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Multicomponent Pain Self-Management in Adults With Haemophilic Arthropathy

2026年10月1日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

70

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Madrid、西班牙
        • Spanish Federation of Haemophilia
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.

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.

无干预: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in pain interference from baseline to 6 months
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Change in pain interference immediately after the intervention
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

其他结果措施

结果测量
措施说明
大体时间
Bleeding episodes and adverse events
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Ruben C Cuesta-Barriuso, PhD、Universidad de Oviedo

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年3月1日

初级完成 (估计的)

2027年12月15日

研究完成 (估计的)

2027年12月30日

研究注册日期

首次提交

2026年10月1日

首先提交符合 QC 标准的

2026年10月1日

首次发布 (实际的)

2026年10月6日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年10月1日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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