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Multicomponent Pain Self-Management in Adults With Haemophilic Arthropathy

1 de outubro de 2026 atualizado por: Rubén Cuesta-Barriuso, Investigación en Hemofilia y Fisioterapia

Multicomponent Pain Self-Management Programme in Adults With Haemophilic Arthropathy: Protocol for a Randomised Controlled Trial

Background: Haemophilic arthropathy is associated with chronic pain, functional limitation and impaired quality of life. Pain interference may also be influenced by cognitive, emotional and behavioural factors. Evidence for structured multicomponent pain self-management programmes specifically tailored to adults with haemophilic arthropathy remains limited.

Objective: To evaluate the effectiveness of a structured multicomponent pain self-management programme, compared with usual care, in reducing pain interference in adults with haemophilia A or B, haemophilic arthropathy and chronic pain.

Methods: Approximately 70 adults will be individually randomised in a 1:1 ratio to a multicomponent pain self-management programme or usual care. The intervention will comprise three 60-minute face-to-face group sessions delivered over approximately 6-8 weeks. The programme will integrate pain education, emotional-regulation training and cognitive-behavioural self-management strategies. Assessments will be performed at baseline, immediately after the intervention and at 6 months. The primary outcome will be the between-group difference in change in Brief Pain Inventory-Interference score from baseline to 6 months.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

This is a superiority, individually randomised, partially nested controlled trial with two parallel groups and a 1:1 allocation ratio. Participants allocated to the experimental arm will receive a structured multicomponent pain self-management programme delivered in three educational cohorts of approximately 11-12 participants. The control group will continue with usual care during the 6-month study period.

The intervention will comprise three face-to-face sessions of approximately 60 minutes delivered at 3-4-week intervals. It will integrate education on pain neurobiology and modulation, emotional-regulation training and cognitive-behavioural coping strategies. Content will be specifically adapted to haemophilic arthropathy, including education on distinguishing persistent pain from symptoms suggestive of acute haemarthrosis and a standardised safety pathway for suspected bleeding.

Participants in the control group will continue routine haematological follow-up, prescribed haemostatic and analgesic treatment and their usual physical activity, exercise or physiotherapy. Following completion of the 6-month assessment, control participants will be offered the same multicomponent programme.

Outcomes will be assessed at baseline, immediately after the third intervention session and at 6 months. The primary outcome will be pain interference assessed using the Brief Pain Inventory-Short Form. Secondary outcomes will include pain intensity, kinesiophobia, pain catastrophising, anxiety, depressive symptoms, illness perception, health-related quality of life and physical activity.

Tipo de estudo

Intervencional

Inscrição (Estimado)

70

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Espanha
      • Madrid, Espanha
        • Spanish Federation of Haemophilia
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Macho

Descrição

Inclusion Criteria:

  • Age 18 years or older.
  • Diagnosis of haemophilia A or B.
  • Haemophilic arthropathy previously diagnosed and documented by the participant's haemophilia treatment centre.
  • Persistent or recurrent pain for at least 3 months in one or more affected joints.
  • Sufficient capacity to understand the programme content, follow study instructions and complete the assessment instruments.
  • Ability to provide written informed consent.
  • Sufficient understanding of Spanish to complete the study procedures and questionnaires.

Exclusion Criteria:

  • Neurological or cognitive impairment that interferes with understanding of the intervention or completion of assessments.
  • Musculoskeletal surgery within the 2 months preceding inclusion.
  • Acute bleeding episode or acute musculoskeletal event within the 4 weeks preceding baseline assessment that would preclude valid completion of the assessment.
  • Concurrent participation in another structured educational or psychological intervention programme specifically targeting pain.
  • Insufficient understanding of Spanish to complete the study questionnaires.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Experimental group

Participants will receive three face-to-face group sessions of approximately 60 minutes delivered at 3-4-week intervals over approximately 6-8 weeks. The programme integrates pain education, emotional-regulation training and cognitive-behavioural self-management strategies specifically adapted to adults with haemophilic arthropathy.
Outro: Multicomponent pain self-management programme

