Identification of Central Sensitisation in Patients With Haemophilia and Degenerative Arthropathy of the Lower Limbs. A Cross-sectional Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Assessment of central pain sensitivity at baseline.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Assessment of central pain sensitivity at baseline.
时间窗: 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.
次要结局
- 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)
研究者
Rubén Cuesta-Barriuso
Principal Investigator
Investigación en Hemofilia y Fisioterapia