Safety and Efficacy of Manual Therapy in the Treatment of Haemophilic Arthropathy of the Ankle. A Randomised Multicentre Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change from baseline hemarthrosis after treatment and at four weeks
研究概览
简要总结
Introduction: Haemophilic ankle arthropathy manifests as functional (deficit in muscle strength, mobility and proprioception), intra-articular degenerative alterations and chronic pain. Manual therapy techniques are characterised by treating the soft tissues with the aim of modifying their density, relieving pain, reducing tissue sensitivity and improving the ranges of mobility. The objective is to evaluate the safety and effectiveness of a manual therapy protocol in patients with haemophilic ankle arthropathy.
Methods: Randomised crossover clinical trial. 13 patients with haemophilic ankle arthropathy from different regions of Spain will be recruited and randomised into two study groups (experimental and control). Each session of the experimental group will last 50 minutes, with 1 physiotherapy session per week for a period of 3 weeks. Patients will be evaluated at the beginning of the study, after the intervention and after a follow-up period of 4 weeks. The treatment programme includes 10 techniques that must be administered bilaterally. The study variables are the frequency of ankle haemarthrosis, range of movement, pressure pain threshold, pain intensity, joint status, biomechanical analysis of gait and balance, functionality and kinesiophobia.
Expected results: To evaluate the safety of manual therapy in patients with haemophilia. To observe changes in pain, mobility, joint condition, stability and functionality of the ankle, and kinesiophobia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with haemophilia A and B
- •With severe haemophilia phenotype (<1% FVIII/FIX)
- •Over 18 years of age
- •With a medical diagnosis of ankle arthropathy and with clinical assessment using the Hemophilia Joint Health Score
- •On prophylactic or on-demand treatment with coagulation factor VIII/FIX concentrates
排除标准
- •Patients with neurological or cognitive disorders that prevent them from understanding the questionnaires and physical tests
- •Failure to sign the informed consent document
结局指标
主要结局
Change from baseline hemarthrosis after treatment and at four weeks
时间窗: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
A self-registration will be used to evaluate the frequency of bleeding, and thus the safety of the technique. This self-registration will be given to each patient at the beginning of the study and they must fill in the number of hemarthrosis and their main characteristics: date, origin (traumatic or spontaneous). The self-registration will be delivered to the evaluator in each of the study evaluations (post-treatment and follow-up).
次要结局
- Change from baseline functional capacity after treatment and at four weeks(Screening visit, within the first seven days after treatment and after four weeks follow-up visit)
- Change from baseline kinesiophobia after treatment and at four weeks(Screening visit, within the first seven days after treatment and after four weeks follow-up visit)
- Change from baseline range of motion after treatment and at four weeks(Screening visit, within the first seven days after treatment and after four weeks follow-up visit)
- Change from baseline joint pain after treatment and at four weeks(Screening visit, within the first seven days after treatment and after four weeks follow-up visit)
- Change from baseline joint status after treatment and at four weeks(Screening visit, within the first seven days after treatment and after four weeks follow-up visit)
- Change from baseline pressure pain threshold after treatment and at four weeks(Screening visit, within the first seven days after treatment and after four weeks follow-up visit)
研究者
Rubén Cuesta-Barriuso
Principal Investigator
Investigación en Hemofilia y Fisioterapia