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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of fear of movement at 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of joint pain intensity at 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). | Baseline |
| Assessment of joint damage at baseline |
Inclusion Criteria:
Exclusion Criteria:
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Patients with hemophilia and degenerative knee and ankle arthropathy
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| Name | Affiliation | Role |
|---|---|---|
| Rubén Cuesta-Barriuso, PhD | Universidad de Oviedo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Oviedo | Oviedo | Principality of Asturias | 33006 | Spain |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D018771 | Arthralgia |
| D000092442 | Kinesiophobia |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Assessment of catastrophising at 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. | Baseline |
| Assessment of pain anxiety levels at 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). | Baseline |
| Assessment of pressure pain threshold | 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. | Screening visit |
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. |
| Baseline |
| Assessment of the sociodemographic variable age at baseline | The sociodemographic variable age will be measured in months completed from the patient's date of birth to the date of the assessment. | Baseline |
| Assessment of the sociodemographic variable marital status at baseline | The sociodemographic variable marital status will be measured using 4 response options (qualitative variable): single / married / divorced / widowed. | Baseline |
| Assessment of the clinical variable type of haemophilia at baseline | The clinical variable type of haemophilia will be measured using a dichotomous qualitative variable with two response options: haemophilia A / haemophilia B. | Baseline |
| Assessment of the clinical variable severity of haemophilia at baseline | The clinical variable severity of haemophilia will be measured using a qualitative variable with three response options: mild/moderate/severe. | Baseline |
| Assessment of the clinical variable development of inhibitors at 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. | Baseline |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010698 | Phobic Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |