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CTRI Number  CTRI/2021/03/031836 [Registered on: 09/03/2021] Trial Registered Prospectively
Last Modified On: 17/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to see how effective is Myofascial therapy, conventional Physiotherapy along with factor support to improve condition of joints in Haemophilia Patients. 
Scientific Title of Study   Effectiveness of Myofascial therapy and conventional physiotherapy with intermittent prophylaxis on Joint Health in Haemophilic Arthropathy- A Randomized Control Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M Joseph John 
Designation  Professor and Head 
Affiliation  Christian Medical College and Hospital, Ludhiana 
Address  Department of Clinical Haematology, Haemato-Oncology and BMT, Christian Medical College and Hospital, Brown Road, Ludhiana- 141008, India

Ludhiana
PUNJAB
141008
India 
Phone  8054959525  
Fax    
Email  mjosephjohn@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M Joseph John 
Designation  Professor and Head 
Affiliation  Christian Medical College and Hospital, Ludhiana 
Address  Department of Clinical Haematology, Haemato-Oncology and BMT, Christian Medical College and Hospital, Brown Road, Ludhiana- 141008, India

Ludhiana
PUNJAB
141008
India 
Phone  8054959525  
Fax    
Email  mjosephjohn@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mridul Makkar 
Designation  Physiotherapist and Research Coordinator 
Affiliation  Christian Medical College and Hospital, Ludhiana 
Address  Department of Clinical Haematology, Haemato-Oncology and BMT, Christian Medical College and Hospital, Brown Road, Ludhiana- 141008, India

Ludhiana
PUNJAB
141008
India 
Phone  7009359857  
Fax    
Email  mridulmakkar24@gmail.com  
 
Source of Monetary or Material Support  
World Federation of Haemophilia 1425, boul. René-Lévesque Ouest, bureau 1200 Montréal, Québec H3G 1T7 Canada 
 
Primary Sponsor  
Name  World Federation of Haemophilia 
Address  1425, boul. René-Lévesque Ouest, bureau 1200 Montréal, Québec H3G 1T7 Canada 
Type of Sponsor  Other [World Bleeding Disorders Registry] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr M Joseph John  Christian Medical College and Hospital, Ludhiana  Department of Clinical Haematology, Haemato-Oncology and BMT Brown Road Ludhiana PUNJAB 141008 India
Ludhiana
PUNJAB 
8054959525

mjosephjohn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Christian Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D67||Hereditary factor IX deficiency, (2) ICD-10 Condition: D66||Hereditary factor VIII deficiency,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Physiotherapy along with Intermittent Factor Prophylaxis  Conventional Physiotherapy (4 sessions per week for 3 weeks) and intermittent prophylaxis (Twice weekly for FVIII, Once Weekly for FIX) 
Intervention  Myofascial Therapy and Conventional Physiotherapy along with Intermittent Factor Prophylaxis  Conventional Physiotherapy (4 sessions per week for 3 weeks) along with Myofascial Therapy (2 sessions per week for 3 weeks) and intermittent prophylaxis (Twice weekly for FVIII, Once Weekly for FIX) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  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
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
WFH Gilbert Score  Baseline Day 0
Midterm Day 10
Post Intervention Day 21
Follow up at 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Range of Motion for Knee and Elbow Joint (using Goniometer)  Baseline Day 0
Midterm Day 10
Post Intervention Day 21
Follow up at 3 months 
Manual Muscle Testing using hand held Dynamometer  Baseline Day 0
Midterm Day 10
Post Intervention Day 21
Follow up at 3 months 
Haemophilia Joint Health Status (HJHS)   Baseline Day 0
Midterm Day 10
Post Intervention Day 21
Follow up at 3 months 
Functional Independence Scoring for Haemophilia (FISH)  Baseline Day 0
Midterm Day 10
Post Intervention Day 21
Follow up at 3 months 
EQ-5D-5L  Baseline Day 0
Midterm Day 10
Post Intervention Day 21
Follow up at 3 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "31"
Final Enrollment numbers achieved (India)="31" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/03/2021 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Makkar, M., Dhinakaran, M. S., Shukla, P., Sarwan, D., Ojha, S., & John, M. J. (2025). Effectiveness of myofascial therapy (MFT) along with traditional physiotherapy and intermittent prophylaxis on short-term improvement of joint health in hemophilic arthropathy: a randomized control trial. Expert Review of Hematology, 18(6), 471–479. https://doi.org/10.1080/17474086.2025.2495674 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

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. 
 
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