Central Pain Mechanisms and Clinical and Psychological Factors Associated With Pain Interference in Daily Life in Adults With Hemophilia and Hemophilic Arthropathy

NCT07516730 | Not Yet Recruiting

• 1 other identifier: HE-DOLIFE
• Study Type: observational
• Target: 138
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction. Chronic pain is a frequent complication in adults with hemophilia and hemophilic arthropathy that affects functionality and quality of life. In addition to joint damage, central pain mechanisms and psychological factors may contribute to its functional impact, although evidence in this population is limited. Objective. To analyze the association between central pain mechanisms, pain intensity, and pain-related anxiety and pain interference in daily life in adults with hemophilia and hemophilic arthropathy, adjusting for relevant clinical variables. Methods. An analytical observational study with a cross-sectional design will be conducted in 138 adults with hemophilia and hemophilic arthropathy. The dependent variable will be pain interference in daily life (Brief Pain Inventory), the main predictor variables will be central sensitization (Central Sensitization Inventory), conditioned pain modulation (Conditioned Pain Modulation Index), global pain intensity (severity subscale of the Brief Pain Inventory), and pain-related anxiety (Pain Anxiety Symptoms Scale-20). As secondary predictor variables, sleep quality (Pittsburgh Sleep Quality Index) and pain self-efficacy (Pain Self-Efficacy Questionnaire) will be included. As confounding variables, joint damage, age, type of treatment, and history of inhibitor will be considered. The association between variables will be analyzed using multiple linear regression models adjusted for relevant clinical covariates. Expected results. It is expected to identify factors associated with pain interference in adults with hemophilia and hemophilic arthropathy, improving the understanding of its functional impact.

Conditions

Hemophilia

Keywords

Hemophilia; Chronic pain; Pain measurement; Pain perception; Anxiety; Self-efficacy

Outcome Measures

Primary Outcomes (1)

• Assessment of pain interference in daily life and global pain intensity at baseline.

  The Brief Pain Inventory (BPI-Interference) will be used to assess pain interference in daily life and global pain intensity. This instrument measures the extent to which pain interferes with basic and relevant activities such as general activity, walking, normal work, mood, sleep, social relations, and enjoyment of life. It does not assess pain mechanisms, but rather their perceived functional impact. It consists of 7 items scored from 0 to 10 (0: does not interfere; 10: completely interferes), and the total score is obtained by calculating the mean of the items.

  Baseline

Secondary Outcomes (6)

• Assessment of central sensitisation at baseline.

  Baseline

• Assessment of conditioned pain modulation at baseline.

  Baseline

• Assessment of pain-related anxiety at baseline.

  Baseline

• Assessment of sleep quality at baseline.

  Baseline

• Assessment of pain self-efficacy at baseline.

  Baseline

Other Outcomes (3)

• Assessment of the sociodemographic variable age at baseline

  Baseline

• Assessment of the clinical variable development of inhibitors at baseline

  Baseline

• Assessment of the clinical variable type of treatment at baseline

  Baseline

Study Arms (1)

Observational group

adults with hemophilia and hemophilic arthropathy

Eligibility Criteria

• Age: 35 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hemophilia

You may qualify if:

• Diagnosis of hemophilia A or B
• Age equal to or greater than 35 years
• Clinical diagnosis of hemophilic arthropathy in at least one lower limb joint
• Clinically relevant joint involvement, defined as a total score on the Hemophilia Joint Health Score (HJHS) greater than 4 points
• Stable prophylactic treatment with FVIII/FIX concentrates or monoclonal antibodies
• Provision of written informed consent

You may not qualify if:

• Presence of neurological or cognitive impairments that prevent understanding of the questionnaires or performance of the study tests
• Episode of hemarthrosis in the lower limbs within the 3 months prior to assessment
• Use of analgesics, nonsteroidal anti-inflammatory drugs, opioids, or other medications with potential effects on pain perception or modulation within the 72 hours prior to assessment
• Receiving, at the time of the study, physiotherapy, infiltrative, or orthotic interventions aimed at pain or function of joints affected by hemophilic arthropathy

Sponsors & Collaborators

• Investigación en Hemofilia y Fisioterapia: lead

MeSH Terms

Conditions

Hemophilia A; Chronic Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Rubén Cuesta-Barriuso, PhD

CONTACT

0034 985103386; cuestaruben@uniovi.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 11, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04