Protocol summary

Summary
Objectives: This study has been designed to investigate the effect of kinesio-taping on pain reduction in young female with menstrual low back pain Design: Randomized control trial. Setting and conduct: 60 subjects will be allocated randomly in one of the control (n=30) or experimental group (n=30). Participants including major eligibility criteria: Young female students with menstrual low back pain. Exclusion Criteria includes reporting of any diseases that may induce low back pain Intervention: Using kinesio taping with H technique on the lumbar region. Main outcome measurements: Pain perception by visual analogue scale, type of pain and its severity by McGill questionnaire, level of disability due to pain by Oswestry Disability Index

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201312241254N9
Registration date: 2014-01-27, 1392/11/07
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-01-27, 1392/11/07
Registrant information
Name
Amir Hoshang Bakhtiary Davijani
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1444 1983
Email address
amirbakhtiary@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Semnan University of Medical Sciences
Expected recruitment start date
2014-05-04, 1393/02/14
Expected recruitment end date
2014-08-04, 1393/05/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Taping on low back pain during menstruation in female student
Public title
Effect of taping on low back pain during menstruation in female students of Semnan University of Medical Sciences
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Young female student with low back pain during menstruation Exclusion criteria: Diabetes; neuro-muscular diseases; musculoskeletal disease; cardiovascular disease; respiratory disease; systemic diseases; spondylolisthesis and spondylolysis; surgical history in lumbar region; history of trauma to vertebra column during last weak; disc herniation; sign of nerve root compression; polyneuropathy; carcinoma; vertebra tumor; pregnancy; history of lumbar exercise training during last three months.
Age
From 18 years old to 25 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Semnan University Medical Sciences
Street address
Vice chancellor for research, Headquartered of University, Basij Blv.
City
Semnan
Postal code
Approval date
2013-12-22, 1392/10/01
Ethics committee reference number
33214

Health conditions studied

1

Description of health condition studied
Menstrual back pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
before and after 5 days of taping
Method of measurement
visual analogue scale

2

Description
Severity of pain
Timepoint
Before and after 5 days of taping
Method of measurement
McGill Pain questionnaire

Secondary outcomes

1

Description
Disability
Timepoint
Before and after 5 days of taping
Method of measurement
Oswestry disability index

Intervention groups

1

Description
Intervention: During menstruation, kinesio taping will be attached over the para spinal muscles of lumbar vertebral column using H technique. Two longitudinal band of kinesio tape will be attached over the left and right para vertebral muscles of vertebral column and a transverse band will be attached over the right and left L5 and S1 vertebra during.
Category
Rehabilitation

2

Description
Control group: During menstruation, no kinesio taping will be used.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Semnan University of Medical Sciences girls dorm
Full name of responsible person
Fatemeh Sheykhian
Street address
Semnan University of Medical Sciences, km 5 road to Damghan,
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Semnan University of Medical Sciences
Full name of responsible person
Dr Raheb Ghorbani,
Street address
No 443, Headquartered University, Basij Bolv.
City
Semnan
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 of 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, Semnan University of Medical Sciences
Full name of responsible person
Amir Hoshang Bakhtiary
Position
Professor/ PhD
Other areas of specialty/work
Street address
N0 229, Ghods Ave
City
Semnan
Postal code
Phone
+98 231332850
Fax
Email
amirbakhtiary@sem-ums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Neuromuscular Rehabilitation Research center, Semnan University of Medical Sciences
Full name of responsible person
Amir Hoshang Bakhtiary
Position
Professor/ PhD
Other areas of specialty/work
Street address
NO 229, Ghods Blv
City
Semnan
Postal code
Phone
+98 23 1332 8502
Fax
Email
amirbakhtiary@sem-ums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences
Full name of responsible person
Amir Hoshang Bakhtiary
Position
Professor/ PhD
Other areas of specialty/work
Street address
NO 229, Ghods Ave
City
Semnan
Postal code
Phone
+98 23 1332 8502
Fax
Email
amirbakhtiary@sem-ums.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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