Prospective and Multicenter Study to Assess the Safety and Effectiveness of a Physiotherapy Treatment Through Self-myofascial Release With Foam Roller in Patients With Hemophilic Knee Arthropathy: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change from baseline knee joint pain after treatment and at 2 months
研究概览
简要总结
Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscular strength, mobility and proprioception) (intra-articular alterations) and chronic pain. Myofascial release techniques are used to treat soft tissue adhesions, relieve pain, and reduce tissue sensitivity.
Design. A randomized clinical trial. Directed: To evaluate the safety and effectiveness of a myofascial self-release protocol with Foam Roller applied in patients with hemophilic knee arthropathy.
Patients: 58 patients with knee arthropathy will be recruited for inclusion in the study. The patients will be recruited in 5 centers, from different regions of Spain.
Intervention: Each session will last approximately 15 minutes, with five physical therapy sessions per week over a period of 8 weeks. Patients will be evaluated at the beginning of the study, after the intervention and after a follow-up period of 2 months. The treatment program includes 11 exercises to be administered bilaterally. A mobile application will be developed where each patient can observe the exercises to be performed.
Measurement instruments and study variables: digital goniometer (ankle range of motion); visual analog scale and pressure algometer (joint pain); Hemophilia Joint Health Score (Joint Condition); dynamometer evaluation (muscle strength); 6-minute walk test (lower extremity functionality); Mobile device (activity log); Finger floor test (muscle flexibility). At the same time, the study will make it possible to determine the joint bleeding caused by the applied physiotherapy treatment.
Expected results: demonstrate the safety of this physiotherapy technique in patients with hemophilia. Likewise, an improvement in ankle pain, function and joint movement is expected.
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
- 否
入选标准
- •Patients with a medical diagnosis of hemophilia A or B.
- •Patients with a severe phenotype of hemophilia (<1% FVIII/FIX).
- •Patients with a medical diagnosis of hemophilic knee arthropathy and more than 3 points on the Hemophilia Joint Health Score.
- •Being over 18 years old.
- •No scheduled orthopedic surgeries during the study phase
排除标准
- •Patients with hemarthrosis in the month before the beginning of the study.
- •Patients unable to walk.
- •Severe functional alterations of the upper limb that prevented the exercises.
- •Failure to sign the informed consent document
结局指标
主要结局
Change from baseline knee joint pain 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
Visual analogic scale (VAS). This scale will be used to evaluate the perception of joint pain, where knee joint pain ranges from 0 to 10 points (no pain to maximum perceived pain).
次要结局
- Change from baseline knee range of motion 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 of muscle activation of the quadriceps 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 knee 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 muscle flexibility 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 knee 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 knee muscles strength after treatment and at 2 months(Screening visit, within the first seven days after treatment and after two months follow-up visit)