- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07860632
Multicomponent Pain Self-Management in Adults With Haemophilic Arthropathy
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Rubén Cuesta-Barriuso, PhD
- 전화번호: 0034 985103386
- 이메일: cuestaruben@uniovi.es
연구 장소
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Madrid, 스페인
- Spanish Federation of Haemophilia
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연락하다:
- Rubén Cuesta-Barriuso, PhD
- 전화번호: 0034 985 103 386
- 이메일: cuestaruben@uniovi.es
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
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간섭 없음: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in pain interference from baseline to 6 months
기간: Baseline and 6 months
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in pain interference immediately after the intervention
기간: Baseline and immediately after Session 3
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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
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Change in pain intensity
기간: Baseline, immediately after Session 3, and 6 months
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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
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Change in kinesiophobia
기간: Baseline, immediately after Session 3, and 6 months
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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
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Change in pain catastrophising
기간: Baseline, immediately after Session 3, and 6 months
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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
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Change in health-related quality of life
기간: Baseline, immediately after Session 3, and 6 months
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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
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Change in depressive symptoms
기간: Baseline, immediately after Session 3, and 6 months
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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
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Change in anxiety
기간: Baseline, immediately after Session 3, and 6 months
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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
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Change in illness perception
기간: Baseline, immediately after Session 3, and 6 months
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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
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Change in physical activity
기간: Baseline, immediately after Session 3, and 6 months
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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
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Bleeding episodes and adverse events
기간: From baseline to the 6-month follow-up
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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
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공동 작업자 및 조사자
수사관
- 연구 의자: Ruben C Cuesta-Barriuso, PhD, Universidad de Oviedo
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- HemoPain-2027
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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