Identification of Central Sensitisation in Patients With Haemophilia and Degenerative Arthropathy of the Lower Limbs. A Cross-sectional Cohort Study

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Universidad de Oviedo
RECRUITING
Oviedo
Contact Information
Primary
Rubén Cuesta-Barriuso, PhD
cuestaruben@uniovi.es
0034 985103386
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2025-12-15
Participants
Target number of participants: 86
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Investigación en Hemofilia y Fisioterapia

This content was sourced from clinicaltrials.gov