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Psychology and Physiotherapy Approach of Chronic Pain in Patients With Hemophilia

6 giugno 2019 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

19

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Spagna
      • Valencia, Spagna, 46026
        • Instituto de Investigación Sanitaria La Fe. Hospital Universitari i Politècnic La Fe

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 60 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Descrizione

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

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

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Altro: Psychology and Physiotherapy group

Psychological program: 4 sessions,2 hours each,4 months

  • Psychoeducation.Influence of psychological factors on chronic pain: modulators of pain experience. Biopsychosocial model of pain.
  • Training techniques of psychological management of pain:Diaphragmatic Breathing and Progressive Muscle Relaxation to control vicious circle pain-tension-pain.
  • Kinesiophobia. Rational regulation of the activity level:Cognitive therapy (management of irrational believes about pain) and Organisation of time and reinforcement activities.

Physiotherapy program:3 sessions per week,1 hour per session,4 months:

  • Aerobic exercise:walking, cycling
  • Warm-up: active ROM exercises of inferior and superior extremities (ISE)
  • Progressive resistance training with elastic bands of ISE
  • Stretching of ISE
Comparatore placebo: Placebo Comparator: Control group
Usual daily activities
Altro: Placebo comparator: control group
Control group Normal daily activities Usual daily activities

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in Perceived Self-efficacy: Chronic Pain Self-Efficacy Scale Spainsh Version. (Martín-Aragon et al., 1999).
Lasso di tempo: baseline, 4 months, 7 months
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).
baseline, 4 months, 7 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Quality of Life related with health
Lasso di tempo: baseline, 4 months, 7 months
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).
baseline, 4 months, 7 months
Emotional status
Lasso di tempo: baseline, 4 months, 7 months
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.
baseline, 4 months, 7 months
Nociceptive pain
Lasso di tempo: baseline, 4 months, 7 months
Nociceptive pain will be measured by the Visual Analog Scale for pain (VAS) from 0 to 10, where higher values represent a worse outcome.
baseline, 4 months, 7 months
Neuropathic pain
Lasso di tempo: baseline, 4 months, 7 months
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.
baseline, 4 months, 7 months
Kinesiophobia
Lasso di tempo: baseline, 4 months, 7 months
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).
baseline, 4 months, 7 months
Functional capacity: The Timed "Up & Go" test
Lasso di tempo: baseline, 4 months, 7 months
Timed "Up & Go" will be used to measure functional capacity. Less time to complete the test in seconds implies better outcome
baseline, 4 months, 7 months
Functional capacity: Sit-to-stand test
Lasso di tempo: baseline, 4 months, 7 months
Sit-to-stand test will be used to measure functional capacity. Less time to complete the test in seconds implies better outcome
baseline, 4 months, 7 months
Functional capacity: 2-minutes walk test
Lasso di tempo: baseline, 4 months, 7 months
Evaluation of functional capacity during walking by using 2 minutes walk test. More distance covered in 2 minutes implies better outcome.
baseline, 4 months, 7 months
Self-perceived functional capacity
Lasso di tempo: baseline, 4 months, 7 months
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.
baseline, 4 months, 7 months
Active Range of Movement
Lasso di tempo: baseline, 4 months, 7 months
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.
baseline, 4 months, 7 months
Joint health status
Lasso di tempo: baseline, 4 months, 7 months
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.
baseline, 4 months, 7 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Instituto de Investigacion Sanitaria La Fe

Collaboratori

Pfizer

Investigatori

  • Investigatore principale: María García Dasí, Psych, Instituto de Investigación Sanitaria La Fe. Hospital Universitari i Politècnic La Fe

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 (Effettivo)

14 marzo 2018

Completamento primario (Effettivo)

15 marzo 2019

Completamento dello studio (Effettivo)

15 marzo 2019

Date di iscrizione allo studio

Primo inviato

14 marzo 2018

Primo inviato che soddisfa i criteri di controllo qualità

7 maggio 2018

Primo Inserito (Effettivo)

18 maggio 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 giugno 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 giugno 2019

Ultimo verificato

1 giugno 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2017/0320

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

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 .

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