Hemophilia
Conditions
Keywords
Hemophilia, Joint pain, Central sensitization, Disability, Kinesiophobia, Catastrophizing, Anxiety, Depression
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.
Interventions
None listed
Sponsors
Investigación en Hemofilia y Fisioterapia
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of central pain sensitivity at baseline. | 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
| Measure | Time frame | Description |
|---|---|---|
| Assessment of fear of movement at baseline | 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. |
| Assessment of catastrophising at baseline | 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. |
| Assessment of pain anxiety levels at baseline | 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). |
| Assessment of pressure pain threshold | 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. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORRubén Cuesta-Barriuso, PhD
Universidad de Oviedo
Outcome results
None listed