An interventional study of Educational group in Hemophilia, sponsored by Investigación en Hemofilia y Fisioterapia. Not yet recruiting at 1 site in Spain. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by Investigación en Hemofilia y Fisioterapia · Not applicable, Interventional, and Treatment
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.
866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.
This study's planned enrollment of 70 is above the median of 28 across 512 interventional studies indexed under Hemophilia A.
Browse Hemophilia A studies →Investigación en Hemofilia y Fisioterapia is the lead sponsor of 54 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with hemophilia allocated to the intervention group will receive a structured pain education program delivered through targeted educational sessions.
Other: Educational 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.
Patients 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
Time frame: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period
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.
Time frame: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period
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.
Time frame: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period
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.
Time frame: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period
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.
Time frame: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period
Measurement of Illness Perception
This variable will be assessed using the Spanish version of the Brief Illness Perception Questionnaire (BIPQ). This instrument evaluates illness perception, defined as the set of cognitive and emotional beliefs and representations that a patient holds regarding their disease. The questionnaire assesses dimensions such as perceived consequences, personal control, concern, illness coherence (understanding of the disease), and emotional response, yielding scores that reflect the degree of perceived illness threat.
Time frame: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period
Measurement of Physical Activity Level
This variable will be assessed using the International Physical Activity Questionnaire (IPAQ). This instrument evaluates the level of physical activity, allowing participants to be classified according to their activity level and enabling quantification of physical activity performed across different contexts. This variable will be included to describe the study sample and to explore its potential influence on pain perception and on the outcomes of the intervention.
Time frame: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period
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).
Time frame: Baseline
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).
Time frame: Baseline
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).
Time frame: Baseline
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).
Time frame: Baseline
Measurement of Type of Hemophilia
This clinical variable will be used to characterize the sample and control for potential confounding factors and will be recorded as a dichotomous variable (hemophilia A / hemophilia B).
Time frame: Baseline
Measurement of Hemophilia Severity
This clinical variable will be used to characterize the sample and control for potential confounding factors and will be recorded as an ordinal variable (severe / moderate / mild).
Time frame: Baseline
Measurement of Type of Medical Treatment
This clinical variable will be used to characterize the sample and control for potential confounding factors and will be recorded as a dichotomous variable (on-demand / prophylaxis).
Time frame: Baseline
Measurement of Inhibitor Status
This clinical variable will be used to characterize the sample and control for potential confounding factors and will be recorded as a dichotomous variable (yes / no).
Time frame: Baseline
Measurement of Regular Analgesic Medication Use
This clinical variable will be used to characterize the sample and control for potential confounding factors and will be recorded as a dichotomous variable (yes / no)
Time frame: Baseline
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Investigación en Hemofilia y Fisioterapia