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Comparing the effectiveness of magnet therapy ,acupuncture and isometric exercise in patients with chronic and moderate knee osteoarthritis.

Protocol summary

Study aim
Comparing the effectiveness of magnet therapy ,acupuncture and isometric exercise in patients with chronic and moderate knee osteoarthritis
Design
Three arm parallel group design sixty patients,non -randomised ,non blinded,clinical trial
Settings and conduct
Three groups patients ,in each group twenty patients , thorough physician's opinion and days of week that patients refer to clinic,they have divided in three groups.each group under treatment with magnet therapy ,acupuncture or isometric exercise for six weeks in physical medicine and rehabilitation clinic of baqiyatallah hospital,and before first session of treatment and two months after termination of treatment western Ontario and McMaster universities in knee osteoarthritis (WOMAC ) and visual analogue scale (VAS) questionnaires were filled.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:knee osteoarthritis grade 2,ROM at least 100 degree,age between 45 - 65 years,history knee osteoarthritis at least 3 years,bilateral knee osteoarthritis Exclusion criteria:acute injury,advanced knee osteoarthritis,infection in injection site,history previous treatment such as corticosteroids,NSAIDS,supplements,magnet therapy ,acupuncture and massage in 3 -6 months ago,history febrile or infectious disease or patient s disagreement,patients with pace maker or any metal device in the body,chronic and malignant disease
Intervention groups
Three groups ,in each group twenty patients,each group under treatment with magnet therapy and isometric exercise,acupuncture and isometric exercise and isometric exercise , through physician's opinion and days of week that they have referred to clinic.patients in isometric exercise group are in the cotrol group of this study.
Main outcome variables
pain severity,range of motion.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181017041371N1
Registration date: 2019-01-06, 1397/10/16
Registration timing: retrospective

Last update: 2019-01-06, 1397/10/16
Update count: 0
Registration date
2019-01-06, 1397/10/16
Registrant information
Name
Fayeze Hakimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2252 5793
Email address
fa.hakimi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of magnet therapy ,acupuncture and isometric exercise in patients with chronic and moderate knee osteoarthritis.
Public title
Magnet therapy ,acupuncture and isometric exercise in treatment knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Knee osteoarthritis grade 2 Range of motion knee at least 100 degree Age between 45 to 65 years old History knee osteoarthritis at least 3 years Bilateral knee osteoarthritis
Exclusion criteria:
History acute knee injury Advanced knee osteoarthritis Infection in injection site History treatment with corticosteroids,NSAIDS,supplements ,magnet therapy,acupuncture and massage in 3-6 months ago History intra-articular injection in 3-6 months ago History of infectious or febrile disease,disagreement of patients Patients with pace maker or metal device in body Chronic disease such as heart,lung,liver,renal diseases,malignant tumors,active bleeding
Age
From 45 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
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 baqiyatallah University of medical science
Street address
Sheikh bahaei Ave,Vanak square
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2018-04-16, 1397/01/27
Ethics committee reference number
IR.BMSU.REC.1397.051

Health conditions studied

1

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

Primary outcomes

1

Description
western Ontario and McMaster universities osteoarthritis index(Womac score(knee)
Timepoint
Before initiation treatment and 2 months after termination treatment
Method of measurement
Womac score

2

Description
pain severity
Timepoint
Before initiation treatment and 2 months after termination treatment
Method of measurement
visual analogue score(VAS)

3

Description
range of motion
Timepoint
Before initiation treatment and 2 months after termination treatment
Method of measurement
Goniometer

Secondary outcomes

empty

Intervention groups

1

Description
In this study isometric exercise has been done for all patients.first group that only recieve isometric exercise are control group of this study.
Category
Treatment - Other

2

Description
in patients in Intervention group1: magnet therapy with magnotherap (2 channel magnet +2 channel multi stimulator 3 session 30 minutes weekly for 6 weeks in 10th protocol magnetic device ,in 30 minutes and intensity 35 and simultaneously isometric exercise 3 sessions 30 minutes or 6 sessions 15 minutes weekly for 6 weeks has been done.
Category
Treatment - Other

3

Description
Intervention group: in patients that they are in intervention group 2 acupuncture 3 session 30 minutes weekly for 6 weeks (18 sessions 30 minutes) and simultaneously isometric exercise 3 sessions 30 minutes weekly or 6 sessions 15 minutes weekly for 6 weeks has been done.in patients who are in control group for isometric exercise 3 sessions weekly for 30 minutes or 6 sessions15 minutes weekly for 6 weeks has been done.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah hospital
Full name of responsible person
Fayeze Hakimi
Street address
Sheikh bahaei Ave.,Vanak square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 2365
Email
fa.hakimi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Gholamhossein Alishiri
Street address
Sheikh Bahaei Ave,Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 2365
Email
r.bmsu@yahoo.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
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Fayeze Hakimi
Position
resident of physical medicine and rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No. 12 , Salimi Alley, Amir Kianoush street , Mellat Square , North Majidie
City
Tehran
Province
Tehran
Postal code
۱۶۶۵۹۸۶۱۸۳
Phone
+98 21 2252 5793
Email
fa.hakimi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mahsa Asheghan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Nosrati Alley,sheykh bahaei st,Mollasadra st,Vanak sq,tehran,iran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 2365
Email
mahsaasheghan@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Fayeze Hakimi
Position
resident physical medicine and rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No . 12 ,Salimi Alley , Amir Kianoush street, Mellat square, North Majidie
City
Tehran
Province
Tehran
Postal code
1665986183
Phone
+98 21 2252 5793
Email
t.khanali@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
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
Accessibility to all information is possible
When the data will become available and for how long
Immediately after published
To whom data/document is available
Everyone
Under which criteria data/document could be used
Without any limitations
From where data/document is obtainable
Fayeze Hakimi fa.hakimi@yahoo.com
What processes are involved for a request to access data/document
With email ,about 2 days
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