The intervention comprises three structured face-to-face group sessions. Content includes pain neurobiology and modulation; distinctions between nociception, pain and tissue damage; biopsychosocial and fear-avoidance models; emotional regulation; diaphragmatic breathing; mindfulness; acceptance and resilience; physical activity; identification of maladaptive beliefs and cognitive distortions; cognitive restructuring; self-instruction; guided imagery; physiological de-arousal; and development of an individual self-management plan. Participants will also receive digital educational materials and between-session home assignments. A standardised safety pathway for suspected acute haemarthrosis will be included.
Sem intervenção: No Intervention

Participants will continue their usual care, including routine haematological follow-up, prescribed haemostatic and analgesic treatment and their usual physical activity, exercise or physiotherapy routines. They will not receive the structured pain self-management programme or its educational materials before completion of the 6-month follow-up. After the final 6-month assessment, they will be offered the same multicomponent programme as the experimental group.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in pain interference from baseline to 6 months
Prazo: Baseline and 6 months

Pain interference will be assessed using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-Interference score is calculated as the mean of seven items scored from 0 to 10, with higher scores indicating greater interference of pain with daily life. The primary outcome is the between-group difference in mean change from baseline to the 6-month follow-up.
Baseline and 6 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in pain interference immediately after the intervention
Prazo: Baseline and immediately after Session 3

BPI-Interference score, calculated as the mean of seven items scored from 0 to 10; higher scores indicate greater pain interference.
Baseline and immediately after Session 3
Change in pain intensity
Prazo: Baseline, immediately after Session 3, and 6 months

Pain intensity will be assessed using the BPI-Severity subscale of the Brief Pain Inventory-Short Form, calculated from its four pain-intensity items. Higher scores indicate greater pain intensity.
Baseline, immediately after Session 3, and 6 months
Change in kinesiophobia
Prazo: Baseline, immediately after Session 3, and 6 months

Kinesiophobia will be assessed using the Spanish version of the Tampa Scale for Kinesiophobia-11SV. Higher scores indicate greater fear of movement.
Baseline, immediately after Session 3, and 6 months
Change in pain catastrophising
Prazo: Baseline, immediately after Session 3, and 6 months

Pain catastrophising will be assessed using the Spanish version of the Pain Catastrophizing Scale. Higher scores indicate greater pain catastrophising.
Baseline, immediately after Session 3, and 6 months
Change in health-related quality of life
Prazo: Baseline, immediately after Session 3, and 6 months

Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The eight SF-36 domains and the physical and mental component summary scores will be analysed. Higher scores indicate better health-related quality of life.
Baseline, immediately after Session 3, and 6 months
Change in depressive symptoms
Prazo: Baseline, immediately after Session 3, and 6 months

Depressive symptoms will be assessed using the Beck Depression Inventory-II (BDI-II), a 21-item self-report questionnaire. Higher scores indicate greater depressive symptom severity.
Baseline, immediately after Session 3, and 6 months
Change in anxiety
Prazo: Baseline, immediately after Session 3, and 6 months

Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI), comprising 20-item state-anxiety and 20-item trait-anxiety subscales. Higher scores indicate greater anxiety.
Baseline, immediately after Session 3, and 6 months
Change in illness perception
Prazo: Baseline, immediately after Session 3, and 6 months

Illness perception will be assessed using the Brief Illness Perception Questionnaire (BIPQ), which assesses cognitive and emotional representations of illness and perceived illness threat.
Baseline, immediately after Session 3, and 6 months
Change in physical activity
Prazo: Baseline, immediately after Session 3, and 6 months

Physical activity will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), with a 7-day recall period. Vigorous and moderate physical activity, walking and sedentary behaviour will be recorded according to the instrument scoring protocol.
Baseline, immediately after Session 3, and 6 months

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Bleeding episodes and adverse events
Prazo: From baseline to the 6-month follow-up

Bleeding episodes, clinically relevant increases in pain and adverse events reported by participants will be recorded throughout follow-up.
From baseline to the 6-month follow-up

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigación en Hemofilia y Fisioterapia

Investigadores

  • Cadeira de estudo: Ruben C Cuesta-Barriuso, PhD, Universidad de Oviedo

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de março de 2027

Conclusão Primária (Estimado)

15 de dezembro de 2027

Conclusão do estudo (Estimado)

30 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

1 de outubro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de outubro de 2026

Primeira postagem (Real)

6 de outubro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de outubro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • HemoPain-2027

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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