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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

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History
# Registration date Revision Id
2 2020-05-08, 1399/02/19 134582
1 2018-05-21, 1397/02/31 46355
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  • General information

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    2017-09-23, 1396/07/01
    2018-06-05, 1397/03/15
    2018-05-24, 1397/03/03
    2018-12-06, 1397/09/15
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    2018-07-06, 1397/04/15
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    2018-12-21, 1397/09/30
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    2018-12-21, 1397/09/30
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    Change the number of groups, outcome measures and end of the study
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    تغییر تعداد گروه ها، متغییرها و پایان مطالعه
    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.
    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 (00-30), placebo (30-60) and control group or without tape (60-90). 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.
    جهت انجام توالی تصادفی از روش تصادفی سازی ساده از نوع جدول اعداد تصادفی استفاده می‌شود که در آن نمونه‌ها بر اساس اعداد بدست آمده از جدول به دو گروه آزمون (اعداد زوج) و پلاسبو (اعداد فرد) تقسیم می‌شوند و جهت پنهان سازی تخصیص تصادفی (allocation concealment) با استفاده از پاکت نامه‌های غیرشفاف مهروموم شده (numbered, sealed, opaque envelopes Sequentially) که از قبل به تعداد حجم نمونه مطالعه تهیه می‎شود و با حفظ توالی تصادفی، اعداد بدست آمده بسته بندی می‌شوند و در جلسه‌ای که فرد جهت جمع آوری داده‌ها وارد مطالعه می‌شود یکی را برداشته و با بازکردن آن گروهش مشخص می‌شود..
    جهت انجام توالی تصادفی از روش تصادفی سازی ساده از نوع جدول اعداد تصادفی استفاده می‌شود که در آن نمونه‌ها بر اساس اعداد بدست آمده از جدول به سه گروه آزمون (اعداد از 00-30)، پلاسبو (اعداد از 30-60) و گروه کنترل یا بدون تیپ (اعداد از 60-90) تقسیم می‌شوند و جهت پنهان سازی تخصیص تصادفی (allocation concealment) با استفاده از پاکت نامه‌های غیرشفاف مهروموم شده (numbered, sealed, opaque envelopes Sequentially) که از قبل به تعداد حجم نمونه مطالعه تهیه می‎شود و با حفظ توالی تصادفی، اعداد بدست آمده بسته بندی می‌شوند و در جلسه‌ای که فرد جهت جمع آوری داده‌ها وارد مطالعه می‌شود یکی را برداشته و با بازکردن آن گروهش مشخص می‌شود.
    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.
    Participants will be blinded to the study hypotheses (ie, KT versus Placebo or control). Due to the nature of the interventions it was not be possible to blind the researcher. So, the first researcher will apply the typing method, while the second researcher will be blind as the data evaluator. Data analyzer is also blind who is first researcher.
    در این پژوهش افراد شرکت کننده در مورد نوع گروه خوداطلاعی ندارند همچنین یک نفر به عنوان محقق و مراقب بالینی خواهد بود که روش تیپینگ را اعمال خواهد کرد که نمی تواند از نوع گروه ها اطلاعی نداشته باشد در حالی که نفر سوم به عنوان ارزیابی کننده داده ها کور می باشد. آنالیز کننده داده به عنوان مشاور آمار نیز کور می باشد.
    در این پژوهش افراد شرکت کننده در مورد نوع گروه خوداطلاعی ندارند. بعلت ماهیت تیپینگ نمیتوان محقق اعمال کننده تیپ را کور کرد بنابراین محقق اول روش تیپینگ را اعمال خواهد کرد در حالی که محقق دوم به عنوان ارزیابی کننده داده ها کور می باشد. آنالیز کننده داده ها که همان محقق اول است نیز کور می باشد.
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  • Primary outcomes

