NCT06267209

Conditioned Pain Modulation in Patients With Hemophilia

Conditioned Pain Modulation in Patients With Hemophilic Arthropathy. A Cross-sectional Cohort Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 51 (estimated)
• Sponsor: Investigación en Hemofilia y Fisioterapia · Network
• Sex: Male
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Introduction: Hemophilic arthropathy is characterized by functional alterations, disabling physical sequelae, and chronic pain. Conditioned pain modulation describes the net effect of endogenous pathways that enhance or diminish the effects of afferent noxious stimuli. Objectives: To describe conditioned pain modulation in patients with hemophilia and identify the best predictive model of conditioned pain modulation in these patients Methods: Cross-sectional cohort study. 51 patients with hemophilic arthropathy will be recruited in 3 regions of Spain. The main study variable will be the conditional pain modulation (Conditioned Pain Modulation Index, using an ischemic technique of the arm using the pain pressure threshold as a test stimulus), with age being the dependent variable. The secondary variables, estimated as modifying or confounding variables, will be kinesiophobia (Tampa Scale for Kinesiophobia), catastrophizing (Pain Catstrophizing Scale), trait and state anxiety (State-Trait Anxiety Inventory) and the main clinical, anthropometric, and sociodemographic. Expected results: Identify the degree of modulation conditioned by pain in patients with hemophilic arthropathy. Identify the best predictive model for conditioned pain modulation in these patients based on the study variables

Conditions

• Hemophilia

Interventions

Type	Name	Description
OTHER	Observational group	After confirming that the patients not meet any of the exclusion criteria, dependent and confounding study variables will be assessed. Patients will be recruited in 3 regions of Spain (Galicia, Madrid and Malaga), through the respective provincial associations and the Spanish Federation of Hemophilia. The assessment will take place at the premises of the hemophilia associations included in the study. All the evaluations will be carried out by the same physiotherapist, following the same evaluation protocol. The primary variable of the study will be the conditioned modulation of pain, being age the dependent variable. Secondary variables, estimated as modifiers or confounders, will be kinesiophobia, catastrophizing, anxiety perception, joint damage, pain intensity, functional capacity and pain threshold to pressure, and type of treatment and development of inhibitors.

Timeline

• Start date: 2024-05-01
• Primary completion: 2024-06-03
• Completion: 2024-06-20
• First posted: 2024-02-20
• Last updated: 2024-05-24

Locations

1 site across 1 country: Spain