Effectiveness of an Educational Program for Pain Management in Patients With Hemophilic Arthropathy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Measurement of Pain Severity and Pain-Related Interference in Daily Life
研究概览
简要总结
Introduction: Hemophilic arthropathy is a common complication of hemophilia, characterized by chronic pain, functional limitation, and impaired quality of life. Cognitive-emotional factors such as catastrophizing and kinesiophobia significantly influence the pain experience, supporting the rationale for interventions grounded in the biopsychosocial model and pain neuroscience education.
Objective: To evaluate the efficacy of an educational program based on pain neurobiology, emotional regulation, and cognitive-behavioral strategies on the pain experience in adult patients with hemophilic arthropathy.
Methods: A randomized, controlled clinical trial with two parallel groups (intervention and control) and three assessment time points (pre-intervention, post-intervention, and 6-month follow-up) will be conducted. A total of 70 adult patients with hemophilia A or B and a diagnosis of hemophilic arthropathy with chronic pain will be enrolled and randomly assigned in a 1:1 ratio. The intervention group will receive a structured educational program consisting of three 60-minute sessions focused on pain neurobiology, emotional regulation, cognitive restructuring, coping strategies, and physiological downregulation techniques, including supervised physical activity as an analgesic strategy. The control group will continue with usual care without additional educational intervention. The primary outcome will be pain intensity and pain interference, assessed using the Brief Pain Inventory. Statistical analyses will be performed using repeated-measures ANOVA, with the Group × Time interaction considered the primary effect of interest, under the intention-to-treat principle.
Expected Results: It is anticipated that the intervention group will demonstrate a statistically and clinically significant reduction in pain intensity and pain-related functional interference compared with the control group. A sustained clinical improvement at six months is also expected, supporting the utility of structured educational interventions as a safe and complementary strategy in the management of chronic pain in patients with hemophilic arthropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult patients with a confirmed diagnosis of hemophilia A or B.
- •Presence of hemophilic arthropathy.
- •Presence of chronic pain.
排除标准
- •Patients with neurological or cognitive impairments that preclude understanding of the educational sessions.
- •Patients who have undergone surgical intervention within the two months preceding the educational program
研究组 & 干预措施
Experimental group
Patients with hemophilia allocated to the intervention group will receive a structured pain education program delivered through targeted educational sessions.
干预措施: Educational group (Other)
Control group
Participants allocated to the control group will not receive physiotherapy sessions based on pain education and will continue with their usual routine of physical activity and exercise.
结局指标
主要结局
Measurement of Pain Severity and Pain-Related Interference in Daily Life
时间窗: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period
Pain severity and pain-related interference in daily life will be assessed using the Spanish version of the Brief Pain Inventory (BPI). This instrument evaluates both the intensity of pain and its impact on daily functioning, including general activity, ambulation, usual work, mood, sleep, social relationships, and enjoyment of life. It provides separate scores for pain severity and pain interference, with higher scores indicating greater pain intensity or greater perceived functional impact
次要结局
- Measurement of Kinesiophobia(Baseline, in the week following completion of the intervention, and at the 6-month follow-up period)
- Measurement of Pain Catastrophizing(Baseline, in the week following completion of the intervention, and at the 6-month follow-up period)
- Measurement of Health-Related Quality of Life(Baseline, in the week following completion of the intervention, and at the 6-month follow-up period)
- Measurement of Anxiety(Baseline, in the week following completion of the intervention, and at the 6-month follow-up period)
- Measurement of Illness Perception(Baseline, in the week following completion of the intervention, and at the 6-month follow-up period)
- Measurement of Physical Activity Level(Baseline, in the week following completion of the intervention, and at the 6-month follow-up period)
研究者
Rubén Cuesta-Barriuso
Principal Investigator
Investigación en Hemofilia y Fisioterapia