| 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
|
|
|
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
|
|
|
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. |