Protocol summary

Summary
Shortness of hamstring muscle is a common disorder in many societies. Side effect of this disorder, indicate necessity of treatment. During treatment of this disorder, pain of muscle is an obstacle. In order to reduce the pain of the muscle, we decided to use two types of electrical stimulation: a high and low frequency, which are produced by trans-cutaneous electrical nerve stimulation (TENS) machine. First of all, we choose patients with this disorder, then categorized them into four groups: 1.high frequency TENS 2.low frequency TENS 3.palcebo and 4.control. We used TENS for 30 minutes, four times. We measured parameters, once before stimulation, once exactly after stimulation, then ten minutes and eventually 30 minutes after stimulation. We expected three parameters to change: 1) intensity of pain 2) threshold of pain 3) range of motion. Intensity of pain was measured by VAS method. Threshold of pain and range of motion were measured by goniometer.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201011115152N1
Registration date: 2010-11-22, 1389/09/01
Registration timing: prospective

Last update:
Update count: 0
Registration date
2010-11-22, 1389/09/01
Registrant information
Name
HamidReza Bokaiyan
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1333 2329
Email address
boka@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Student Research Center, Semnan University of Medical Sciences
Expected recruitment start date
2010-12-11, 1389/09/20
Expected recruitment end date
2011-03-11, 1389/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of high and low Transcotaneous Electrical Nerve Stimulation on the muscle pain during hamstring passive stretching
Public title
Investigation of the effects of high and low Transcotaneous Electrical Nerve Stimulation on the muscle pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having a short hamstring muscle, minimum amount of 10 degrees lower than the normal 80 degrees flexion of the thigh. Exclusion criteria: any damage to the knee and hip or neuromuscular damage in lower limb or lumbar muscle tightness
Age
From 18 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
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 Sciences
Street address
Damghan Road, 5 km towards Damghan
City
Semnan
Postal code
Approval date
2010-07-21, 1389/04/30
Ethics committee reference number
2324.پ

Health conditions studied

1

Description of health condition studied
Contracture of muscle
ICD-10 code
m62.4
ICD-10 code description
Contracture of muscle

Primary outcomes

1

Description
Muscle tension pain
Timepoint
Before the intervention, immediately after the intervention, 10 minutes after the study, 30 minutes after intervention
Method of measurement
VAS test

Secondary outcomes

1

Description
Pain threshold
Timepoint
Before the intervention, immediately after the intervention, 10 minutes after the study, 30 minutes after intervention
Method of measurement
By measuring the first angle where the pain is felt

2

Description
muscle tightness
Timepoint
Before the intervention, immediately after the intervention, 10 minutes after the study, 30 minutes after intervention
Method of measurement
Using a measure based on muscle stretching technique (SLR)Straight leg raise

Intervention groups

1

Description
4) Without any intervention (do not have other routine treatments in the study)
Category
Treatment - Other

2

Description
3) To pretend to use the TENS machine (While the machine is off) and delivered in a 30 minutes time period
Category
Treatment - Other

3

Description
1) Low Frequency TENS frequency Hz5; pulse sμ 300; intensity equivalent to the threshold of stimulation at the secondary movement; and delivered in a 30 minutes time period
Category
Treatment - Other

4

Description
2) High frequency TENS frequency Hz5; pulse 50 sμ; intensity equivalent to the threshold of stimulation at the secondary movement; and delivered in a 30 minutes time period
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabatabaee Rehabilitation clinic
Full name of responsible person
AH Bakhtiari - Associate Professor School of Rehabilitation Sciences Semnan
Street address
Mashahir Boulevard, Opposite to the red crescent building
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr parviz kokhaee
Street address
Damghan Road, 5 km towards Damghan
City
Semnan
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
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 Faculty, Semnan University of Medical Sciences
Full name of responsible person
Amir Hooshang Bakhtiary
Position
Associate Professor
Other areas of specialty/work
Street address
Damghan Road, 5 km towards Damghan
City
Semnan
Postal code
Phone
+98 23 1335 4170
Fax
Email
amir822@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hamid Reza Bokaian
Position
Student
Other areas of specialty/work
Street address
Damghan Road, 5 km towards Damghan
City
Semnan
Postal code
Phone
+98 23 1333 3229
Fax
Email
hamid_boka67@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Ardestani
Position
student
Other areas of specialty/work
Street address
Damghan Road, 5 km towards Damghan
City
Semnan
Postal code
Phone
Fax
Email
ghasem.ardestani@yahoo.com
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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