comparison the effects of high-frequency, low frequency and placebo transcutaneous electrical nerve stimulation (TENS) on the brain electrical activities following induced pain in healthy subjects
The purpose of this study is to compare the effects of transcutaneous electrical nerve stimulation (TENS) with high-frequency, low frequency and placebo on the brain electrical activities following induced pain in healthy subjects.
In the present study, 30 right handed healthy subjects (10 subjects in each group) aged 25-18 years are selected through convenience sampling and then are assigned to three TENS groups (high frequency, low frequency, placebo) randomly. First, the brain waves are recorded for 2 minutes (1 minute with open eyes, 1 minute with close eyes).Then, by Submaximal Effort Tourniquet Technique ischemic pain is induced in the left forearm and hand and the subject records pain intensity by Visual Analog Scale (VAS), brain waves are recorded for 2 minutes and one type of TENS is applied for 20 minutes .After that, TENS is turned off and VAS and brain waves are recorded immediately, 15 and 30 minutes after the TENS. Finally, the effect of three types of mentioned TENS on the power of brain waves will be compared
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201501191552N3
Registration date:2015-02-18, 1393/11/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-02-18, 1393/11/29
Registrant information
Name
Maryam Ebrahimian
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1551
Email address
ebrahimian@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research of Shiraz University of Medical Sciences
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison the effects of high-frequency, low frequency and placebo transcutaneous electrical nerve stimulation (TENS) on the brain electrical activities following induced pain in healthy subjects
Public title
Comparison of the Effects of Three Types of Electrical Stimulation on Brain Activity Following Induced Pain in Healthy Subjects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Right-handed healthy subjects between the ages of 18-25
Exclusion criteria: Presence of any pain; cardiovascular diseases; neuromuscular diseases; use of antidepressants and antihistamines drugs and alcohol; deformity of the upper limb (especially the hand )
Age
From 75 years old to 68 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
in front of Felestin St., Zand Ave.
City
Shiraz
Postal code
1433671348
Approval date
2014-12-30, 1393/10/09
Ethics committee reference number
CT- 9372-7272
Health conditions studied
1
Description of health condition studied
Acute pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
Power of brain waves
Timepoint
Before,immediately after, 15 and 30 minutes after intervetion
Method of measurement
Electroencephologrphy
2
Description
Pain intensity
Timepoint
Immediately after, 15 and 30 minutes after intervetion
Method of measurement
Visual Analog Scale(VAS)
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group No.1, the high frequncy TENS(80 HZ) with 150 microscond duration for 20 minutes will be used.
Category
Treatment - Other
2
Description
In the intervention group No.2, the low frequency TENS(3 HZ) with 250 microscond duration for 20 minutes will be used.
Category
Treatment - Other
3
Description
In the control group, the placebo(sham) TENS for 20 minutes will be used.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation Sciences School of Shiraz University of Medical Sciences
Full name of responsible person
Maryam Ebrahimian
Street address
Abiverdi No.1 St., Shahid Chamran Blvd.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Affirs of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Sayed Basir Hashemi
Street address
7th fioor of Central Building of Shiraz University of Medical Sciences, In front of Felestin Street, Zand Avenue.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research Affirs of Shiraz 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
Rehabilitation Sciences School of Shiraz University of Medical Sciences