CompletedNot Applicable

Central Pain Mechanisms and Clinical and Psychological Factors Associated With Pain Interference in Daily Life in Adults With Hemophilia and Hemophilic Arthropathy

Spain141 participantsStarted 2026-04-22

Plain-language summary

Introduction. Chronic pain is a frequent complication in adults with hemophilia and hemophilic arthropathy that affects functionality and quality of life. In addition to joint damage, central pain mechanisms and psychological factors may contribute to its functional impact, although evidence in this population is limited. Objective. To analyze the association between central pain mechanisms, pain intensity, and pain-related anxiety and pain interference in daily life in adults with hemophilia and hemophilic arthropathy, adjusting for relevant clinical variables. Methods. An analytical observational study with a cross-sectional design will be conducted in 138 adults with hemophilia and hemophilic arthropathy. The dependent variable will be pain interference in daily life (Brief Pain Inventory), the main predictor variables will be central sensitization (Central Sensitization Inventory), conditioned pain modulation (Conditioned Pain Modulation Index), global pain intensity (severity subscale of the Brief Pain Inventory), and pain-related anxiety (Pain Anxiety Symptoms Scale-20). As secondary predictor variables, sleep quality (Pittsburgh Sleep Quality Index) and pain self-efficacy (Pain Self-Efficacy Questionnaire) will be included. As confounding variables, joint damage, age, type of treatment, and history of inhibitor will be considered. The association between variables will be analyzed using multiple linear regression models adjusted for relevant clinical covariates. Expected results. It is expected to identify factors associated with pain interference in adults with hemophilia and hemophilic arthropathy, improving the understanding of its functional impact.

Who can participate

Age range

35 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of hemophilia A or B * Age equal to or greater than 35 years * Clinical diagnosis of hemophilic arthropathy in at least one lower limb joint * Clinically relevant joint involvement, defined as a total score on the Hemophilia Joint Health Score (HJHS) greater than 4 points * Stable prophylactic treatment with FVIII/FIX concentrates or monoclonal antibodies * Provision of written informed consent Exclusion Criteria: * Presence of neurological or cognitive impairments that prevent understanding of the questionnaires or performance of the study tests * Episode of hemarthrosis in the lower limbs within the 3 months prior to assessment * Use of analgesics, nonsteroidal anti-inflammatory drugs, opioids, or other medications with potential effects on pain perception or modulation within the 72 hours prior to assessment * Receiving, at the time of the study, physiotherapy, infiltrative, or orthotic interventions aimed at pain or function of joints affected by hemophilic arthropathy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of pain interference in daily life and global pain intensity at baseline.

Timeframe: Baseline

Trial details

NCT IDNCT07516730

SponsorInvestigación en Hemofilia y Fisioterapia

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2026-06-30

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