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.
Adult patients with a confirmed diagnosis of hemophilia A or B.
Presence of hemophilic arthropathy.
Presence of chronic pain.
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
Parallel
Educational group
Other interventionPatients with hemophilia will receive a structured pain education program delivered through targeted educational sessions.
Measurement of Pain Severity and Pain-Related Interference in Daily Life
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
Measurement of Kinesiophobia
This variable will be assessed using the Spanish version of the Tampa Scale for Kinesiophobia (TSK). This scale evaluates kinesiophobia, defined as an excessive and irrational fear of movement and physical activity associated with the expectation of pain or injury. The instrument provides a total score reflecting the degree of fear-avoidance related to movement, with higher scores indicating greater levels of kinesiophobia.
Measurement of Pain Catastrophizing
This variable will be assessed using the Spanish version of the Pain Catastrophizing Scale (PCS). This instrument measures pain catastrophizing, defined as a negative cognitive-affective response to actual or anticipated pain. The questionnaire evaluates dimensions such as rumination, magnification, and helplessness, providing a total score in which higher values reflect a greater degree of catastrophizing thinking.
Measurement of Health-Related Quality of Life
This variable will be assessed using the Spanish version of the Short Form-36 Health Survey (SF-36). This instrument evaluates health-related quality of life and consists of 36 items covering eight domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health, including one health transition item. A specific score is calculated for each domain, with higher values indicating a better perceived health status. Scores range from 0 to 100 for each dimension.
Measurement of Anxiety
This variable will be assessed using the Spanish version of the Hospital Anxiety and Depression Scale (HADS). This questionnaire evaluates anxiety symptomatology in clinical populations, providing a specific score for the anxiety subscale, with higher values indicating a greater presence of anxious symptoms.
Measurement of Age
This sociodemographic variable will be used to characterize the sample and control for potential confounding factors and will be recorded as a quantitative variable (in years).
Measurement of Marital Status
This sociodemographic variable will be used to characterize the sample and control for potential confounding factors and will be recorded as an ordinal variable (single / married-partnered / divorced / widowed).
Measurement of Educational Level
This sociodemographic variable will be used to characterize the sample and control for potential confounding factors and will be recorded as an ordinal variable (primary education / secondary education / vocational training / university education).
Measurement of Employment Status
This sociodemographic variable will be used to characterize the sample and control for potential confounding factors and will be recorded as an ordinal variable (employed - salaried / self-employed / unemployed / retired).
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