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Designing and evaluating an educational package on pain management in women with osteoarthritis of the knee near menopause

Protocol summary

Study aim
Design and evaluation of an educational package on pain management in women with osteoarthritis of the knee
Design
A clinical trial with intervention and control groups
Settings and conduct
Self-report of Kohgiluyeh and Boyer-Ahmad provinces of Yasuj city
Participants/Inclusion and exclusion criteria
Inclusion criteria: age around menopause (40-55), people with moderate knee pain, having knee pain for three months or more (chronic pain), dry knee when sitting and standing, no history of trauma, injury or surgery and lower limb fractures in the last 6 months, those who have not been previously trained in protective behaviors, have at least a basic education. Exclusion criteria: Joint surgery, joint replacement, intra-articular injection in 6 months, age over 55, knee joint infections, oral administration of corticosteroids for 6 weeks (current or past ), Any other disease that affects the function of the lower limbs, the patient does not participate in one of the training sessions, women with musculoskeletal disabilities (due to restrictions in performing therapeutic exercise movements).
Intervention groups
The intervention and control group included fifty women between the ages of 40 and 55 who had grade 2 or 3 knee osteoarthritis.
Main outcome variables
Protective behaviors, muscle strength, pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220105053636N1
Registration date: 2022-02-05, 1400/11/16
Registration timing: registered_while_recruiting

Last update: 2022-02-05, 1400/11/16
Update count: 0
Registration date
2022-02-05, 1400/11/16
Registrant information
Name
masoomeh dashtian
Name of organization / entity
Tarbiat Modares
Country
Iran (Islamic Republic of)
Phone
+98 21 82880
Email address
m.dashtyan@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-20, 1399/09/30
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing and evaluating an educational package on pain management in women with osteoarthritis of the knee near menopause
Public title
Designing and evaluating an educational package on knee pain management in women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Menopausal age (40-55) - People with moderate knee pain - Knee pain for three months or more (chronic pain) - Dry knee when sitting and standing, No history of trauma - Injury or surgery and Lower limb fractures in the last 6 months - those who have not previously been trained in protective behaviors - have at least a basic education
Exclusion criteria:
Joint surgery, joint replacement, intra-articular injection at 6 months, age over 55, knee joint infections, oral administration of corticosteroids for 6 weeks (present or past), any other disease that affects lower limb function, no participation The patient in one of the training sessions, women with musculoskeletal disabilities (due to limitations in performing therapeutic exercise movements).
Age
From 40 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
For each group, 44 people in each group are determined and finally, according to the probability of reduce sample, 50 people are considered for each group. A total of 100 people will enter this phase of the study for the two study groups (an intervention group and a control group). Cluster sampling was used in this study. For this purpose, first each of Yasuj treatment clinics is considered as a cluster and then we randomly assign one of the clinics to the intervention group and select the other as a control center. . After listing the names of all women in each medical center, we randomly select people who are eligible and interested in participating in the study to provide the required number, which was calculated based on the sampling formula
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of Tarbiat Modares University
Street address
No. 7, Jalal Al-Ahmad St.
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2019-09-12, 1398/06/21
Ethics committee reference number
IR.MODARES.REC.1398.101

Health conditions studied

1

Description of health condition studied
knee osteoarthritis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
1- Protective behaviors 2- Muscle strength 3- Pain
Timepoint
Before, immediately and six months after the study
Method of measurement
Using a questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group will be evaluated based on the design of a randomized controlled trial intervention.In this study, the intervention group includes 50 women who are eligible to enter the study. Educational intervention program based on high-risk behaviors in the interview section and the results of the checklist of knee protection behaviors.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
کلینیک های درمانی شهید مفتح و کلینیک درمانی فیزیوتراپی
Full name of responsible person
معصومه دشتیان
Street address
Tehran, Jalal Al-Ahmad St., Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 4547
Email
dashtyanmasoome@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
yaghoub fatolahi
Street address
Tehran, Jalal Al-Ahmad St., Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 2009
Email
fatolahi@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Health Education Branch, Faculty of Medical Sciences, Tarbiat Modares University
Full name of responsible person
sedighe sadat tavafian
Position
Professor of health education and health promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Jalal Al-Ahmad St. Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 4547
Email
tavafian@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University, School of Health, Health Education Branch
Full name of responsible person
sedigheh sadat tavafian
Position
Professor of Health Education
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Jalal Al-Ahmad St. Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 4547
Email
tavafian@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
masoume dashtian
Position
student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Jalal Al-Ahmad St., Tarbiat Modares University
City
tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 4547
Email
dashtyanmasoome@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
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
I have no decision at the moment
When the data will become available and for how long
31/6/1401
To whom data/document is available
The person evaluating the outcome of the person analyzing the referee's magazine
Under which criteria data/document could be used
Evaluate the outcome of data analysis and check the accuracy of the data under double-blind conditions
From where data/document is obtainable
executor of plan
What processes are involved for a request to access data/document
Requested via email to the project manager with the address: tavafian@modares.ac.ir
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