Aim is comparison of tDCS and Sham tDCS for reduction of pain in patients with knee osteoarthritis attending to Imam-Reza Hospital in 2018
Design
Clinical trial with a control group with parallel groups, non blind, randomized.
Settings and conduct
This study was conducted as a clinical trial in Imam Reza Hospital and in patients with knee osteoarthritis, this is a non blind study in which patients will blinded. This is in phase 4 and in this 54 patients with a block method are divided into two groups, 27 patients in first intervention group and receive tDCS, and 27 patients in second intervention group receiving Sham tDCS. Based on this, at first and three month after starting treatment, pain of patients will assessed.
Participants/Inclusion and exclusion criteria
Patients with knee osteoarthritis, age between 20 to 70 years, pain over 6 months, VAS between 3 and 7 and Being able to express the intensity of pain will included in study, also patents with a metal or device in the head, carbamazepine use in the last 6 months, drug addiction, alcohol consumption in the last 6 months, history of neurological diseases, history of neurosurgery and a history of severe depression will excluded from study.
Intervention groups
In first group, stimulation will performed using transcranial direct current stimulation (tDCS) for 5 sessions and for 5 consecutive days using a 35 cm 2 electrode with a current of 2 mA, each stimulation was performed for 20 minutes, and in another stimulation will performed using Sham transcranial direct current stimulation (tDCS) for 5 sessions and for 5 consecutive days using a 35 cm 2 electrode with a current of 2 mA, each stimulation was performed for 30 seconds.
Main outcome variables
Pain of Knee Osteoarthritis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191214045724N1
Registration date:2020-02-02, 1398/11/13
Registration timing:registered_while_recruiting
Last update:2020-02-02, 1398/11/13
Update count:1
Registration date
2020-02-02, 1398/11/13
Registrant information
Name
Bahar Mohebi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 6637 3737
Email address
behar.moheb@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-20, 1398/10/30
Expected recruitment end date
2020-08-21, 1399/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of tDCS and Sham tDCS for reduction of pain in patients with knee osteoarthritis attending to Imam-Reza Hospital in 2018
Public title
Comparison of two methods in pain relief of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 to 70 years
Pain over 6 months
VAS between 3 and 7
Being able to express the intensity of pain
Exclusion criteria:
A metal or device in the head
Carbamazepine use in the last 6 months
Drug addiction
Alcohol consumption in the last 6 months
History of neurological diseases
History of Neurosurgery
A history of severe depression
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization is done with sealed envelope tools in such a way that the letters A and B are inserted in the envelopes and patients are asked to select an envelope that the intervention group A and the group B they will be tested.
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 Medical University for the Islamic Republic of Iran's Army
Street address
Tehran, West Fatemi St., Etemadzadeh Avenue, Medical University for the Islamic Republic of Iran's Army
City
Arak
Province
Markazi
Postal code
1411718541
Approval date
2020-01-26, 1398/11/06
Ethics committee reference number
IR.AJAUMS.REC.1398.233
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Pain of Knee Osteoarthritis
Timepoint
Instantly and 3 months after treatment
Method of measurement
Based on Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, stimulation was performed using transcranial direct current stimulation (tDCS) for 5 sessions and for 5 consecutive days using a 35 cm 2 electrode with a current of 2 mA, each stimulation was performed for 20 minutes.
Category
Rehabilitation
2
Description
Intervention group: In this group, stimulation was performed using Sham transcranial direct current stimulation (tDCS) for 5 sessions and for 5 consecutive days using a 35 cm 2 electrode with a current of 2 mA, each stimulation was performed for 30 seconds.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Bahare Mohebi
Street address
1411718541, Medical University for the Islamic Republic of Iran's Army, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
behar.moheb@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mostafa Shahrezaee
Street address
1411718541, Medical University for the Islamic Republic of Iran's Army, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
moshahrezayee@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Bahare Mohebi
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
1411718541, Medical University for the Islamic Republic of Iran's Army, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
behar.moheb@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Bahare Mohebi
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
1411718541, Medical University for the Islamic Republic of Iran's Army, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
behar.moheb@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Bahare Mohebi
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
1411718541, Medical University for the Islamic Republic of Iran's Army, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
behar.moheb@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available