Designing and manufacturing of prayer knee brace in patients with mild knee osteoarthritis pain
Evaluation of the effect of prayer knee brace on pain in patients with mild knee osteoarthritis pain
Evaluation of the effect of prayer knee brace on Joint stiffness in patients with mild knee osteoarthritis pain
Evaluation of the effect of prayer knee brace on functional activity in patients with mild knee osteoarthritis pain
Evaluation of the effect of prayer knee brace on range of motion in patients with mild knee osteoarthritis pain
Design
Interventional study, without control group and blinding
Settings and conduct
The first stage is the design and manufacture of prayed knee brace.
In the second stage, participants filled the WOMAC questionnaire and the range of knee joint was measured by goniometer.
After 30 days use of knee brace the evaluation repeated.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Knee osteoarthritis Grade 3 and 4 (Kellgren-lawrence Grade) According to the orthopedic surgeon
Age between 30 - 60 years
Mild knee pain based on Visual Analog Scale
History of surgery associated with the disease (such as replacement and joint repair)
Exclusion criteria:
History of knee fracture
Chronic illness such as insulin-dependent diabetes or lupus
Corticosteroid injections into the knee joint during the 30 days prior to the intervention or the injection program until the end of the study period
Intervention groups
prayer knee brace are designed and manufactured for participant with knee pain due to knee osteoarthritis. This knee brace is light and does not prevent knee bending. The area of the petal is soft, and when kneeling, it prevents loading on the knee.
Main outcome variables
pain, joint stiffness, functional activity, range of motion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180619040148N2
Registration date:2019-05-01, 1398/02/11
Registration timing:prospective
Last update:2019-05-01, 1398/02/11
Update count:0
Registration date
2019-05-01, 1398/02/11
Registrant information
Name
Masumeh Bagherzadeh Cham
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1612
Email address
bagherzadehcham.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-20, 1398/03/30
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing, manufacturing and evaluating the effectiveness of prayer knee brace in patients with mild knee osteoarthritis pain
Public title
prayer knee brace
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Knee osteoarthritis Grade 3 and 4 (Kellgren-lawrence Grade) According to the orthopedic surgeon
Age between 30 - 60 years
Mild knee pain based on Visual Analog Scale
Exclusion criteria:
History of surgery associated with the disease (such as replacement and joint repair)
History of knee fracture
Chronic illness such as insulin-dependent diabetes or lupus
Corticosteroid injections into the knee joint during the 30 days prior to the intervention or the injection program until the end of the study period
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-07-29, 1397/05/07
Ethics committee reference number
IR.IUMS.REC.1397.419
Health conditions studied
1
Description of health condition studied
patients with mild knee osteoarthritis pain
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Pain rate when kneeling based on WOMAC questionnaire
Timepoint
Before intervention and 30 days after knee brace use
Method of measurement
WOMAC questionnaire (Western Ontario and McMaster osteoarthritis index)
2
Description
Joint stiffness
Timepoint
Before intervention and 30 days after knee brace use
Method of measurement
WOMAC questionnaire (Western Ontario and McMaster osteoarthritis index)
3
Description
Functional activity
Timepoint
Before intervention and 30 days after knee brace use
Method of measurement
WOMAC questionnaire (Western Ontario and McMaster osteoarthritis index)
4
Description
Range of motion
Timepoint
Before intervention and 30 days after knee brace use
Method of measurement
Digital goniometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: prayed knee brace. Light and thin knee brace that do not prevent knee bending. The anterior side of the knee brace is made of foam, which reduces knee forces when kneeling.
Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Masumeh Bagherzadeh Cham
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Firozgar Haspital, Behafarin St, Valiasr St
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1612
Fax
Email
BagherzadehCham.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masumeh Bagherzadeh Cham
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Firozgar Haspital, Behafarin St, Valiasr St
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1612
Fax
Email
BagherzadehCham.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masumeh Bagherzadeh Cham
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Firozgar Haspital, Behafarin St, Valiasr St
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1612
Fax
Email
BagherzadehCham.m@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after unidentifiable people
When the data will become available and for how long
starting one year after article publication
To whom data/document is available
Information is available to all researchers working in academic and scientific institutions
Under which criteria data/document could be used
use of data is only possible by mentioning the name and organizational affiliation of the correspond and co-author of the project and the published article.
From where data/document is obtainable
connect to Dr Masumeh Bagherzadeh Cham by email:
masumehbagherzadeh@gmail.com
What processes are involved for a request to access data/document
If information is used in scientific and therapeutic activities, information is provided as soon as possible.