    #1
    Visual Analogue Scale (VAS)
    Visual Analogue Scale (VAS) and Short-form McGill Pain Questionnaire
    مقیاس اندازه گیری چشمی
    مقیاس اندازه گیری چشمی و فرم کوتاه شده پرسشنامه درد مک گیل
    #2
    Oswestry Questionnaire
    Oswestry disability Questionnaire
    پرسشنامه اسوستری
    پرسشنامه ناتوانی اسوستری
    #3
    Muscle thickness change
    contraction ratio
    تغییرات ضخامت عضلانی
    نسبت انقباضی
    #4
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    resting and contracted thickness
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    ضخامت استراحت و انقباض
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    Before and 72 hours after intervention
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    قبل و 72 ساعت بعد از مداخله
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    Using an ultrasound cursor, the thickness of each muscle is determined in millimetres
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    با استفاده نشانگر دستگاه سونوگرافی ضخامت هر عضله بر حسب میلیمتر مشخص میشود

  • Secondary outcomes

    #1
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    Lumbar proprioception
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    حس عمقی کمر
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    Before and 72 hours
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    قبل و 72 ساعت بعد از مداخله
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    Measurements of lumbar repositioning error (45 and 60 degree of flexion and 15 degree of extension) using double bubble inclinometer
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    اندازه گیری میزان خطای بازسازی در زوایای 45 و 60 درجه خم شدن کمر و 15 درجه راست شدن کمر با استفاده از دو شیب سنج حبابی

  • Intervention groups

    #1
    گروه مداخله: تیپینگ عضلات کمری و شکمی انجام می‌شود.
    گروه مداخله: کینزیوتیپینگ عضلات کمری و شکمی انجام می‌شود.
    #2
    N/A
    Placebo
    Control group: Placebo taping is used for the control group.
    Placebo group: Placebo taping is used for the lumbar and abdominal muscles
    گروه کنترل: از تیپینگ پلاسبو استفاده می‌شود.
    گروه پلاسبو: از تیپینگ پلاسبو برای عضلات شکمی و کمری استفاده می‌شود.
    #3
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    N/A
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    Control group: without taping
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    گروه کنترل: بدون اعمال تیپ

Protocol summary

Study aim
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
Change the number of groups, outcome measures and end of the study
Acronym
IRCT registration information
IRCT registration number: IRCT20090301001722N20
Registration date: 2018-05-21, 1397/02/31
Registration timing: prospective

Last update: 2020-05-17, 1399/02/28
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
2018-06-05, 1397/03/15
Expected recruitment end date
2018-12-06, 1397/09/15
Actual recruitment start date
2018-07-06, 1397/04/15
Actual recruitment end date
2018-12-21, 1397/09/30
Trial completion date
2018-12-21, 1397/09/30
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
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Actual sample size reached: 56
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 (00-30), placebo (30-60) and control group or without tape (60-90). 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 or control). Due to the nature of the interventions it was not be possible to blind the researcher. So, the first researcher will apply the typing method, while the second researcher will be blind as the data evaluator. Data analyzer is also blind who is first researcher.
Placebo
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) and Short-form McGill Pain Questionnaire

2

Description
Disability index
Timepoint
Before and 72 hours after intervention
Method of measurement
Oswestry disability Questionnaire

3

Description
contraction ratio
Timepoint
Before and 72 hours after intervention
Method of measurement
In formula

4

Description
resting and contracted thickness
Timepoint
Before and 72 hours after intervention
Method of measurement
Using an ultrasound cursor, the thickness of each muscle is determined in millimetres

Secondary outcomes

1

Description
Lumbar proprioception
Timepoint
Before and 72 hours
Method of measurement
Measurements of lumbar repositioning error (45 and 60 degree of flexion and 15 degree of extension) using double bubble inclinometer

Intervention groups

1

Description
Intervention group: Kinesio taping of the lumbar and abdominal muscles is performed
Category
Treatment - Other

2

Description
Placebo group: Placebo taping is used for the lumbar and abdominal muscles
Category
Placebo

3

Description
Control group: without taping
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
Analytic Code
Not applicable
Data Dictionary
Not applicable
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