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临床试验/CTRI/2021/03/031836
CTRI/2021/03/031836已完成不适用

Effectiveness of Myofascial therapy and conventional physiotherapy with intermittent prophylaxis on Joint Health in Haemophilic Arthropathy- A Randomized Control Trial

World Federation of Haemophilia1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年3月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
WFH Gilbert Score

研究概览

简要总结

Haemophilia is an X-linked recessive hereditary bleeding disorder which occurs due to deficiency of coagulation factors VIII and IX in the body. Their incidence ranges from 8 to 20 and 1 to 8 for every 100000 male patients, respectively depending on the geographical area. The best treatment to prevent the recurrent haemarthrosis and haemophilic arthropathy is the standard infusion of FVIII or FIX concentrates in the form of continuous prophylactic treatment.  However, the initial few bleeds and cause further joint damage due to iron deposition leading to inflammation, proliferation of synovium and neovascularization leading to a vicious cycle of bleed begetting bleeds.  This will in turn lead to muscle atrophy and instability of joint further aggravating the situation.   Along with prophylactic factor support, physiotherapeutic exercises are helpful in hemophilic joint arthropathies and prevent this ongoing damage.

Myofascial therapy is a type of manual therapy which aids in reducing the fibrous adhesions between different layers of the fascial tissue.  It includes mobilization of soft tissues including the fascial complex using various direct and indirect techniques. These techniques include the application of a low load long duration mechanical force specifically guided to manipulate the myofascial complex. The purpose of myofascial therapy is to reduce pain, improve tissue mobility and function. Conventional physiotherapy exercises are effective in decreasing the frequency of joint bleeds. However, when combined with manual therapy techniques such as Myofascial therapy, it can give an added advantage in improving joint health.

Although there is a high prevalence of haemophilic joint arthropathies these are often under treated. There is paucity of literature focusing on treatment specific for arthropathies. Thus, our study aims to find out the effectiveness of Myofascial therapy and prophylactic factor support along with conventional physiotherapy treatment on Joint Health in Haemophilic Arthropathy.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Male

入选标准

  • Patients diagnosed with Haemophilia A or B Patients with haemophilic arthropathy with at least one target joint involvement (elbow or knee) Patients above 18 years of age.

排除标准

  • Patients diagnosed with any other congenital bleeding disorders i.e. Von Willebrand disease.
  • Patients receiving regular physiotherapy for elbow or knee joint(s) prior to commencement of study.
  • Patients with any fixed deformity of knee or elbow joint(s).
  • Patients who have undergone elbow/knee synovio arthesis within last 6 months.
  • Patients who do not give informed consent.

结局指标

主要结局

WFH Gilbert Score

时间窗: Baseline Day 0 | Midterm Day 10 | Post Intervention Day 21 | Follow up at 3 months

次要结局

  • Range of Motion for Knee and Elbow Joint (using Goniometer)(Baseline Day 0)
  • Manual Muscle Testing using hand held Dynamometer(Baseline Day 0)
  • Haemophilia Joint Health Status (HJHS)(Baseline Day 0)
  • Functional Independence Scoring for Haemophilia (FISH)(Baseline Day 0)
  • EQ-5D-5L(Baseline Day 0)

研究者

发起方
World Federation of Haemophilia
申办方类型
Other [World Bleeding Disorders Registry]

研究点 (1)

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