Central Sensitisation in Patients With Haemophilia and Degenerative Arthropathy

NCT07110675 | Completed

• 1 other identifier: He-Sens
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Hemophilic arthropathy is characterized by functional impairments, disabling physical sequelae, and chronic pain. Central pain sensitization describes increased neural excitability characterized by spontaneous or persistent pain, increased pain areas, allodynia, and hyperalgesia. Objectives: To evaluate central pain sensitization in patients with hemophilia and degenerative knee and ankle arthropathy and to identify the best predictive model of central pain sensitization in these patients. Methods: Multicenter cross-sectional cohort study. Eighty-six patients with hemophilic knee and ankle arthropathy will be recruited through the Spanish Hemophilia Federation. The primary outcome measure will be central pain sensitization (Central Sensitization Inventory), with age as the dependent variable. The secondary variables will be kinesiophobia (Tampa Scale for Kinesiophobia), catastrophizing (Pain Catastrophizing Scale), and pain anxiety (Pain Anxiety Symptoms Scale-20). The variables estimated as modifiers or confounders will be pain intensity (Visual Analogue Scale), joint status (Hemophilia Joint Health Score), severity and type of hemophilia, development of inhibitors, and sociodemographic variables. Expected results: To identify the degree of central pain sensitization in patients with hemophilic arthropathy. To identify the best predictive model for central pain sensitization in these patients based on the study variables.

Conditions

Hemophilia

Keywords

Hemophilia; Joint pain; Central sensitization; Disability; Kinesiophobia; Catastrophizing; Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• Assessment of central pain sensitivity at baseline.

  The Spanish version of the Central Sensitisation Inventory will be used to assess the presence of central sensitisation in patients. The first part of this inventory consists of 25 items that assess possible healthy symptoms. Each item is assessed using a 5-point Likert scale with a numerical hierarchy: Never (0), Rarely (1), Sometimes (2), Often (3) and Always (4). The second part assesses whether the patient has been diagnosed with any of a list of 10 disorders, including the year of diagnosis. The reliability of this inventory is very high (ICC: 0.82-0.97). The assessment of the first part of this tool ranges from 0 to 100 points, where the higher the score, the greater the clinical severity of the patients.

  Baseline

Secondary Outcomes (4)

• Assessment of fear of movement at baseline

  Baseline

• Assessment of catastrophising at baseline

  Baseline

• Assessment of pain anxiety levels at baseline

  Baseline

• Assessment of pressure pain threshold

  Screening visit

Other Outcomes (7)

• Assessment of joint pain intensity at baseline

  Baseline

• Assessment of joint damage at baseline

  Baseline

• Assessment of the sociodemographic variable age at baseline

  Baseline

Study Arms (1)

Observational group

Patients who meet all inclusion criteria will be informed verbally and in writing of the characteristics, objectives, and risks of the intervention. They will be provided with patient information and informed consent documents. After confirming that they do not meet any of the exclusion criteria, the dependent and confounding variables of the study will be evaluated. The evaluation will be carried out at the premises of the member associations of the Spanish Hemophilia Federation. All evaluations will be performed by the same physical therapist, following the same evaluation protocol.

Eligibility Criteria

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

Study Population

Patients with hemophilia and degenerative knee and ankle arthropathy

You may qualify if:

• Patients diagnosed with haemophilia A and B.
• Over 35 years of age.
• With a medical diagnosis of bilateral haemophilic ankle arthropathy.
• With a clinical assessment using the Hemophilia Joint Health Score greater than 4 points.
• On prophylactic treatment with FVIII/FIX coagulation concentrates or monoclonal antibodies.
• Sign the informed consent document.

You may not qualify if:

• Patients with neurological or cognitive impairments that prevent them from understanding the questionnaires and physical tests.
• Patients who have had ankle or knee haemarthrosis in the 6 months prior to the start of the study.
• Patients who have taken analgesic or anti-inflammatory drugs in the 10 days prior to the study.
• Patients who are undergoing an intervention (physiotherapy or orthopaedic) at the time of the study.

Sponsors & Collaborators

• Investigación en Hemofilia y Fisioterapia: lead

Study Sites (1)

Universidad de Oviedo

Oviedo, Principality of Asturias, 33006, Spain

Location

MeSH Terms

Conditions

Hemophilia A; Arthralgia; Kinesiophobia; Anxiety Disorders; Depression

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; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phobic Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Rubén Cuesta-Barriuso, PhD

  Universidad de Oviedo

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 7, 2025
• Study Start: August 1, 2025
• Primary Completion: October 28, 2025
• Study Completion: December 15, 2025
• Last Updated: February 20, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)