The effect of pulsed electromagnetic fields on clinical symptoms and quality of life in the patients with knee hemophilic arthropathy
Design
This study is a single blinded randomized controlled trial with parallel group. Sampling method is simple probability and grouping method is based on simple randomized allocation method (using random-numbers table method) and the sample size is 40 hemophila patients.
Settings and conduct
The study will be done in Isfahan province hemophilia center.
The volunteers will be examined by a specialist and will be included in the study if they have defined inclusion criteria. Then, they will be referred to the radiologist to determine the severity of the knee joint hemophilic arthropathy, then the subjects randomly will be divided into treatment and control groups.The treatment group receives pulsed electromagnetic field for one hour, and the control group is placed under the same program while the device is turned on and the output is zero. Knee clinical symptoms and quality of life of the patients will be measured before and after 18 sessions by a physiotherapist.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. The men with severe hemophilia A
2. The age range should be 20-40 years
3. Having at least one knee joint with active synovitis
Exclusion criteria
1. Having a body mass index more than 30 kg/m2
2. Having a heart pacemaker
Intervention groups
Intervention group: Pulsed electromagnetic field for one hour
Control group: Pulsed electromagnetic field while the output of the device is zero for one hour
Main outcome variables
Knee joint clinical symptoms; Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180716040488N1
Registration date:2018-09-26, 1397/07/04
Registration timing:retrospective
Last update:2018-09-26, 1397/07/04
Update count:0
Registration date
2018-09-26, 1397/07/04
Registrant information
Name
Azam Khami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3237 3579
Email address
khami@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-11, 1397/05/20
Expected recruitment end date
2018-09-16, 1397/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Pulsed Electromagnetic Field on clinical evaluation and quality of life of patient with knee hemophilic arthropathy
Public title
Effect of Magnet on clinical evaluation and quality of life in knee hemophilic arthropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men with severe hemophilia A
Having at least one knee joint with active synovitis
The Pettersson radiographic score of patients should be 5-9
The age range should be 20-40 years
Exclusion criteria:
Body Mass Index > 30 kg/m2
Having a heart pacemaker
Having a history of surgery or intra-articular injection of the knee in the last 6 months
Performing knee physiotherapy in the past month
Performing knee joint replacement therapy
Age
From 20 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are selected using the simple random method. The participants are randomly divided into two equal groups by random-numbers table.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants are not aware of the electromagnetic device being on and off.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Next to Ayatolah Taleghani Hospital, Shahid Arabi Street, Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-09-25, 1397/07/03
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.547
Health conditions studied
1
Description of health condition studied
Hemophilic arthropaty in hemophilia Patients
ICD-10 code
D66
ICD-10 code description
Hereditary factor VIII deficiency
Primary outcomes
1
Description
The Score of Hemophilia joint Health Score (HJHS) questionnaire
Timepoint
At the beginning and end of the study
Method of measurement
Hemophilia Joint Health Score (HJHS) questionnaire
2
Description
The score of the quality of life questionnaire A36 Hemofilia -Qol
Timepoint
At the beginning and end of the study
Method of measurement
Using a quality of life questionnaire A36 Hemofilia -Qol
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with knee joints exposed to Pulsed Electromagnetic Field, for 60 minutes, at frequencies of 2 Hz and 70 Hz
Category
Treatment - Devices
2
Description
Control group: Patients with knee joints exposed to Pulsed Electromagnetic Field، for 60 minutes، at frequencies of 2 Hz and 70 Hz while the output of the device is zero
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Esfahan hemophilia center
Full name of responsible person
Malihe Afzali
Street address
No 196, Nahid Dead End, Next to Footbridge, In front of Seyedo shohada Hospital, Motahari Street
City
Esfahan
Province
Isfehan
Postal code
8184914711
Phone
+98 31 3235 4343
Fax
+98 31 3235 4343
Email
infohemofilia1377@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Akbarzadeh Baghbane
Street address
Opposite to Booali Hospital, Damavand Ave,Shaheed Bakhshifard St. School of Rehabilitation
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Fax
+98 21 7759 1807
Email
roosta@sbmu.ac.ir
Web page address
http://rehab.sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Khami
Position
MSc
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Opposite to Booali Hospital, Damavand Ave,Shaheed Bakhshifard St. School of Rehabilitation
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 913 226 2177
Fax
+98 21 7759 1807
Email
Khamiazam@gmail.com
Web page address
http://rehab.sbmu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Mohsen Roostayi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Opposite to Booali Hospital, Damavand Ave,Shaheed Bakhshifard St. School of Rehabilitation
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Fax
+98 21 7759 1807
Email
roosta@sbmu.ac.ir
Web page address
http://rehab.sbmu.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Khami
Position
Master of science
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Apartment 4, Plate No.22, Bagh-janat Alley, Abouzar Street, Abbas Abad Street
City
Esfahan
Province
Isfehan
Postal code
8133746851
Phone
+98 31 3237 3579
Email
khamiazam@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
demographic information of participants
When the data will become available and for how long
After the end of the study
To whom data/document is available
Investigators
Under which criteria data/document could be used
For checking the accuracy of the study, and also, design of other studies
From where data/document is obtainable
Scientific manager of the study
What processes are involved for a request to access data/document