Safety and Efficacy of Manual Therapy in the Treatment of Hemophilic Arthropathy of the Ankle. A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change from baseline frequency of ankle hemarthrosis after treatment and at 3 weeks
研究概览
简要总结
Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscle strength, mobility and proprioception), intra-articular alterations and chronic pain. Manual therapy techniques are used to treat soft tissue adhesions, relieve pain and reduce tissue sensitivity.
Design. randomized pilot trial. Aimed: To evaluate the safety and effectiveness of a protocol by manual therapy techniques in patients with hemophilic ankle arthropathy.
Patients: 24 patients with ankle arthropathy will be recruited for inclusion in the study. Patients will be recruited in seven centers, from different regions of Spain.
Intervention: Each session will last approximately 50-60 minutes, with 1 physiotherapy session per week for a period of 3 weeks. Patients will be evaluated at baseline, after the intervention, and after a follow-up period of 3 weeks. The treatment program includes 10 exercises that must be administered bilaterally.
Measuring instruments and study variables: Visual Analog Scale and pressure algometer (joint pain); Leg motion (ankle range of motion); and Haemophilia Joint Health Score (joint health). At the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment.
Expected results: To demonstrate the safety of this Physiotherapy technique in patients with hemophilia. Likewise, an improvement in ankle pain, joint motion, joint health and pressure pain threshold.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with hemophilia A and B
- •With severe (<1% FVIII/FIX) or moderate (1-5% FVIII/FIX) phenotype of hemophilia
- •Over 18 years
- •With medical diagnosis of ankle arthropathy and with clinical evaluation by Hemophilia Joint Health Score
- •In prophylactic treatment with FVIII / FIX concentrates for coagulation
排除标准
- •Patients with inhibitors (antibodies against FVIII or FIX)
- •Patients with neurological or cognitive disorders that prevent the understanding of questionnaires and physical tests
- •Failure to sign the informed consent document
结局指标
主要结局
Change from baseline frequency of ankle hemarthrosis after treatment and at 3 weeks
时间窗: Screening visit, within the first seven days after treatment and after two months follow-up
Weekly follow-up by telephone calls in the experimental phase. The evaluator will conduct a survey with closed questions and answers on the clinical manifestations of hemarthrosis to rule out joint or muscle bleeding. The frequency of hemarthrosis will be measured with the total number of bleedings in the study period in each evaluation.
次要结局
- Change from baseline ankle joint pain after treatment and at 3 weeks(Screening visit, within the first seven days after treatment and after two months follow-up)
- Change from baseline pressure pain threshold of ankle after treatment and at 3 weeks(Screening visit, within the first seven days after treatment and after two months follow-up)
- Change from baseline ankle joint damage after treatment and at 3 weeks(Screening visit, within the first seven days after treatment and after two months follow-up)
- Change from baseline ankle range of motion after treatment and at 3 weeks(Screening visit, within the first seven days after treatment and after two months follow-up)