Changes in Intra-articular Parameters by Doppler Ultrasound in Patients With Hemophilic Ankle Arthropathy After Manual Therapy Intervention: A Randomized Double-blind Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline sonographic changes after 4 hours
研究概览
简要总结
Introduction: Hemophilic ankle arthropathy is manifested by functional degenerative alterations, intra-articular alterations, and chronic pain. Manual therapy techniques are used in the treatment of hemophilic ankle arthropathy for the improvement of pain and mobility.
Design. Double-blind randomized pilot trial. Aimed: To evaluate the ultrasound changes by means of Doppler imaging after manual therapy intervention.
Patients: A total of 20 adult patients with hemophilic ankle arthropathy will be recruited.
Intervention: Each manual therapy session will last approximately 50 minutes, with 1 session per week for a period of 3 weeks. The treatment program includes 10 techniques that will be administered bilaterally.
Measuring instruments: Patients will be evaluated qualitatively with ultrasound (HEAD-US scale) and assessment with Doppler ultrasound. The clinical variables will be joint damage (Hemophilia Joint Health Score) and pain intensity (Visual Analogue Scale).
Expected results: Check the safety of manual therapy in patients with hemophilia regarding subclinical bleeding. Assess changes related to joint inflammatory state with imaging techniques. Observe changes in pain intensity and joint damage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
盲法说明
Randomization will be performed using a computerized randomization procedure by permuted blocks of 4 subjects in each recruitment center. The 6 possible sequence alternatives will be modified in each block. This task will be carried out by a person who is not involved in the study and who will not know the identity of the subjects.
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with hemophilia A or B.
- •Persons over 18 years of age.
- •Patients with a medical diagnosis of ankle arthropathy (with clinical assessment of more than 4 points on the Hemophilia Joint Health Score.
- •Patients on prophylactic or on-demand treatment with FVIII / FIX concentrates.
- •Sign the informed consent document.
排除标准
- •Patients with inhibitors (antibodies against FVIII or FIX) without treatment with monoclonal antibodies.
- •Patients with neurological or cognitive alterations that impede the comprehension of questionnaires and physical tests.
- •Patients who have developed an ankle hemarthrosis in the 3 months prior to the study.
- •Patients who at the time of the study are receiving ankle physiotherapy treatment.
结局指标
主要结局
Change from baseline sonographic changes after 4 hours
时间窗: Screening visit and after four hours follow-up
Ultrasound changes will be measured with the Haemophilia Early Arthropathy Detection with UltraSound score. This scale evaluates two parameters: i) inflammatory activity (scores synovial hypertrophy from 0 to 2 points depending on whether involvement is identified); and ii) involvement of articular surfaces (assesses articular cartilage and bone involvement). In the assessment of articular cartilage, a score from 0 to 4 is established (0: normal; 4: complete destruction of cartilage or cannot be visualized). Bone is scored from 0 to 2 points (0: normal; 2: involvement with osteophytes).
次要结局
- Change from baseline joint damage after 4 hours(Screening visit and after four hours follow-up)
- Change from baseline joint pain after 4 hours(Screening visit and after four hours follow-up)
- Change from baseline degree of joint inflammation after 4 hours(Screening visit and after four hours follow-up)