Investigating and comparing McKenzie exercise and kinesio taping effect on performance of upper Trapezius, Sternoclidomastoid and cervical erector spinae muscles while using smartphone
Design
A randomised, crossover, controlled clinical trial with blinded data analyser. Randomisation for sequences of allocating the participants to different groups will be done by https://statpages.info/latinsq.html website
Settings and conduct
The study will be done in biomechanics laboratory of rehabilitation school of Tehran university of medical sciences. Discomfort and disability will be measured by Numeric Rating Scale and Neck Disability index questionaires. Muscles activity will be measured by surface electromyography. It is a crossover study and data analyser will be blinded; because data will be coded so that the allocation of data will be unknown.
Participants/Inclusion and exclusion criteria
Participants will be healthy and rihgt handed smartphone users who aged 18-40 years old. They should not be affected by musculoskeletal, visual or auditory disorders
Intervention groups
Participants in control group will text by a smartphone for 15 minutes and after 1 minute rest will continue the activity for 15 minutes. In McKenzie group participants will do the same task as control group, but instead of passive rest they will do McKenzie exercises. In kinesio taping group before beginning the task taping will be done, task and resting will be the same as control group
Main outcome variables
Discomfort; type of muscle performance; fluctuation slope of median frequency; fluctuation slope of root mean square of electromyographic values
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220226054127N1
Registration date:2022-04-09, 1401/01/20
Registration timing:prospective
Last update:2022-04-09, 1401/01/20
Update count:0
Registration date
2022-04-09, 1401/01/20
Registrant information
Name
Ehsan Naeimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3825 0433
Email address
naeimiehsan.pt@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-14, 1401/01/25
Expected recruitment end date
2022-07-16, 1401/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between McKenzie exercise and kinesio taping effect onelectrophysiological parameters of cervical muscle performance in smartphone users
Public title
A comparison between McKenzie exercise and kinesio taping effect onelectrophysiological parameters of cervical muscle performance in smartphone users
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Using smartphone
Right handed
Neck disability index lower than 10 percent or 5 score
18-40 years old
Exclusion criteria:
Neck or shoulder pain problem
Upper extremity radicular pain
Upper extremity numbness
History of chronic neck, sholder, back or leg pain
Auditory disorders
Eye disoders including ocular surface disorder and computer vision syndrome
Visual weakness
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will attend in laboratory in different 3 days. Sequence of allocation of the participants to 3 groups will be defined by https://statpages.info/latinsq.html website. In this website 6 sequences (ABC, BCA, CAB, CBA, ACB, BAC) is defined based on Williams square design. Each time one of them will be chosen by chance.
Blinding (investigator's opinion)
Single blinded
Blinding description
Examiner will gather data, then will send them to advisor, she allocate a code to each data and send them to analyser, so the analyser will be blinded.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o
Street address
School of Rehabilitation of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1148965111ehran
Approval date
2022-02-23, 1400/12/04
Ethics committee reference number
IR.TUMS.FNM.REC.1400.212
Health conditions studied
1
Description of health condition studied
Cervical muscle fatigue
ICD-10 code
Z57
ICD-10 code description
Occupational exposure to risk factors
Primary outcomes
1
Description
Fluctuation slope of median frequency
Timepoint
Beginning the task and every 2 minutes
Method of measurement
Surface electromyography
2
Description
Fluctuation slope of root mean square
Timepoint
Beginning the task and every 2 minutes
Method of measurement
Surface electromyography
Secondary outcomes
1
Description
Type of muscle performance
Timepoint
Beginning the task and every 2 minutes
Method of measurement
Surface electromyography instrument and Joint Analysis of Spectrum and Amplitude
2
Description
Neck disability index
Timepoint
Before and after doing the task
Method of measurement
Persian neck disability index questionaire
3
Description
Numeric rating scale
Timepoint
Before and after doing the task
Method of measurement
Numeric Rating Scale questionaire
4
Description
Neck flexion angle
Timepoint
Every 2 minutes
Method of measurement
Imaging and measuring the angle by Kinovea software
5
Description
Head flexion angle
Timepoint
Every 2 minutes
Method of measurement
Imaging and measuring the angle by Kinovea software
Intervention groups
1
Description
Control group: Participants text with a smartphone for 15 minutes, then they rest for 1 minute, afterwards they continue the task for 15 minutes.
Category
Prevention
2
Description
First intervention group: Participants text with a smartphone for 15 minutes, then they do 2 McKenzie exercises for 1 minutes, afterwards they continue the task for 15 minutes.
Category
Prevention
3
Description
Second intervention group: Before Beginning of the task Kinesio Tapes are attached to cervical region of participants by a specific method, then they text with a smartphone for 15 minutes, then they rest for 1 minute, afterwards they continue the task for 15 minutes.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation School of Tehran University of Medical Sciences
Full name of responsible person
Ehsan naeimi
Street address
School of Rehabilitation, Piche shemiran, Enghelab street, Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
naeimiehsan.pt@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotoohi
Street address
Sixth floor, Central Organization of Tehran University of Medical Sciences, Qods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@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
Ehsan Naeimi
Position
PhD. Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation of Tehran University of Medical Sciences, Piche-shemiran, Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 81 3825 0433
Fax
Email
naeimiehsan.pt@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Gholamreza Olyaei
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Physiotherapy department, School of Rehabilitation of Tehran University of Medical Sciences, Piche Shemiran, Enghelab street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 0670
Email
olyaeigh@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Naeimi
Position
PhD. Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation of Tehran University of Medical Sciences, Piche-shemiran, Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 81 3825 0433
Fax
Email
naeimiehsan.pt@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available