Efficacy of a Physiotherapy Intervention Through Movement Visualization in Pain Management in Patients With Hemophilic Arthropathy. Randomized Multicenter Clinical Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change from baseline hemarthrosis after treatment and at 2 months
研究概览
简要总结
Background. The recurrence of hemarthrosis in patients with hemophilia favors the development of a progressive, degenerative intra-articular lesion (hemophilic arthropathy). Pain is one of the main clinical manifestations of this arthropathy.
Objective. Assess the safety and efficacy of a pain intervention by visualizing movement using an augmented reality mobile application and immersive 360º video, regarding the frequency of bleeding and the improvement in pain perception and quality of life, joint condition , strength and functionality in patients with hemophilic arthropathy.
Study design. Randomized, multicenter, single-blind clinical study. Method. 70 patients with hemophilia A and B will be recruited in this study. The patients will be recruited in 5 regions of Spain. The 8 dependent variables will be: frequency of bleeding (self-registration), pain (measured with the visual analog scale and pressure algometer, Tampa Scale of Kinesiophobia and Pain Catastrophizing Scale), quality of life (SF-12 scale), anxiety (questionnaire of Anxiety Status-Trait-STAI), joint status (Hemophilia Joint Health Score scale), muscle strength (dynamometer) and functionality (6-Minutes Walking test, Quick Disabilities of the arm, shoulder and hand). Three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 6 months.
Expected results. To observe the efficacy of the visualization of movement in the characteristics of pain, and its implication in the functionality, joint state, muscular strength and the perception of quality of life in patients with hemophilic arthropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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 hemophilia A and B
- •Patients with a medical diagnosis of hemophilic arthropathy and pain
- •People over 18 years of age
- •Patients on prophylactic or on-demand treatment regimen with FVIII / FIX concentrates
排除标准
- •Patients with neurological or cognitive disorders that impede understanding of the questionnaires
- •Pain free patients
- •Amputees, epileptics or patients with severe vision problems
- •Patients who are receiving Physiotherapy treatment at the time of the study
- •Patients who have not signed the informed consent document
结局指标
主要结局
Change from baseline hemarthrosis after treatment and at 2 months
时间窗: Screening visit, within the first seven days after treatment and after two months 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) and location (knee, ankle or elbow). 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 pressure pain threshold after treatment and at 2 months(Screening visit, within the first seven days after treatment and after two months follow-up visit)
- Change from baseline perception of quality of life after treatment and at 2 months(Screening visit, within the first seven days after treatment and after two months follow-up visit)
- Change from baseline catastrophizing after treatment and at 2 months(Screening visit, within the first seven days after treatment and after two months follow-up visit)
- Change from baseline joint status after treatment and at 2 months(Screening visit, within the first seven days after treatment and after two months follow-up visit)
- Change from baseline joint pain after treatment and at 2 months(Screening visit, within the first seven days after treatment and after two months follow-up visit)
- Change from baseline electrical activity of the muscles after treatment and at 2 months(Screening visit, within the first seven days after treatment and after two months follow-up visit)
- Change from baseline perception of anxiety after treatment and at 2 months(Screening visit, within the first seven days after treatment and after two months follow-up visit)
- Change from baseline muscle strength after treatment and at 2 months(Screening visit, within the first seven days after treatment and after two months follow-up visit)
- Change from baseline kinesiophobia after treatment and at 2 months(Screening visit, within the first seven days after treatment and after two months follow-up visit)