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The effect of transcranial direct current stimulation(TDCS) with postural training on balance, static and dynamic standing postural stability in the patients with chronic low back pain(CLBP)

Protocol summary

Summary
The aim of present study was to evaluate the effect of transcranial direct current stimulation (TDCS) with postural training on balance, static and dynamic standing postural stability in the patients with chronic low back pain (CLBP). This study is a clinical trial design. Participants randomly will be divided into three groups. People of the first group to received TDCS over the primary motor cortex area with postural training in twenty minutes during two weeks; people of second group to received postural training with TDCS in the form of placebo in twenty minutes per session during two weeks (set up TDCS device electrodes on primary motor cortex area and contralateral supraorbital area and then electrical stimulation was turned off after thirty seconds) and people of third group to received just postural training without electrical stimulation. Stabilization exercise will be performed on Byodex Balance System (BBS) in each session about 20 minutes for 3 sessions per week during 2 weeks. Volunteer patients with chronic low back pain (CLBP) who are between ages of 18 to 40 years and they have chronic back pain for at least 3 months (12 weeks) by medical diagnosis and physiotherapy, and as well as peoples who will be entered into study to signed the informed consent form. The exclusion criteria are include the patients with other chronic pain syndromes, spinal cord surgery in the last 6 months, neurological diseases, rheumatology and psychiatric diseases, pregnancy or getting pregnant during the study, use of pacemakers or any other instrument in the body, previous treatments with transcranial direct current stimulation (TDCS), specific pathologies in the spinal cord (fracture, neoplasm, deformity, Schuermann's disease, infection, radiculopathy, vertebral fractures or spondylolisthesis), use of medication and drug or alcohol abuse, participation in athletic activities and not athlete, vestibular disorders, use of drugs that affecting on balance and history of migraine. All participants will be requested to stand on each static and dynamic surfaces of Byodex Balance System for 30 seconds in before and after transcranial direct current stimulation. Accordingly, the anterior/posterior, medial/lateral and overall stability indexes will be measured in before and after TDCS. Also the individuals balance level after intervention will be measured with the Berg Balance Scale. On the other hand, people of study will be re-evaluated after one month. The participants of each group and assessors to blinded the experimental conditions and interventions in each group and the study is double blind side.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017070934969N1
Registration date: 2017-08-30, 1396/06/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-08-30, 1396/06/08
Registrant information
Name
abbas jafarzadeh
Name of organization / entity
Neuromuscular Rehabilitation Research Center
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
a.jafarzadeh93@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology of Semnan University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of transcranial direct current stimulation(TDCS) with postural training on balance, static and dynamic standing postural stability in the patients with chronic low back pain(CLBP)
Public title
The effect of transcranial direct current stimulation(TDCS) with postural training on balance, static and dynamic standing postural stability in the patients with chronic low back pain(CLBP)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Volunteer patients with chronic low back pain (CLBP) who are between ages of 18 to 40 years and they have chronic back pain for at least 3 months (12 weeks) by medical diagnosis and physiotherapy, and as well as peoples who will be entered into study to signed the informed consent form. The exclusion criteria are include the patients with other chronic pain syndromes, spinal cord surgery in the last 6 months, neurological diseases, rheumatology and psychiatric diseases, pregnancy or getting pregnant during the study, use of pacemakers or any other instrument in the body, previous treatments with transcranial direct current stimulation (TDCS), specific pathologies in the spinal cord (fracture, neoplasm, deformity, Schuermann's disease, infection, radiculopathy, vertebral fractures or spondylolisthesis), use of medication and drug or alcohol abuse, participation in athletic activities and not athlete, vestibular disorders, use of drugs that affecting on balance and history of migraine
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan university of medical science
Street address
Semnan، University of Medical Sciences Semnan، 5 km road Damghan ،Faculty of Rehabilitation
City
semnan
Postal code
Approval date
2017-07-16, 1396/04/25
Ethics committee reference number
IR.SEMUMS.REC.1396.61

Health conditions studied

1

Description of health condition studied
Low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain

Primary outcomes

1

Description
Static and dynamic stability indices
Timepoint
Before and after receiving after intervention
Method of measurement
Byodex Balance System

Secondary outcomes

1

Description
balance
Timepoint
Before and after receiving intervention
Method of measurement
Berg balance scale

Intervention groups

1

Description
Intervention group: All participants will be requested to stand on each static and dynamic surfaces of Byodex Balance System for 30 seconds in before and after transcranial direct current stimulation. In the intervention of TDCS, the anode and cathode electrodes respectively will be placed on primary motor cortex and contralateral supraorbital area and the stimulation will be applied with 2 milliamps intensity for 20 minutes. The postural training with TDCS intervention will be performed for 3 sessions per week for 2 weeks.
Category
Rehabilitation

2

Description
Control group: All participants will be requested to stand on static and dynamic surfaces of Byodex Balance System for 30-second in before and after postural training with sham-TDCS intervention. In sham-TDCS intervention, anode and cathode electrodes respectively will be placed on primary motor cortex and contralateral supraorbital area. Stimulations will be applied with 2 milliamps intensity for 30 seconds. Postural training with sham-TDCS intervention will be performed for 3 sessions per week for 2 weeks.
Category
Rehabilitation

3

Description
Control group: All participants will be requested to stand on static and dynamic surfaces of Byodex Balance System for 30-second in before and after just postural training. Postural training alone will be performed for 3 sessions per week for 2 weeks.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation research Center
Full name of responsible person
fatemeh ehsani
Street address
Ghods Blvd, Semnan
City
semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research and Technology, Semnan University of Medical Sciences
Full name of responsible person
dr.ali rashidipour
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology, Semnan 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
Neuromuscular Rehabilitation Research Center
Full name of responsible person
fatemeh ehsani
Position
Assisstant Professor
Other areas of specialty/work
Street address
Blvd Ghods, Semnan
City
semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
fatemehehsani59@yahoo.com; jafarzadehabbas8005@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Neuromuscular Rehabilitation Research Center
Full name of responsible person
fatemeh ehsani
Position
Assistant Professor
Other areas of specialty/work
Street address
Blvd Ghods, Semnan
City
semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
fatemehehsani59@yahoo.com; jafarzadehabbas8005@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Neuromuscular Rehabilitation Research Center
Full name of responsible person
abbas jafarzadeh
Position
student
Other areas of specialty/work
Street address
Blvd Ghods, Semnan
City
semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
a.jafarzadeh93@semums.ac.ir; f.ehsani@semums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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