1- Comparison of pain before and after intervention in two groups of intervention and control.
2- Comparison of pain intensity before and after intervention in two groups of intervention and control.
3- Comparison of dry joints before and after intervention in intervention and control groups.
4. Comparison of physical function before and after intervention in two groups of intervention and control.
5- Comparison of pre-and post-intervention drug use in both intervention and control groups.
Design
The sample size is based on Table B.12 1 for the comparison of the mean of the three independent groups (control, conventional treatment, acupressure).
Settings and conduct
Samples were collected from patients referring to the Imam Khomeini Hospital clinic as well as orthopedic clinics. Following the training, weekly follow up is done on the intervention and the results.
Participants/Inclusion and exclusion criteria
1- The severity of the pain in the knee is based on a scale of over 3.
2. Not using other complementary therapies or relaxation techniques such as yoga and relaxation and ...
3. No knee injury that prevents acupressure in that area
4. Failure to develop a disease of rheumatoid arthritis or lupus that may cause symptoms such as osteoarthritis.
Intervention groups
Patients are randomly assigned into three independent groups (control and conventional therapy and acupressure). The training is given to the intervention group during the same session in person.
The acupressure training is also given to the control group, with the difference that we introduce the pressure points at a distance of 1 cm from the main points. At the end of the study, acupressure training will be given to the control group..
Main outcome variables
Acupressure; pain; pain intensity; physical function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181217042032N1
Registration date:2019-03-09, 1397/12/18
Registration timing:registered_while_recruiting
Last update:2019-03-09, 1397/12/18
Update count:0
Registration date
2019-03-09, 1397/12/18
Registrant information
Name
Lale Raygan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3337 7864
Email address
raygan.l@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of self- acupressure on the pain and physical function of patients with knee osteoarthritis
Public title
The effect of acupressure on osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age group 50-70 years
Diagnosis of knee osteoarthritis by orthopedics or physical medicine
Sudden acute pain in the patient based on high and high scales.
Not using other therapeutic or tranquil methods such as relaxation such as yoga and relaxation and ...
Lack of knee injury that prevents surgical procedures in that area
Non-development of rheumatoid arthritis or liposoma that shows symptoms like osteoarthritis
Ability to learn and implement intervention.
Exclusion criteria:
Need surgery during intervention.
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning intervention to individuals was randomized and random blocked blocks with a block size of 6 according to the objectives of the study, the researcher's opinion, previous studies and taking into account the parameters α = 0.01, power = 0.9 and (low difference) The highest and most mean score of pain was calculated based on Womac = Δ and standard deviation of pain score =).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
No 69 ; west 17 Ave; kianpars
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۵۵۸۸۷۸۸۸
Approval date
2018-10-20, 1397/07/28
Ethics committee reference number
IR.AJUMS.REC.1397.539
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Percentage of physical function of patients with knee osteoarthritis based on womak questionnaire
Timepoint
The beginning of the study; 4 weeks after the start of the study and 8 weeks after the start of the study
Method of measurement
visual Analogue Scale . Womak
Secondary outcomes
1
Description
Patient Physical Performance Score
Timepoint
Beginning of study. 4 weeks after the start of the study and 8 weeks after the start of the study
Method of measurement
Visual Analogue Scale - Womak questionnaire
Intervention groups
1
Description
Intervention group: In this group, acupressure intervention is taught to patients on 5 specific points around the knee and patients are asked to take interventions every day on the trained points. The assessment will be performed on the start of the study and 4 weeks after the start and 8 weeks after the start of the study.
Category
Rehabilitation
2
Description
Intervention group: Intervention group training is also given to this group, with the difference that the acupressure points are introduced and trained by a 1 cm difference.
Category
Rehabilitation
3
Description
Control group: This group is without training and in the same conditions as before entering this study.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Imam Khomeini Hospital
Full name of responsible person
Laleh Raygan
Street address
24 meters high street. Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6155887888
Phone
+98 61 3337 7864
Email
www.l.raygan79@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
mojgan javad noory
Street address
Golestan Main Blvd. Jundishapur University
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3337 7864
Email
l.raygan79@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Laleh Raygan
Position
Senior Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 69. West 17th Street. Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6158887888
Phone
+98 61 3337 7864
Email
www.l.raygan79@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Laleh Rayegan
Position
Senior Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
no 69. West 17th Street.Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155887888
Phone
+98 61 3337 7864
Email
www.l.raygan79@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Laleh Rayegan
Position
Senior Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 69. West 17th Street. Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
61588887888
Phone
+98 61 3337 7864
Email
www.l.raygan79@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data of the participants will be shared after unauthorized identification.
When the data will become available and for how long
Get started since 1400
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
If used and completed, research is available.
From where data/document is obtainable
www. l.raygan79@gmail.com
What processes are involved for a request to access data/document
Approximately 2-3 weeks after receiving the email.