Safety and Effectiveness of a Physiotherapy Intervention Through Movement Visualization in the Approach of Pain in Patients With Hemophilic Arthropathy. Multicenter Randomized Clinical Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 主要终点
- Change from baseline joint bleeding frequency after treatment and at 6 months
研究概览
简要总结
Background. The recurrence of hemarthrosis in patients with hemophilia favors the development of an intra-articular, degenerative and progressive lesion (hemophilic arthropathy). Pain is one of the main clinical manifestations of this arthropathy.
Objective. Assess the safety and efficacy of an intervention in pain through visualization of the movement using a mobile application of augmented reality and immersive 360º video, regarding the frequency of bleeding and the improvement of pain perception and quality of life, joint state , strength and functionality in patients with hemophilic arthropathy.
Study design. Randomized, multicenter, simple blind clinical study.
Method. 140 patients with hemophilia A and B will be recruited in this study. 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 analogue scale and pressure algometer, Tampa Scale of Kinesiophobia and Pain Catastrophizing Scale), quality of life (SF-12 scale), anxiety (questionnaire Anxiety State-Trait-STAI), joint state (Hemophilia Joint Health Score scale), muscular 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 6-month follow-up period.
Expected results. Observe the effectiveness of movement visualization in the characteristics of pain, and its implication in 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
- •Medical diagnosis of hemophilic arthropathy
- •Chronic joint pain
- •Over 18 years
- •On prophylactic treatment or on demand with FVIII / FIX concentrates
排除标准
- •Patients with neurological or cognitive disorders that impede the understanding of the questionnaires
- •Painless patients
- •Amputee, epileptic or seriously impaired vision patients
- •Patients 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 joint bleeding frequency after treatment and at 6 months
时间窗: Screening visit, within the first seven days after treatment and after six months follow-up visit
A self-registration of hemorrhages will be used to assess the frequency of bleeding, and with it the safety of the technique. In the self-registration of bleeding, which will be delivered to each patient at the beginning of the study, the patient must fill in the number of hemarthrosis and the main characteristics of these: date, origin (traumatic or spontaneous) and location (knee, ankle or elbow). The self-registration will be delivered to the evaluator in each of the evaluations of the study (post-treatment and follow-up).
次要结局
- Change from baseline muscle strength after treatment and at 6 months(Screening visit, within the first seven days after treatment and after six months follow-up visit)
- Change from baseline anxiety perception after treatment and at 6 months(Screening visit, within the first seven days after treatment and after six months follow-up visit)
- Change from baseline fear of movement after treatment and at 6 months(Screening visit, within the first seven days after treatment and after six months follow-up visit)
- Change from baseline joint pain after treatment and at 6 months(Screening visit, within the first seven days after treatment and after six months follow-up visit)
- Change from baseline perception of quality of life after treatment and at 6 months(Screening visit, within the first seven days after treatment and after six months follow-up visit)
- Change from baseline joint pain perception after treatment and at 6 months(Screening visit, within the first seven days after treatment and after six months follow-up visit)
- Change from baseline electrical muscle activity after treatment and at 6 months(Screening visit, within the first seven days after treatment and after six months follow-up visit)
- Change from baseline joint status after treatment and at 6 months(Screening visit, within the first seven days after treatment and after six months follow-up visit)
- Change from baseline catastrophism after treatment and at 6 months(Screening visit, within the first seven days after treatment and after six months follow-up visit)
- Change from baseline anxiety perceived after treatment and at 6 months(Screening visit, within the first seven days after treatment and after six months follow-up visit)
- Change from baseline endogenous pain inhibitory system after treatment and at 6 months(Screening visit, within the first seven days after treatment and after six months follow-up visit)