The aim of this study is to compare the effect of Dexamethasone phonophoresis versus ultrasound therapy in knee Osteoarthritis. In a randomized unicentral clinical trial, 60 patients from both genders with knee Osteoarthritis referring to physiotherapy clinic of Shohada hospital, Tabriz, Iran, will be randomly assigned to receive half dose Dexamethasone (4 mg) phonophoresis or be treated with 10 sessions of ultrasound each session for 10 minutes 3 times per week. Key inclusion criteria are to have mild to moderate Osteoarthritis; to be over 50 years old and key exclusion criteria are to have a history of knee surgery; patients with electrical implants such as a pace maker; to be pregnant. Before the treatment and after the last session of the treatment WOMAC and VAS questionnaires will be fulfilled to compare the results.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201210011292N3
Registration date:2012-10-08, 1391/07/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-10-08, 1391/07/17
Registrant information
Name
Vahideh Toopchizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 984113335625
Email address
toopchi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-04-05, 1391/01/17
Expected recruitment end date
2012-10-07, 1391/07/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Dexamethasone phonophoresis versus ultrasound therapy in knee Osteoarthritis
Public title
Comparison of Dexamethasone phonophoresis versus ultrasound therapy in knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having mild to moderate Osteoarthritis; being over 50 years old
Exclusion criteria: having a history of knee surgery; patients with electrical implants such as a pace maker; being pregnant; patients with lower limb thrombosis; patients with cancer
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
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 Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah Square
City
Tabriz
Postal code
Approval date
2012-04-04, 1391/01/16
Ethics committee reference number
9197
Health conditions studied
1
Description of health condition studied
Osteoarthritis of knee
ICD-10 code
M19.0
ICD-10 code description
Primary arthrosis of other joints
Primary outcomes
1
Description
Pain
Timepoint
Before and after the treatment
Method of measurement
VAS questionnaire
2
Description
Function
Timepoint
Before and after the treatment
Method of measurement
WOMAC questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Patients in phonophpresis group will be treated with Dexamethasone phonophoresis with 4 mg dexamethasone for 10 sessions, 3 sessions per week.
Category
Treatment - Drugs
2
Description
Patients in ultrasound group will be treated with ultrasound for 10 session, 3 session per week and each session for 10 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada hospital
Full name of responsible person
Vahideh Toopchizadeh
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostad Rahimi
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah Square
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Roja Javadi
Position
Physiatry resident
Other areas of specialty/work
Street address
Physioterapy ward, Shohada hospital, El Goli st.
City
Tabriz
Postal code
Phone
+98 41 1526 2250
Fax
Email
toopchi@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Vahideh Toopchizadeh
Position
Physiatrist-Associate professor
Other areas of specialty/work
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Golgasht ave.
City
Tabriz
Postal code
Phone
+98 41 1526 2250
Fax
Email
toopchi@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Hemmati
Position
General Physican
Other areas of specialty/work
Street address
Emam Reza hospital, Golgasht ave.
City
Postal code
Phone
Fax
Email
mehdi.hemmati@rocketmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)