Protocol summary
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Study aim
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Comparative effect of anodal and cathodal direct cerebral electrical stimulation on postural control in chronic low back pain patients with high pain-related anxiety
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Design
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Clinical trial with parallel control group, double blind, randomized, Control with placebo, single center trial, Sample size 66 people.
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Settings and conduct
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Neuromuscular Rehabilitation Research Center, Semnan.
Study participants and evaluators are unaware of the allocation of study groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:20-45years old,right-handed,anxiety score due to pain more than30,suffering chronic low back pain; pain score less than3out of10on a visual analog scale.
Exclusion criteria:neurological and cerebellar diseases, psychological illnesses;structural deformities in the spine and lower extremities,abnormalities in the vestibular system .
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Intervention groups
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Intervention group1: According to the treatment protocol, Anodal trans-cranial direct current stimulation (a-tDCS) is applied to the affected motor cortex 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 is performed for patients.
Control group: Based on the treatment protocol, placebo stimulation is applied for patients.
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Main outcome variables
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-Postural stability in one static and two dynamic conditions in level 7 and 4. (with both feet under open and closed eyes conditions during a 30 seconds trial, before,immediately, 48 hours and one-week after tDCS intervention).
-Error rate(number of errors/number of auditory signals (during 30 seconds test-7 trial)) and reaction time during the auditory stroop task in dual take test.
General information
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Reason for update
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Defective information in the design variables section.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20151228025732N46
Registration date:
2019-11-27, 1398/09/06
Registration timing:
registered_while_recruiting
Last update:
2021-02-12, 1399/11/24
Update count:
1
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Registration date
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2019-11-27, 1398/09/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-06-16, 1398/03/26
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Expected recruitment end date
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2020-03-19, 1398/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparative effect of anodal and cathodal direct cerebral electrical stimulation on postural control in chronic low back pain patients with high pain-related anxiety
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Public title
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Comparative effect of anodal and cathodal direct cerebral electrical stimulation on postural control in chronic low back pain patients with high pain-related anxiety
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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Inclusion criteria:
20-45 years old;
Right-handed patients;
Having pain-related anxiety score more than 30, based on Pain Anxiety Symptoms Scale (PASS)
Suffering from chronic LBP (for more than six weeks or recurrent LBP with at least three episodes lasted more than one week over the past 12 months)
A pain score less than 3 out of 10 on a visual analog scale (VAS) on the testing day
Exclusion criteria:
Any history of neurological diseases, such as Parkinson’s Disease, Alzheimer
Reporting any history of psychological illnesses
Presence of any signs of radiculopathy or root lumbar spinal cord involvement
Structural deformities in the spine or the lower extremities such as scoliosis, kyphosis, or lordosis
Any abnormalities in the vestibular system
Cerebellar disorders
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Age
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From 20 years old to 45 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
66
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Study participants and evaluators are unaware of the allocation of study groups.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-06-16, 1398/03/26
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Ethics committee reference number
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IR.NIMAD.REC.1398.251
Health conditions studied
1
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Description of health condition studied
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Chronic low back pain
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ICD-10 code
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M54.5
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ICD-10 code description
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Low back pain
Primary outcomes
1
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Description
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Static and dynamic balance evaluation ( in static and 4,7 level of dynamic condition; with both feet under open and closed eyes conditions during a 30 seconds trial)
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Timepoint
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Before and immediately ,48 hours and one week after intervention
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Method of measurement
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Biodex Balance System (BBS) (302-950 model, Biodex Medical Systems, Inc. 20, New York, USA)
Secondary outcomes
1
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Description
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Error rate (number of errors/number of auditory signals(during 30 seconds test-7 trial)) during the auditory stroop task in dual take test
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Timepoint
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Before and immediately ,48 hours and one week after intervention
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Method of measurement
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Auditory stroop task (AST) written by a programmer and implemented by Matlab (R2018A, Mathworks, Navick, MA, USA) software
2
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Description
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Reaction time during the auditory stroop task in dual take test (the interval between the two consecutive stimuli will be randomized (2,000 ms to 3,000 ms). All reactions with response delays longer than 3,500 ms will be discarded)
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Timepoint
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Before and immediately ,48 hours and one week after intervention
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Method of measurement
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Auditory stroop task (AST) written by a programmer and implemented by Matlab (R2018A, Mathworks, Navick, MA, USA) software
Intervention groups
1
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Description
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Intervention group1: According to the treatment protocol, Anodal trans-cranial direct current stimulation (a-tDCS) is applied to the affected motor cortex is performed for patients.
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Category
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Rehabilitation
2
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Description
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Intervention group 2: According to the treatment protocol, Cathodal trans-cranial direct current stimulation (c-tDCS) is applied to the affected motor cortex is performed for patients.
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Category
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Rehabilitation
3
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Description
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Control group: Based on the treatment protocol, placebo stimulation is applied for patients.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Semnan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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When the data will become available and for how long
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To whom data/document is available
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Only available to scholars working in academic institutions.
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Under which criteria data/document could be used
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In case of relevant studies.
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From where data/document is obtainable
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Fatemeh Ehsani. Neuromuscular Rehabilitation Research Center, Ghods Blvd. +98 9191310755
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What processes are involved for a request to access data/document
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Comments
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