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RECRUITINGOBSERVATIONAL

Conditioned Pain Modulation in Patients With Hemophilia

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 coagulation concentrates or monoclonal antibodies. - Have signed the willing to sign a consent form document. Who Should NOT Join This Trial: - Patients with neurological or cognitive alterations that prevent the comprehension of the questionnaires and physical tests. - Patients who have had an ankle hemarthrosis in the 6 months prior to the start of the study. - Patients who have taken analgesic or anti-inflammatory drugs in the 30 days prior to the study. - Patients who are undergoing an intervention (physiotherapeutic or orthopedic) at the time of the study. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 coagulation concentrates or monoclonal antibodies. * Have signed the informed consent document. Exclusion Criteria: * Patients with neurological or cognitive alterations that prevent the comprehension of the questionnaires and physical tests. * Patients who have had an ankle hemarthrosis in the 6 months prior to the start of the study. * Patients who have taken analgesic or anti-inflammatory drugs in the 30 days prior to the study. * Patients who are undergoing an intervention (physiotherapeutic or orthopedic) at the time of the study.

Treatments Being Tested

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.

Locations (1)

University of Oviedo
Oviedo, Principality of Asturias, Spain