Central Sensitisation in Patients With Haemophilia and Degenerative Arthropathy

Investigación en Hemofilia y Fisioterapia

Status: Enrolling

Conditions: Hemophilia

Study type: Observational

Funder types: NETWORK

Identifiers

NCT07110675

He-Sens

Details and patient eligibility

About

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.

Enrollment: 86 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

86 participants in 1 patient group

Observational group

Description:

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.