Effectiveness of an Educational Program for Pain Management in Patients With Hemophilic Arthropathy

Официальное название

Effectiveness of an Educational Program for Pain Management in Patients With Hemophilic Arthropathy: A Randomized Controlled Trial

Обзор

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.

Вмешательства

• Другое Educational group
  Patients with hemophilia will receive a structured pain education program delivered through targeted educational sessions.

Первичные конечные точки

• Measurement of Pain Severity and Pain-Related Interference in Daily Life [Срок оценки: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period]

Вторичные конечные точки (6)

• Measurement of Kinesiophobia [Срок оценки: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period]
• Measurement of Pain Catastrophizing [Срок оценки: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period]
• Measurement of Health-Related Quality of Life [Срок оценки: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period]
• Measurement of Anxiety [Срок оценки: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period]
• Measurement of Illness Perception [Срок оценки: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period]
• Measurement of Physical Activity Level [Срок оценки: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period]

Критерии участия

Критерии включения

• Adult patients with a confirmed diagnosis of hemophilia A or B.
• Presence of hemophilic arthropathy.
• Presence of chronic pain.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Universidad de Oviedo — Oviedo

Идентификаторы

NCT: NCT07420387 · HemoPain

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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