Conditioned Pain Modulation in Patients With Hemophilia

Last updated: May 23, 2024
Sponsor: Investigación en Hemofilia y Fisioterapia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemophilia

Treatment

Observational group

Clinical Study ID

NCT06267209
He-Modulation
  • Ages 20-65
  • Male

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients diagnosed with hemophilia A or B.

  • Patients over 18 years of age.

  • Persons with a medical diagnosis of bilateral hemophilic ankle arthropathy.

  • Patients with clinical assessment by Hemophilia Joint Health Score (>4 points).

  • Persons with hemophilia on prophylactic treatment with FVIII / FIX coagulationconcentrates or monoclonal antibodies.

  • Have signed the informed consent document.

Exclusion

Exclusion Criteria:

  • Patients with neurological or cognitive alterations that prevent the comprehensionof the questionnaires and physical tests.

  • Patients who have had an ankle hemarthrosis in the 6 months prior to the start ofthe study.

  • Patients who have taken analgesic or anti-inflammatory drugs in the 30 days prior tothe study.

  • Patients who are undergoing an intervention (physiotherapeutic or orthopedic) at thetime of the study.

Study Design

Total Participants: 51
Treatment Group(s): 1
Primary Treatment: Observational group
Phase:
Study Start date:
May 01, 2024
Estimated Completion Date:
June 20, 2024

Connect with a study center

  • University of Oviedo

    Oviedo, Asturias 33006
    Spain

    Active - Recruiting

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