Comparative effect of anodal and cathodal direct cerebral electrical stimulation on postural control in patients with chronic low back pain
Design
Clinical trial with parallel control group, double blind, randomized, Control with placebo, single center trial, Sample size 66 people.
Settings and conduct
Neuromuscular Rehabilitation Research Center, Semnan.
Study participants and evaluators are unaware of the allocation of study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged 20-45 years; Right-handed patients; Anxiety score due to pain More than 30.
Exclusion criteria: Neurological diseases, Parkinson, Alzheimer; History of mental illness.
Intervention groups
Intervention group1: According to the treatment protocol, Anodal trans-cranial direct current stimulation (a-tDCS) is applied to the affected motor cortex and routine physiotherapy is performed for patients.
Intervention group2: According to the treatment protocol, Cathodal trans-cranial direct current stimulation (c-tDCS) is applied to the affected motor cortex and routine physiotherapy is performed for patients.
Control group: Based on the treatment protocol, placebo stimulation and routine physiotherapy is applied for patients.
Main outcome variables
Static and dynamic balance evaluation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N46
Registration date:2019-11-27, 1398/09/06
Registration timing:registered_while_recruiting
Last update:2019-11-27, 1398/09/06
Update count:1
Registration date
2019-11-27, 1398/09/06
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-16, 1398/03/26
Expected recruitment end date
2020-03-15, 1398/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of anodal and cathodal direct cerebral electrical stimulation on postural control in patients with chronic low back pain
Public title
Comparative effect of anodal and cathodal direct cerebral electrical stimulation on postural control in patients with chronic low back pain
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
20-45 years old;
Right-handed patients;
Anxiety score due to pain More than 30.
Exclusion criteria:
Neurological diseases: Parkinson, Alzheimer
History of mental illness
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are allocated randomly with simple sequential allocation in one of the two study groups by help of sealed envelope and receive the intervention of the same group. The unit of randomization is patient. Sealed envelopes are delivered to expert. With each patient's visit, one of the envelopes is randomly selected by the patients and determines the study group. The stratification approach is not used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Study participants and evaluators are unaware of the allocation of study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee National Institute for Medical Research Development
Street address
No. 2, Besat Street, West Fatemi Street, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Approval date
2019-06-16, 1398/03/26
Ethics committee reference number
IR.NIMAD.REC.1398.251
Health conditions studied
1
Description of health condition studied
Chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Static and dynamic balance evaluation
Timepoint
Before and after intervention
Method of measurement
Biodex Balance System & Biodex Medical Systems
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: According to the treatment protocol, Anodal trans-cranial direct current stimulation (a-tDCS) is applied to the affected motor cortex and routine physiotherapy is performed for patients.
Category
Rehabilitation
2
Description
Intervention group2: According to the treatment protocol, Cathodal trans-cranial direct current stimulation (c-tDCS) is applied to the affected motor cortex and routine physiotherapy is performed for patients.
Category
Rehabilitation
3
Description
Control group: Based on the treatment protocol, placebo stimulation and routine physiotherapy is applied for patients.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Fatemeh Ehsani
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
fatemehehsani59@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
P_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
fatemehehsani59@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Position
Semnan
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
fatemehehsani59@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mona Masoudi
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
are20935@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
-
When the data will become available and for how long
-
To whom data/document is available
Only available to scholars working in academic institutions.
Under which criteria data/document could be used
In case of relevant studies.
From where data/document is obtainable
Fatemeh Ehsani. Neuromuscular Rehabilitation Research Center, Ghods Blvd. +98 9191310755
What processes are involved for a request to access data/document