Effects of the pulsed ultrasound on postural sway indices in women with knee osteoarthritis
Design
Randomized clinical trial, no blinding
Patients with knee osteoarthritis were randomly assigned to one of the three intervention groups by using sealed envelope
Settings and conduct
After initial evaluation and check the conditions of the inclusion and exclusion criteria by rheumatologist, patients were referred to Tarbiat Modares University for evaluation and interventional therapy. The venue of the research was in No. 2 Faculty of Medicine, Tarbiat Modares University, Tehran.
Participants/Inclusion and exclusion criteria
Primary symptomatic knee osteoarthritis for at least 6 months
Not having any contraindications for treatment with ultrasound (like cancer, wound, ...)
ُShould not present neuromuscular, musculoskeletal, chronic inflammatory disorders, diabetes or any other conditions that could affect the balance of the patients
Not having osteoporosis
Intervention groups
1) Placebo ultrasound plus exercise therapy group: 10 sessions of sham ultrasound with isotonic and isometric exercises of the lower limbs
2) Ultrasound group: 10 sessions of treatment with pulsed ultrasound
3) Ultrasound plus exercise therapy group: 10 sessions of treatment with pulsed ultrasound with performing isotonic and isometric exercises of the lower extremities
4) Healthy subjects group: Just make initial evaluations for comparison with patient groups
Main outcome variables
Center of Pressure Path Length
Center of Pressure displacement range
Center of Pressure displacement velocity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161015030306N2
Registration date:2018-03-19, 1396/12/28
Registration timing:retrospective
Last update:2018-03-19, 1396/12/28
Update count:0
Registration date
2018-03-19, 1396/12/28
Registrant information
Name
seyed mehdi mohsenipour
Name of organization / entity
tarbiat modares university
Country
Iran (Islamic Republic of)
Phone
+98 82880021
Email address
m.mohsenipour@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
tarbiat modares university
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
2016-04-03, 1395/01/15
Actual recruitment end date
2016-09-22, 1395/07/01
Trial completion date
empty
Scientific title
Effects of therapeutic ultrasound on postural sway indices in women with knee osteoarthritis
Public title
Effects of therapeutic pulsed ultrasound on balance in women with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primary symptomatic knee osteoarthritis for at least 6 months
Women between the ages of 40 and 73 years
No other treatments for 6 months prior to the study
Exclusion criteria:
No contraindications for treatment with ultrasound (like cancer, wound, ...)
Subjects should not present serious neurologic and systemic diseases, musculoskeletal or chronic inflammatory disorders, diabetes or any other conditions that could influence the balance of the patients
Not having osteoporosis
Age
From 40 years old to 73 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
Actual sample size reached:
38
Randomization (investigator's opinion)
N/A
Randomization description
Randomization with sealed envelopes. subjects pick up one envelope and enter one of the three groups of intervention by chance.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
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
Tarbiat Modares University, Nasr, Jalal e al e ahmad, Tehran
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2016-03-05, 1394/12/15
Ethics committee reference number
IR.TMU.REC.1394.249
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M15-M19
ICD-10 code description
In this block the term osteoarthritis is used as a synonym for arthrosis or osteoarthrosis. The term primary has been used with its customary clinical meaning of no underlying or determining condition identified.
Primary outcomes
1
Description
Center of Pressure path length, Center of Pressure displacement Range, Center of Pressure displacement velocity
Timepoint
Before intervention, 2 till 4 days after intervention
Method of measurement
Force plate
Secondary outcomes
1
Description
Pain, functional balance status
Timepoint
Before intervention. 2 till 4 days after intervention
Method of measurement
Visual Analogue Scale questionare, WOMAC questionare, Lequesne questionare, Timed Up and Go Test, 6 Minute Walk Test
Intervention groups
1
Description
Placebo ultrasound plus exercise therapy group: Advise plus off ultrasound plus exercise therapy. Ultrasound group: Advise plus pulsed ultrasound. Ultrasound plus exercise therapy group: Advise plus pulsed ultrasound plus exercise therapy. Healthy subjects group
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiatallh hospital
Full name of responsible person
Dr Nooshin Bayat, Rheumatologist, Professor of Baqiatallah University
Street address
Sheikh bahaei st, Mollasadra st, Vanak square
City
Tehran
Province
Tehran
Postal code
۱۴۳۵۹۱۵۳۷۱
Phone
+98 21 8805 0436
Email
Nobayat@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Vice head of research
Street address
No. 3 Faculty of Medicine, Tarbiat Modares University, Jalal e Al e Ahmad, Tehran.
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 2009
Fax
+98 21 8800 6544
Email
Res@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
Tarbiat Modares University
Full name of responsible person
Roya Ravanbod
Position
Ph.D of Physical Therapy, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
No 3 Faculty of medicine, Tarbiat Modares University, Jalal e Al e Ahmad
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3287
Fax
Email
rravanbod@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Seyed Mehdi Mohsenipour
Position
Msc student of physical therapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 3 Faculty of medicine, Tarbiat Modarwes University, Jalal e Al e Ahmad
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3287
Fax
Email
mohsenipour@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Roya Ravanbod
Position
Ph.D of physical therapy, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
No. 3 Faculty of medicine, Tarbiat Modares University, Jalal e Al e Ahmad
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3287
Fax
Email
rravanbod@hotmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
If the data would be necessary for a research, only after evaluation and permission from the vice head of research of Tarbiat Modares university
Study Protocol
Undecided - It is not yet known if there will be 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Data of the study includes postural sway indices, changes in pain and functional status. The data of major outcome is shareable and personal informations are not shareable.
When the data will become available and for how long
Access after the thesis defence
To whom data/document is available
Physiotherapy colleagues and other researchers
Under which criteria data/document could be used
For research and treatment purposes
From where data/document is obtainable
1) Seyed Mehdi Mohsenipour with electronic mail: Mohsenipour@hotmail.com
2) Roya Ravanbod with electronic mail: rravanbod@modares.ac.ir
What processes are involved for a request to access data/document
The applicant can access the data in one week by sending email to any of top electronic mails.