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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemophilia
• Intervention / Treatment: Other: Educational group

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rubén Cuesta-Barriuso, PhD; Phone Number: 0034 985103386; Email: cuestaruben@uniovi.es

Study Locations

• Spain
  • Principality of Asturias
    • Oviedo, Principality of Asturias, Spain, 33006
      • Universidad de Oviedo
      • Contact: Ruben Cuesta-Barriuso, PhD; Phone Number: 0034 985 103 386; Email: cuestaruben@uniovi.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Patients with hemophilia allocated to the intervention group will receive a structured pain education program delivered through targeted educational sessions.	Other: Educational group; Patients with hemophilia will receive a structured pain education program delivered through targeted educational sessions.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, in the week following completion of the intervention, and at the 6-month follow-up period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Baseline, in the week following completion of the intervention, and at the 6-month follow-up period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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).	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).	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).	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).	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)	Baseline

Collaborators and Investigators

• Sponsor: Investigación en Hemofilia y Fisioterapia

Study record dates

Study Major Dates

• Study Start (Estimated): March 27, 2026
• Primary Completion (Estimated): June 28, 2027
• Study Completion (Estimated): September 11, 2027

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Chronic pain; Hemophilia; Hemophilic arthropathy; Pain neuroscience education
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Genetic Diseases, Inborn; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hemic and Lymphatic Diseases; Chronic Pain; Hemophilia A
• Other Study ID Numbers: HemoPain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No