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

NCT07420387 | Not Yet Recruiting

• 1 other identifier: HemoPain
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemophilia

Keywords

Hemophilia; Hemophilic arthropathy; Chronic pain; Pain neuroscience education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Other Outcomes (9)

• Measurement of Age

  Baseline

• Measurement of Marital Status

  Baseline

• Measurement of Educational Level

  Baseline

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients with hemophilia allocated to the intervention group will receive a structured pain education program delivered through targeted educational sessions.

Other: Educational group

Control group

NO INTERVENTION

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.

Interventions

Educational group OTHER

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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Investigación en Hemofilia y Fisioterapia: lead

Study Sites (1)

Universidad de Oviedo

Oviedo, Principality of Asturias, 33006, Spain

Location

MeSH Terms

Conditions

Hemophilia A; Chronic Pain

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rubén Cuesta-Barriuso, PhD

CONTACT

0034 985103386; cuestaruben@uniovi.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: March 27, 2026
• Primary Completion (Estimated): June 28, 2027
• Study Completion (Estimated): September 11, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

ES (1)