Meroño-Gallut Antonio Javier, Cuesta-Barriuso Rubén, Pérez-Llanes Raúl, Donoso-Úbeda Elena, López-Pina José-Antonio
Tú. Bienestar 360º, Physiotherapy and Medical Center, San Javier-Murcia, Spain.
Department of Physiotherapy, European University of Madrid, Madrid, Spain.
JMIR Res Protoc. 2020 Jul 31;9(7):e15612. doi: 10.2196/15612.
Hemophilic ankle arthropathy is manifested by degenerative functional alterations and chronic pain. Myofascial release techniques are used to treat soft tissue adhesions, relieve pain, and reduce tissue sensitivity.
This study aims to evaluate the safety and efficacy of a protocol using self-myofascial release with a foam roller to be applied in patients with hemophilic ankle arthropathy.
Patients with ankle arthropathy (N=70) will be recruited, enrolled, and assigned to one of two groups-experimental or control-in a 1:1 allocation ratio. Patients will be recruited from 5 centers in different regions of Spain. Patient data will be collected at baseline, posttreatment, and follow-up. The primary outcome will be frequency of ankle joint bleeding (self-reported). The secondary outcomes will be ankle range of motion (measured with a digital goniometer); joint pain (measured with a visual analog scale and an algometer); joint status (measured using the Hemophilia Joint Health Score); muscle strength (measured with a dynamometer); functionality of lower limbs (measured using the 6-minute walking test); activity (self-reported); and muscle flexibility (measured using the fingertip-to-floor test). The treatment program includes 11 exercises that must be administered bilaterally. A mobile app will be developed where each patient will be able to observe the exercises to be carried out. Each session will last 15 minutes with 5 physiotherapy sessions per week for a period of 3 months. It is expected that patients with hemophilia who receive the foam roller intervention will show improvement in mobility, pain, and status of the ankle joint; muscle strength; and function in the lower extremities.
The study has been approved by the institutional review board of the University of Murcia. Patient recruitment will begin in September 2020, and the intervention period will last until June 2021. Data collection will take place between September 2020 and October 2021.
This protocol describes a randomized clinical trial to examine the safety and efficacy of a self-myofascial release intervention using a foam roller in patients with hemophilic ankle arthropathy.
ClinicalTrials.gov NCT03914287; http://clinicaltrials.gov/ct2/show/NCT03914287.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/15612.
血友病性踝关节病表现为退行性功能改变和慢性疼痛。肌筋膜放松技术用于治疗软组织粘连、缓解疼痛并降低组织敏感性。
本研究旨在评估一项使用泡沫轴进行自我肌筋膜放松的方案应用于血友病性踝关节病患者的安全性和有效性。
将招募踝关节病患者（N = 70），按1:1分配比例纳入并分为两组——实验组或对照组。患者将从西班牙不同地区的5个中心招募。将在基线、治疗后和随访时收集患者数据。主要结局将是踝关节出血频率（自我报告）。次要结局将包括踝关节活动范围（用数字测角仪测量）；关节疼痛（用视觉模拟量表和痛觉计测量）；关节状态（用血友病关节健康评分测量）；肌肉力量（用测力计测量）；下肢功能（用6分钟步行试验测量）；活动情况（自我报告）；以及肌肉柔韧性（用指尖触地试验测量）。治疗方案包括11项必须双侧进行的练习。将开发一个移动应用程序，每位患者都可以在其中查看要进行的练习。每次训练持续15分钟，每周进行5次物理治疗，为期3个月。预计接受泡沫轴干预的血友病患者在踝关节的活动度、疼痛和状态；肌肉力量；以及下肢功能方面将有所改善。
该研究已获得穆尔西亚大学机构审查委员会的批准。患者招募将于2020年9月开始，干预期将持续至2021年6月。数据收集将在2020年9月至2021年10月期间进行。
本方案描述了一项随机临床试验，以检验在血友病性踝关节病患者中使用泡沫轴进行自我肌筋膜放松干预的安全性和有效性。
ClinicalTrials.gov NCT03914287；http://clinicaltrials.gov/ct2/show/NCT03914287。
国际注册报告识别码（IRRID）：PRR1-10.2196/15612。
