The aim of this study is to compare the effects of routine physiotherapy with Pilates exercise on pain, function and quality of life in women with knee Osteoarthritis. In this study 20 women in the age range of 50 _70 years with knee Osteoarthritis will be selected by simple sampling and then randomly divided into control and intervention groups.Control group treated with 12 sessions of low-frequency TENS & hot pack for 20 minutes, continuous ultrasound for 5 minutes and exercise . Intervention group over 12 sessions treated with Pilates exercises . In this study, pain, function and quality of life of patients will be evaluated, respectively, by the VAS index , functional tests Timed Up and Go Test and 30 - second Chair Stand Test and SF _ 36 quality of life questionnaire, at the first session o and the last session of treatment
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604041552N6
Registration date:2016-07-02, 1395/04/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-02, 1395/04/12
Registrant information
Name
Maryam Ebrahimian
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1551
Email address
ebrahimian@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice- Chancellor for Research Affairs of Shiraz University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2017-03-18, 1395/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of routine physiotherapy and Pilates exercise on pain, function and quality of life in women with knee osteoarthritis
Public title
Comparison of the effects of routine physiotherapy and Pilates exercise on pain, function and quality of life in women with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with knee osteoarthritis , age range 50_70 years old; have a pain in the range of 30_70 mm based on the VAS, score 2 or 3 of standard Modified Altman.
Exclusion criteria: have been experienced physiotherapy or exercise therapy in the past 6 months; history of joint tap or steroid injection in the last year; active inflammation of the knee; pain at the hip and ankle; history of fracture or dislocation of lower limbs; any deformities in the lower extremitiesl; osteoporosis based on the criteria of T-Score (T≤ -2.5); history of systemic, immune system, cardiovascular diseases.
Age
From 50 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Shiraz University of Medical Sciences
Street address
In front of Felestin Street, Zand Avenue
City
Shiraz
Postal code
1433671348
Approval date
2016-03-06, 1394/12/16
Ethics committee reference number
IR.SUMS.REC.1394.214
Health conditions studied
1
Description of health condition studied
Osteoarthritis of knee
ICD-10 code
M17
ICD-10 code description
Gonarthrosis [arthrosis of knee]
Primary outcomes
1
Description
pain
Timepoint
Before and after treatment sessions
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
function
Timepoint
Before and after treatment sessions
Method of measurement
timed up and go test and 30 second chair stand test
2
Description
quality of life
Timepoint
Before and after treatment sessions
Method of measurement
SF39 questionnaire
Intervention groups
1
Description
Control group treated with 12 ( 4 weeks ,3 sessions ) sessions of low-frequency TENS & hot pack for 20 minutes, continuous ultrasound treatment for 5 minutes and exercise
Category
Rehabilitation
2
Description
Intervention group over 12 sessions ( 4 weeks ,3 sessions ) treated with Pilates exercises
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation Sciences School of Shiraz University of Medical Sciences
Full name of responsible person
Mahsa Zahedi
Street address
Abiverdi No.1 St., Shahid Chamran Blvd.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice- Chancellor for Research Affirs of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
7th fioor of Central Building of Shiraz University of Medi cal Sciences,In front of Felestin Street, Zand Avenue
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice- Chancellor for Research Affirs of Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Rehabilitation Sciences School of Shiraz University of Medical Sciences
Full name of responsible person
Mahsa Zahedi
Position
Bachelor of Science Student
Other areas of specialty/work
Street address
Abiverdi No.1 St., Shahid Chamran Blvd.
City
Shiraz
Postal code
7194733669
Phone
+98 71 3627 1551
Fax
Email
mhs.zahedi72@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rehablitation Sciences School of Shiraz Univercity of Medical Sciences
Full name of responsible person
Maryam Ebrahimian
Position
Master of Science/ Faculty Member
Other areas of specialty/work
Street address
Abiverdi No.1 St., Shahid Chamran Blvd
City
Shiraz
Postal code
7194733669
Phone
+98 71 3627 1551
Fax
+98 71 3627 2495
Email
ebrahimian@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rehabilitation Sciences School of Shiraz University of Medical Sciences
Full name of responsible person
Mahsa Zahedi
Position
Bachelor of Science Student
Other areas of specialty/work
Street address
Abiverdi No.1 St., Shahid Chamran Blvd.
City
Shiraz
Postal code
7194733669
Phone
+98 71 3627 1551
Fax
+98 36272495
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)