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临床试验/NCT04590456
NCT04590456Unknown不适用

Efficacy of Pulsed Electromagnetic Field on Hemarthrotic Knee in Haemophilic Adolescence

Delta University for Science and Technology2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
swelling

研究概览

简要总结

To assess the effect of pulsed electero- magnetic field on swelling, range of motion and muscle strength of hemarthrotic knee joints of haemophilic subjects.

详细描述

Haemophilia is an X-linked hereditary sex recessive disorder that impairs the body's ability to make blood clots. It includes two types: A (FVIII deficit factor) and B (IX deficit factor), depending on FVIII/FIX percentage in blood. The severity of haemophilia is classified into (severe: <1%, moderate: 1-5%, and mild: >5%). The prevalence of haemophilia A is 1: 5000 live births and haemophilia B is 1: 30000 live births.

This disease is characterized by hemarthrosis which is a hemorrhage in the locomotor system, mainly muscles and joints. Joint bleeding mainly occurs in knees, ankles and elbows. Haemorrhage in the muscle or joints accounts for 80% to 90% of all bleeding episodes in people with haemophilia. The most commonly affected joints in non-prophylaxis patients are the knees (45%) which is thought to be due to the large size of the synovial membrane and large rotational forces present. It is followed by the elbows (30%), ankles (15%), shoulders (3%), and wrists (2%). Bleeds are best detected by the patients themselves as bruising and swelling or described as a feeling of warmth or tingling within the joint preceding the clinical signs.

Pulsed electromagnetic field (PEMF) has been reported to be effective in reducing pain, healing of ulcers and promote bone healing, and treating osteoarthritis and inflammatory diseases of the musculoskeletal system. Also, it was reported that PEMF exposure significantly increases the anti-inflammatory effect, suggesting its potential therapeutic use in the treatment of inflammatory bone and joint disorders.

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
Double (Participant, Investigator)

入排标准

年龄范围
13 Years 至 16 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • type A hemophilia (moderate)
  • free from any musculoskeletal deformities.

排除标准

  • patients who performed surgical procedures 6 weeks before conducting the study

结局指标

主要结局

swelling

时间窗: basline and after 3 months of intervention.

The swelling degree was detected by tape

次要结局

  • range of motion(basline and after 3 months of intervention.)
  • muscle strength(basline and after 3 months of intervention.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

walaa eldesoukey heneidy

lecturer of physical therapy

Delta University for Science and Technology

研究点 (2)

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