Comparing the effect of Kinesio Taping (KT) and Placebo Taping (P) on Lateral Abdominal Wall and Lumbar Multifidus Muscles Thickness Change in Subjects With Non-Specific Chronic Low Back Pain
Effect of Kinesio Taping on Thickness Changes of Lateral Abdominal and Multifidus Muscles in Non-Specific Chronic Low Back Pain
Design
Randomized control trial, with two parallel groups and double blinded
Settings and conduct
This research is a double-blind, control clinical trial. This research is carried out at the Tehran University of Medical Sciences Rehabilitation Faculty Research Center. In this research, a pilot and reliability study will be conducted than main research will be done. Subjects enter the research after completing the consent form, understanding of how to do the research and having the inclusion criteria . Individual information is collected by questionnaire. After the randomization, the subject is placed in one of the intervention or control groups. Ultrasound findings from abdominal and lumbar muscles are collected before intervention. For the intervention group, the kinesio taping of the lumbar and abdominal muscles are used, and the placebo taping is used for the control group. After 72 hours, reassessment takes place. In this study, participants, data collectors and data analyzers are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Subjects aged 25 - 55 years with history of low back pain Lasting more than 3
Pain intensity between 4-7 of the Visual Analog Scale (VAS)
Exclusion criteria:
Allergic sign of kinesio taping
Taking painkiller during research
Intervention groups
In the intervention group, kinesio taping of the lumbar and abdominal muscles is performed and placebo taping is used for the control group.
Main outcome variables
Pain intensity; Disability level; Muscle Thickness change (transvers abdominis (TrA), internal oblique (IO), external oblique (EO) and multifidus (MF) ) in both sides, left and right
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090301001722N20
Registration date:2018-05-21, 1397/02/31
Registration timing:registered_while_recruiting
Last update:2018-05-21, 1397/02/31
Update count:1
Registration date
2018-05-21, 1397/02/31
Registrant information
Name
Samira Karimpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
hadianrs@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-05-24, 1397/03/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Kinesio Taping (KT) and Placebo Taping (P) on Lateral Abdominal Wall and Lumbar Multifidus Muscles Thickness Change in Subjects With Non-Specific Chronic Low Back Pain
Public title
Effect of Kinesio Taping (KT) on Abdominal and Lumbar Muscles Thickness Change in Chronic Low Back Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Lasting more than 3 months and radiating no further than the buttock
Pain intensity between 4-7 of the Visual Analog Scale (VAS)
No open wounds and skin diseases
No previous history of neurological disease
No previous history of sciatica or other radicular involvement
No previous history of disc herniation
No previous history of spine surgery
No previous history of rheumatic diseases and diabetes
No previous history of mental disease
No pregnancy
No previous history of neuromascular diseases
Exclusion criteria:
Allergic sign of kinesio taping
Taking painkiller during research
Age
From 25 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is used in the form of a random number table. Participants will be randomly assigned to their treatment groups
according to the numbers obtained from the table, KT group (pair numbers) and placebo (odd numbers). The allocation of the subjects will be concealed by using sequentially numbered, sealed and opaque envelopes. On the first day of treatment, the envelope allocated will be opened by participant.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will be blinded to the study hypotheses (ie, KT versus Placebo). Due to the nature of the interventions it was not be possible to blind the researcher. A blinded assessor will be assessed clinical outcomes. Data analyst is also blind as statistics consultant.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Keshavarz bolvar, Ghods Ave, 6 floor, Tehran University of Medical Science building
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-05-29, 1396/03/08
Ethics committee reference number
IR.TUMS.FNM.REC.1396.2448
Health conditions studied
1
Description of health condition studied
Non Specific Chronic Low Back Pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain intensity
Timepoint
Before and 72 hours after intervention
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Disability index
Timepoint
Before and 72 hours after intervention
Method of measurement
Oswestry Questionnaire
3
Description
Muscle thickness change
Timepoint
Before and 72 hours after intervention
Method of measurement
In formula
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Kinesio taping of the lumbar and abdominal muscles is performed
Category
Treatment - Other
2
Description
Control group: Placebo taping is used for the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation cilinic of Tehran University of Medical Science
Full name of responsible person
Dr Mohsen Mir
Street address
Engheleb Ave
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 5132
Email
abbasipt85@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Ali Sohrabpour
Street address
Keshavarz Blvd, Tehran University of Medical Science
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8893 3767
Email
aasohrabpour@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Hadian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Engheleb Ave, Rehabilitation School
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 6586
Email
hadianrs@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammah Reza Hadian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Engheleb Ave, Rehabilitation School
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 6586
Email
hadianrs@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soheila Abbasi
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Engheleb Ave, Rehabilitation School
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 5132
Email
abbasipt85@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
All rights of this research belongs to TUMS.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available