The Effect of transcranial direct stimulationof different brain cortex areas plus the traditional physical therapy on pain intensity and clinical functional ability of subjects with knee osteoarthritis: “A randomised controlled trial”
the effect of transcranial direct current stimulation of different regions of the cerebral cortex with the traditional physiotherapy treatment on pain intensity and clinical functional ability of people with knee osteoarthritis
Design
A: PT with M1 a-tDCS
B: PT with S1 a-tDCS
C: PT with DLPFC1 a-tDCS
D: PT with Sham tDCS
Randomization: simple
sample size: cochran formula
Settings and conduct
This study is a double-blind, randomized controlled trial, that will be carried out at the Musculoskeletal Rehabilitation Center of Ahvaz Rehabilitation school. The assessor physiotherapist and participants will be blind . After initial evaluation, they will be treated ten sessions for two weeks
Participants/Inclusion and exclusion criteria
1- Individuals aged 50-70 years
2- Individuals with grades 2 and 3 of OA to the diagnosis of orthopedics by Kellgren and Lawrence system
3. Have at least 3 signs of the 6 clinical symptoms of American College of Rheumatology
4- People with dominant right leg involvement (in the case of bilateral, the right lesion is also dominant)
5- Minimal pain 4 according to the visual scale of pain
6. People with limited knee range
Intervention groups
A: PT with M1 a-tDCS
B: PT with S1 a-tDCS
C: PT with DLPFC a-tDCS
D: PT with Sham tDCS
Main outcome variables
Pain; function; range of motion; strength
General information
Reason for update
Acronym
tDCS
IRCT registration information
IRCT registration number:IRCT20181216042010N1
Registration date:2018-12-25, 1397/10/04
Registration timing:registered_while_recruiting
Last update:2018-12-25, 1397/10/04
Update count:0
Registration date
2018-12-25, 1397/10/04
Registrant information
Name
Fatemeh Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4331 4954
Email address
rahimi.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of transcranial direct stimulationof different brain cortex areas plus the traditional physical therapy on pain intensity and clinical functional ability of subjects with knee osteoarthritis: “A randomised controlled trial”
Public title
The Effect of transcranial direct stimulationof different brain cortex areas plus the traditional physical therapy on pain and function of subjects with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals aged 50-70 years
Individuals with grades 2 and 3 of OA to the diagnosis of orthopedics by System Kellgren and Lawrence
Having at least 3 signs of the 6 clinical symptoms of the American College of Rheumatology
People with dominant right leg involvement (in the case of bilateral, the right lesion is also dominant)
Minimal pain 4 according to the visual scale of pain
Exclusion criteria:
Having knee surgery for the last six months
Replacing the knee joint or tibia osteotomy on the affected side
Neurological conditions affecting organ function (Parkinson's disease, stroke and multiple sclerosis)
Inability to walk without help
History of another rheumatic disease that causes secondary osteoarthritis
People with lack of sensation and epilepsy whom pain modification techniques are prohibited
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is a simple randomization method that is performed using 4 sealed envelopes containing group names based on the type of intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
The assessor physiotherapist and participants are blind
Placebo
Used
Assignment
Parallel
Other design features
NO
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapour University of Medical Sciences
Street address
Golestan high way
City
Ahvaz
Province
Khouzestan
Postal code
61357- 15794
Approval date
2018-10-20, 1397/07/28
Ethics committee reference number
IR.AJUMS.REC.1397.519
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M17.1
ICD-10 code description
Unilateral primary osteoarthritis of knee
Primary outcomes
1
Description
pain
Timepoint
before initiation of treatment, 10 session, 1 month ago
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
function
Timepoint
before initiation of treatment, 10 session, 1 month ago
Method of measurement
questionnaire and tests
2
Description
strength of muscle
Timepoint
before initiation of treatment, 10 session, 1 month ago
Method of measurement
dynamometer
3
Description
range of motion
Timepoint
before initiation of treatment, 10 session, 1 month ago
Method of measurement
goniameter
Intervention groups
1
Description
Intervention group: traditional Physiotherapy(Ultrasound, Infra-Red, Trans- cutaneous Electrical Nerve Stimulation, Exercise therapy) with trans-cranial direct current stimulation of primary motor cortex for ten sessions
Category
Rehabilitation
2
Description
Intervention group: traditional Physiotherapy traditional Physiotherapy(Ultrasound, Infra-Red, Trans- cutaneous Electrical Nerve Stimulation, Exercise therapy) with transcranial direct current stimulation of primary sensory cortex for ten sessions
Category
Rehabilitation
3
Description
Intervention group: traditional Physiotherapy traditional Physiotherapy(Ultrasound, Infra-Red, Trans- cutaneous Electrical Nerve Stimulation, Exercise therapy) with transcranial direct current stimulation of dorsolateral perfrontal cortex for ten sessions
Category
Rehabilitation
4
Description
Control group: traditional Physiotherapy traditional Physiotherapy(Ultrasound, Infra-Red, Trans- cutaneous Electrical Nerve Stimulation, Exercise therapy) with sham transcranial direct current stimulation for ten sessions
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of rehabilitation school,Jundishapour university, Golestan Highway, Ahvaz
Full name of responsible person
Gholamhosein Nassaj
Street address
Clinic of rehabilitation school,Jundishapour university, Golestan Highway, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
33133- 611357
Phone
+98 61 3743 1013
Email
nassadj@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Golestan highway, Ahvaz,Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
itc@ajums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Gholmhosein Nassaj
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation school of Ahvaz Jundishapour university, Golestan highway, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
33133 -61357
Phone
+98 613337431011162
Email
nassadj@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Gholamhosein Nassaj
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation school of Jundishapour university, Golestan highway, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
33133 -61357
Phone
+98 613337431011162
Email
nassadj@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Rahimi
Position
Ph.D candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation school of Ahvaz Jundishapour university,Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
33133 -61357
Phone
+98 61 3337 4310
Email
Rahimi.f@ajums.ac.ir
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentified individuals
When the data will become available and for how long
6 months after publishing
To whom data/document is available
Data will only be available to researchers in academic and scientific institutes
Under which criteria data/document could be used
If someone want to do a similar research project
From where data/document is obtainable
Gholamhosein Nassaj
What processes are involved for a request to access data/document