 mars 2019
Dates d'inscription aux études
Première soumission
14 mars 2018
Première soumission répondant aux critères de contrôle qualité
7 mai 2018
Première publication (Réel)
18 mai 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 juin 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 juin 2019
Dernière vérification
1 juin 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2017/0320
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
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Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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