Effectiveness of an Educational Program for Pain Management in Patients With Hemophilic Arthropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Educational group.
- Who it may be relevant to
- Registry conditions: Hemophilia. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of an Educational Program for Pain Management in Patients With Hemophilic Arthropathy: A Randomized Controlled Trial
Overview
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.
Interventions
- Other Educational group
Patients with hemophilia will receive a structured pain education program delivered through targeted educational sessions.
Primary outcome measures
- Measurement of Pain Severity and Pain-Related Interference in Daily Life [Time frame: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period]
Secondary outcome measures (6)
- Measurement 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 [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 [Time frame: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period]
- Measurement of Anxiety [Time frame: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period]
- Measurement of Illness Perception [Time frame: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period]
- Measurement of Physical Activity Level [Time frame: Baseline, in the week following completion of the intervention, and at the 6-month follow-up period]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Universidad de Oviedo — Oviedo
Identifiers
NCT: NCT07420387 · HemoPain