Central Sensitisation in Patients With Haemophilia and Degenerative Arthropathy

NCT ID: NCT07110675

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 86 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2025-12-15

Brief Summary

Introduction: Hemophilic arthropathy is characterized by functional impairments, disabling physical sequelae, and chronic pain. Central pain sensitization describes increased neural excitability characterized by spontaneous or persistent pain, increased pain areas, allodynia, and hyperalgesia.

Objectives: To evaluate central pain sensitization in patients with hemophilia and degenerative knee and ankle arthropathy and to identify the best predictive model of central pain sensitization in these patients.

Methods: Multicenter cross-sectional cohort study. Eighty-six patients with hemophilic knee and ankle arthropathy will be recruited through the Spanish Hemophilia Federation. The primary outcome measure will be central pain sensitization (Central Sensitization Inventory), with age as the dependent variable. The secondary variables will be kinesiophobia (Tampa Scale for Kinesiophobia), catastrophizing (Pain Catastrophizing Scale), and pain anxiety (Pain Anxiety Symptoms Scale-20). The variables estimated as modifiers or confounders will be pain intensity (Visual Analogue Scale), joint status (Hemophilia Joint Health Score), severity and type of hemophilia, development of inhibitors, and sociodemographic variables.

Expected results: To identify the degree of central pain sensitization in patients with hemophilic arthropathy. To identify the best predictive model for central pain sensitization in these patients based on the study variables.

Conditions

Hemophilia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Observational group

Patients who meet all inclusion criteria will be informed verbally and in writing of the characteristics, objectives, and risks of the intervention. They will be provided with patient information and informed consent documents. After confirming that they do not meet any of the exclusion criteria, the dependent and confounding variables of the study will be evaluated. The evaluation will be carried out at the premises of the member associations of the Spanish Hemophilia Federation. All evaluations will be performed by the same physical therapist, following the same evaluation protocol.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with haemophilia A and B.
• Over 35 years of age.
• With a medical diagnosis of bilateral haemophilic ankle arthropathy.
• With a clinical assessment using the Hemophilia Joint Health Score greater than 4 points.
• On prophylactic treatment with FVIII/FIX coagulation concentrates or monoclonal antibodies.
• Sign the informed consent document.

Exclusion Criteria

• Patients with neurological or cognitive impairments that prevent them from understanding the questionnaires and physical tests.
• Patients who have had ankle or knee haemarthrosis in the 6 months prior to the start of the study.
• Patients who have taken analgesic or anti-inflammatory drugs in the 10 days prior to the study.
• Patients who are undergoing an intervention (physiotherapy or orthopaedic) at the time of the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Investigación en Hemofilia y Fisioterapia

NETWORK

Sponsor Role: lead

Responsible Party

Rubén Cuesta-Barriuso

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rubén Cuesta-Barriuso, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Oviedo

Locations

Universidad de Oviedo

Oviedo, Principality of Asturias, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Rubén Cuesta-Barriuso, PhD

Role: CONTACT

cuestaruben@uniovi.es

0034 985103386

Facility Contacts

Rubén Cuesta-Barriuso, PhD

Role: primary

cuestaruben@uniovi.es

0034 985 103 386

Other Identifiers

He-Sens

Identifier Type: -

Identifier Source: org_study_id