The effects of Isometric exercise of vastus medialis oblique Muscle; with and without electromyographic biofeedback on voluntary muscle activity, maximal muscle thickness,pain and function in patients with knee osteoarthritis
This study is designed to compare the effect of isometric exercise of vastus medialis oblique muscle with and without electromyographic biofeedback in voluntary muscular activity, maximal muscle thickness, clinical symptoms and activity of daily living (ADL) in patients with knee osteoarthritis. Knee osteoarthritis is the most common joint disease, but despite a variety of non-surgical procedures, so far there is no general consensus on the priority of treatment. This study is a single-blind randomized controlled clinical trial on 41 patients with mild to moderate osteoarthritis who come to shahid Moddares Hospital. Patients with pain or joint swelling and radiologic findings of joint destruction since 6 months ago based on knee osteoarthritis criteria of The ACR (grade 2, 1 of Kellgren-Lawrence scale ) will be recruited. Exclusion criteria are patients under treatment of corticosteroid usage and etc. In one group 12 sessions isometric exercise of vastus medialis oblique muscle with biofeedback, and 12 sessions exercise without feedback in other group will be done.Voluntary muscular activity with biofeedback device, maximal muscle thickness with ultrasonography, Pain, function, maximum distance walking and ADL will be measured through WOMAC and Lequesne questionnaires before and 2 months after exercise in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041513442N14
Registration date:2017-06-01, 1396/03/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-01, 1396/03/11
Registrant information
Name
Seyed Ahmad Raeissadat
Name of organization / entity
Modares Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 1112
Email address
a_raeissadat@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-01-01, 1394/10/11
Expected recruitment end date
2016-06-01, 1395/03/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Isometric exercise of vastus medialis oblique Muscle; with and without electromyographic biofeedback on voluntary muscle activity, maximal muscle thickness,pain and function in patients with knee osteoarthritis
Public title
Effect of Biofeedback on Knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: arthralgia since the past 6 months; radiologic evidence of articular damage (grade 2,1 of Kellgren-Lawrence scale) based on knee OA criteria of ACR. Exclusion criteria: systemic diseases such as diabetes mellitus and collagen vascular disorders; history or presence of cancer or malignant disorders; any infection and active wound of the knee; presence of immunosuppressive, autoimmune disorders; recent history of severe trauma to the knee; age less than 45 or over 70 year; genu valgum/varum greater than 20 degrees.
Age
From 51 years old to 26 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
41
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committe Of, Shahid Beheshti University Of Medical Siences
Street address
Ethic Committe Of Shahid Beheshti University Of Medical Siences, Velenjak, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-10-23, 1395/08/02
Ethics committee reference number
IR.SBMU.MSP.REC.1395.344
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis (Gonarthrosis)
ICD-10 code
M17.0
ICD-10 code description
Gonarthrosis [arthrosis of knee]
Primary outcomes
1
Description
pain
Timepoint
at the beginning and after 2 months
Method of measurement
womac,Lequesne questionnaire
2
Description
joint stiffness
Timepoint
at the beginning and after 2 months
Method of measurement
womac questionnaire
3
Description
functional limitation
Timepoint
at the beginning and after 2 months
Method of measurement
womac questionnaire
4
Description
walking ability
Timepoint
at the beginning and after 2 months
Method of measurement
Lequesne questionnaire
5
Description
activities of daily living
Timepoint
at the beginning and after 2 months
Method of measurement
Lequesne questionnaire
6
Description
Voluntary muscular activity
Timepoint
at the beginning and after 2 months
Method of measurement
biofeedback device
7
Description
maximal muscle thickness
Timepoint
at the beginning and after 2 months
Method of measurement
sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 12 sessions isometric exercise of vastus medialis oblique muscle with electromyographic biofeedback
Category
Rehabilitation
2
Description
Intervention group 2: 12 sessions isometric exercise of vastus medialis oblique without feedback
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Zeynab Bossaghzade
Street address
Shahid Modarres Hospital, Kaj Square, Saadat Abad Street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Physical Medicine and Rehabilitation Department of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Seyed Ahmad Raeissadat
Street address
Physical Medicine and Rehabilitation Departement, Shahid Modarres Hospital, Kaj Square, Saadat Abad, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physical Medicine and Rehabilitation Department of Shahid Beheshti 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
Shahid Beheshti Univeraity of Medical Sciences
Full name of responsible person
Zeynab Bossaghzade
Position
Resident in Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Shahid Modarres Hospital, Kaj Square, Saadat Abad Street, Tehran
City
Tehran
Postal code
Phone
+98 21 2273 1112
Fax
Email
zeynabbossaghzade@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Univeraity of Medical Sciences
Full name of responsible person
Seyed Ahmad Raeissadat
Position
Associate Professor
Other areas of specialty/work
Street address
Shahid Modarres Hospital, Kaj Square, Saadat Abad Street, Tahran
City
Tehran
Postal code
Phone
+98 21 2207 4090
Fax
Email
a_raeissadat@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti Univeraity of Medical Sciences
Full name of responsible person
Zeynab Bossaghzade
Position
Resident in Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Shahid Modarres Hospital, Kaj square, Saadat Abad street, Tehran
City
Tehran
Postal code
Phone
+98 21 2207 4090
Fax
Email
zeynabbossaghzade@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)