Conditioned Pain Modulation in Patients With Hemophilic Arthropathy. A Cross-sectional Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Assess the Conditioned Pain Modulation Index
研究概览
简要总结
Introduction: Hemophilic arthropathy is characterized by functional alterations, disabling physical sequelae, and chronic pain. Conditioned pain modulation describes the net effect of endogenous pathways that enhance or diminish the effects of afferent noxious stimuli.
Objectives: To describe conditioned pain modulation in patients with hemophilia and identify the best predictive model of conditioned pain modulation in these patients Methods: Cross-sectional cohort study. 51 patients with hemophilic arthropathy will be recruited in 3 regions of Spain. The main study variable will be the conditional pain modulation (Conditioned Pain Modulation Index, using an ischemic technique of the arm using the pain pressure threshold as a test stimulus), with age being the dependent variable. The secondary variables, estimated as modifying or confounding variables, will be kinesiophobia (Tampa Scale for Kinesiophobia), catastrophizing (Pain Catstrophizing Scale), trait and state anxiety (State-Trait Anxiety Inventory) and the main clinical, anthropometric, and sociodemographic.
Expected results: Identify the degree of modulation conditioned by pain in patients with hemophilic arthropathy. Identify the best predictive model for conditioned pain modulation 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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with hemophilia A or B.
- •Patients over 18 years of age.
- •Persons with a medical diagnosis of bilateral hemophilic ankle arthropathy.
- •Patients with clinical assessment by Hemophilia Joint Health Score (>4 points).
- •Persons with hemophilia on prophylactic treatment with FVIII / FIX coagulation concentrates or monoclonal antibodies.
- •Have signed the informed consent document.
排除标准
- •Patients with neurological or cognitive alterations that prevent the comprehension of the questionnaires and physical tests.
- •Patients who have had an ankle hemarthrosis in the 6 months prior to the start of the study.
- •Patients who have taken analgesic or anti-inflammatory drugs in the 30 days prior to the study.
- •Patients who are undergoing an intervention (physiotherapeutic or orthopedic) at the time of the study.
结局指标
主要结局
Assess the Conditioned Pain Modulation Index
时间窗: Screening visit
First, we will measure the pain threshold to pressure at the base of the dorsal part of the distal phalanx of the thumb, and then we will provoke the conditioned stimulus using the ischemia test on the contralateral upper limb. For the ischemia test, a sphygmomanometer will be used and inflated to 240 mmHg. The arm will be positioned horizontally. Patients will be asked to indicate the intensity of pain on a numerical pain rating scale until a pain rating of 7/10 appears. Patients will perform resistance exercises in wrist extension by lifting a 2 kg weight up to a maximum of 45 repetitions. With the sphygmomanometer still inflated, pain detection threshold measurements will be repeated at the dorsal aspect of the distal phalanx of the thumb. The time shall not be extended beyond six minutes.
次要结局
- Assess the catastrophizing with Pain catastrophizing scale(Screening visit)
- Assess the joint pain with visual analog scale(Screening visit)
- Assess the pressure pain threshold with pressure algometer(Screening visit)
- Assess the catastrophizing with State-Trait Anxiety Inventory(Screening visit)
- Assess the functional capacity with the 6-Minute Walking test(Screening visit)
- Assess the kinesiophobia with Tampa Scale of Kinesiophofia(Screening visit)
- Assess the joint damage with Haemophilia Joint Health Score(Screening visit)