Conditioned Pain Modulation in Patients With Hemophilia

NCT ID: NCT06267209

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 51 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2024-06-20

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Observacional group

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.

Observational group

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Investigación en Hemofilia y Fisioterapia

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Oviedo

Oviedo, Principality of Asturias, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Rubén Cuesta-Barriuso, PhD

Role: CONTACT

cuestaruben@uniovi.es

607547274

Facility Contacts

Rubén Cuesta-Barriuso, PhD

Role: primary

Other Identifiers

He-Modulation

Identifier Type: -

Identifier Source: org_study_id