The comparison of the effect of trans-cutaneous electrical nerve stimulation (TENS) upon sympathetic ganglion and acupuncture points on local circulation of lower extremity in healthy subjects
Objective:The comparison of the effect of trans-cutaneous electrical nerve stimulation (TENS) upon sympathetic ganglion and acupuncture points on local circulation of lower extremity in healthy subjects.
Design: This is a clinical trial. Sampling method is simple sampling. subjects will be randomly divide to three groups.
Setting and Conduct: The blood circulation in the thumb of the left foot will be recorded by laser Doppler flow-meter. Circulation at time zero will be recorded as baseline and then once every 3 minutes to 21 minutes will be measured and compared with the baseline blood flow.
Participants: 75 healthy volunteers (male and female) aged 18 to 25 years.
Intervention: Group1 will receive low frequency electrical stimulation in the thoracic-lumbar sympathetic ganglion (T12,L1,L2). Group2 will receive stimulation in acupuncture points (EX-LF10, SF36) and group3 will receive stimulation in the middle of leg. The electrical stimulation will apply to these areas for 21 minutes.
Outcome measures: The blood circulation in the thumb of the left foot.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016022126674N1
Registration date:2016-04-04, 1395/01/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-04, 1395/01/16
Registrant information
Name
Marzieh Mohamadi
Name of organization / entity
Shiraz University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 1551
Email address
mohamadm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shiraz University of Medical Sciences
Expected recruitment start date
2011-09-21, 1390/06/30
Expected recruitment end date
2012-04-19, 1391/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of trans-cutaneous electrical nerve stimulation (TENS) upon sympathetic ganglion and acupuncture points on local circulation of lower extremity in healthy subjects
Public title
The effect of electrical stimulation on the circulation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Healthy subjects
Age range of 18 to 25
Exclusion criteria:
Autonomic system disorders
cardiovascular disease
Reynold's disease
Cigaret abuse
Vasodilatory drug use
Age
From 18 years old to 25 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Blocked randomization method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthics Committee of Shiraz University of Medical Sciences
Street address
Zand Street
City
Shiraz
Postal code
Approval date
2011-08-03, 1390/05/12
Ethics committee reference number
CT-90-56-37
Health conditions studied
1
Description of health condition studied
Circulation disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
lower etremity circulation
Timepoint
Before intervention, Just after intervention, each 3 minutes till 21 minutes after intervention
Method of measurement
Laser Doppler flowmetry
Secondary outcomes
empty
Intervention groups
1
Description
Trans-cutaneous electrical nerve stimulation on thoracic-lumbar sympathetic ganglion
Category
Other
2
Description
Trans-cutaneous electrical nerve stimulation on acupuncture points
Category
Other
3
Description
Trans-cutaneous electrical nerve stimulation on middle of leg (control)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz university of Medical Sciences, School of Rehabilitation Sciences
Full name of responsible person
Saeed Heidari
Street address
Abiverdi1 Street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyed Basir Hashemi
Street address
Zand Street, Vice Chancellor for research of Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
CT-90-56-37
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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
Shiraz University of Medical Sciences, School of Rehabilitation Sciences
Full name of responsible person
Saeed Heidari
Position
Student
Other areas of specialty/work
Street address
Abiverdi1 Street
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
Email
saeedheidari298@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences, School of Rehabilitation Sciences
Full name of responsible person
Dr Fahimeh Kamali
Position
Associate Professor
Other areas of specialty/work
Street address
Abiverdi1 Street
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
Email
fahimehkamali@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences, School of Rehabilitation Sciences
Full name of responsible person
Marzieh Mohamadi
Position
Student
Other areas of specialty/work
Street address
Abiverdi1 Street
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
Email
mohamadipt@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)