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Completed

NCT Number: NCT07110675

Central Sensitisation in Patients With Haemophilia and Degenerative Arthropathy

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Assessment of central pain sensitivity at baseline.

    Time frame: 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.

Secondary outcomes

  1. Assessment of fear of movement at baseline

    Time frame: Baseline

    Fear of movement will be assessed using the Spanish version of the Tampa Scale of Kinesiophobia (TSK-11SV). This scale consists of 11 items, each of which can be scored from 1 to 4. This scale shows high reliability (ICC = 0.87). The score range on the scale is 11 to 44 points, with higher scores indicating greater fear of movement.

  2. Assessment of catastrophising at baseline

    Time frame: Baseline

    The catastrophising of the patients in the study will be measured using the validated Spanish version of the Pain Catastrophising Scale. This scale consists of 13 items, each of which can be scored from 0 to 4. This scale has demonstrated high reliability (ICC = 0.84). The scale ranges from 0 to 52 points, with higher scores indicating greater catastrophising.

  3. Assessment of pain anxiety levels at baseline

    Time frame: Baseline

    The Pain Anxiety Symptoms Scale-20 (PASS-20) will be used to assess levels of anxiety related to pain. This scale has 20 items and measures anxiety and fear responses associated with the experience of chronic or recurrent pain. Each item is rated on a 5-point scale, from 0 (never) to 5 (always). It consists of four domains that measure cognitive anxiety responses, escape and avoidance, fearful thoughts, and physiological anxiety responses. This instrument has shown moderate reliability (CCI= 0.71).

  4. Assessment of pressure pain threshold

    Time frame: Screening visit

    Pressure pain threshold (PPT) at the forearm distal to the painful point will be measured using a handheld algometer with a 1 cm² probe applied perpendicularly to the previously identified site, increasing pressure at a constant rate (≈30 kPa/s or 1 kg/cm²/s) until the participant indicates the transition from pressure to pain; three measurements will be obtained and their mean will be calculated. Unit of measurement: N.

Other outcomes

  1. Assessment of joint pain intensity at baseline

    Time frame: Baseline

    The visual analogue scale will be used to measure perceived joint pain intensity. The score for perceived pain ranges from 0 to 10 points, where 0 is the minimum (no pain) and 10 is the maximum (maximum pain).

  2. Assessment of joint damage at baseline

    Time frame: Baseline

    Joint damage will be measured using the Haemophilia Joint Health Score (HJHS) tool. This scale is designed to identify joint degeneration in the elbows, knees and ankles in children, adolescents and adults with haemophilia. It consists of eight items: inflammation and its duration, pain, muscle atrophy and strength, crepitus, and loss of flexion and extension. This tool has good reliability (ICC > 70). Scores range from 0 to 20 points (maximum joint damage) per joint. To assess total joint damage, a gait assessment (range 0-4 points) is added, with a maximum score of 124 points.

  3. Assessment of the sociodemographic variable age at baseline

    Time frame: Baseline

    The sociodemographic variable age will be measured in months completed from the patient's date of birth to the date of the assessment.

  4. Assessment of the sociodemographic variable marital status at baseline

    Time frame: Baseline

    The sociodemographic variable marital status will be measured using 4 response options (qualitative variable): single / married / divorced / widowed.

  5. Assessment of the clinical variable type of haemophilia at baseline

    Time frame: Baseline

    The clinical variable type of haemophilia will be measured using a dichotomous qualitative variable with two response options: haemophilia A / haemophilia B.

  6. Assessment of the clinical variable severity of haemophilia at baseline

    Time frame: Baseline

    The clinical variable severity of haemophilia will be measured using a qualitative variable with three response options: mild/moderate/severe.

  7. Assessment of the clinical variable development of inhibitors at baseline

    Time frame: Baseline

    The clinical variable development of inhibitors to clotting factor concentrates will be measured using a dichotomous qualitative variable with two response options: yes/no.

Sponsors and collaborators

Lead sponsor

Investigación en Hemofilia y Fisioterapia

Network

Registry information

Official study title

Identification of Central Sensitisation in Patients With Haemophilia and Degenerative Arthropathy of the Lower Limbs. A Cross-sectional Cohort Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2025
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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