Central Pain Mechanisms and Clinical and Psychological Factors Associated With Pain Interference in Daily Life in Adults With Hemophilia and Hemophilic Arthropathy: A Cross-Sectional Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Assessment of pain interference in daily life and global pain intensity at baseline.
研究概览
简要总结
Introduction. Chronic pain is a frequent complication in adults with hemophilia and hemophilic arthropathy that affects functionality and quality of life. In addition to joint damage, central pain mechanisms and psychological factors may contribute to its functional impact, although evidence in this population is limited.
Objective. To analyze the association between central pain mechanisms, pain intensity, and pain-related anxiety and pain interference in daily life in adults with hemophilia and hemophilic arthropathy, adjusting for relevant clinical variables.
Methods. An analytical observational study with a cross-sectional design will be conducted in 138 adults with hemophilia and hemophilic arthropathy. The dependent variable will be pain interference in daily life (Brief Pain Inventory), the main predictor variables will be central sensitization (Central Sensitization Inventory), conditioned pain modulation (Conditioned Pain Modulation Index), global pain intensity (severity subscale of the Brief Pain Inventory), and pain-related anxiety (Pain Anxiety Symptoms Scale-20). As secondary predictor variables, sleep quality (Pittsburgh Sleep Quality Index) and pain self-efficacy (Pain Self-Efficacy Questionnaire) will be included. As confounding variables, joint damage, age, type of treatment, and history of inhibitor will be considered. The association between variables will be analyzed using multiple linear regression models adjusted for relevant clinical covariates.
Expected results. It is expected to identify factors associated with pain interference in adults with hemophilia and hemophilic arthropathy, improving the understanding of its functional impact.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hemophilia A or B
- •Age equal to or greater than 35 years
- •Clinical diagnosis of hemophilic arthropathy in at least one lower limb joint
- •Clinically relevant joint involvement, defined as a total score on the Hemophilia Joint Health Score (HJHS) greater than 4 points
- •Stable prophylactic treatment with FVIII/FIX concentrates or monoclonal antibodies
- •Provision of written informed consent
排除标准
- •Presence of neurological or cognitive impairments that prevent understanding of the questionnaires or performance of the study tests
- •Episode of hemarthrosis in the lower limbs within the 3 months prior to assessment
- •Use of analgesics, nonsteroidal anti-inflammatory drugs, opioids, or other medications with potential effects on pain perception or modulation within the 72 hours prior to assessment
- •Receiving, at the time of the study, physiotherapy, infiltrative, or orthotic interventions aimed at pain or function of joints affected by hemophilic arthropathy
结局指标
主要结局
Assessment of pain interference in daily life and global pain intensity at baseline.
时间窗: Baseline
The Brief Pain Inventory (BPI-Interference) will be used to assess pain interference in daily life and global pain intensity. This instrument measures the extent to which pain interferes with basic and relevant activities such as general activity, walking, normal work, mood, sleep, social relations, and enjoyment of life. It does not assess pain mechanisms, but rather their perceived functional impact. It consists of 7 items scored from 0 to 10 (0: does not interfere; 10: completely interferes), and the total score is obtained by calculating the mean of the items.
次要结局
- Assessment of central sensitisation at baseline.(Baseline)
- Assessment of conditioned pain modulation at baseline.(Baseline)
- Assessment of pain-related anxiety at baseline.(Baseline)
- Assessment of sleep quality at baseline.(Baseline)
- Assessment of pain self-efficacy at baseline.(Baseline)
- Assessment of joint damage at baseline.(Baseline)
研究者
Rubén Cuesta-Barriuso
Principal Investigator
Investigación en Hemofilia y Fisioterapia