Protocol summary
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Study aim
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Comparison the addition of respiratory exercises to corrective exercises on pain, electromyography, posture, and respiratory pattern in Smartphone users with forward head posture and non-specific chronic neck pain
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Design
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Randomized control trial, With parallel groups, Double blind, randomized
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Settings and conduct
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60 subjects with forward head posture and Non-specific chronic neck pain that met the inclusion criteria was randomly divided into three intervention groups (Corrective _ Respiratory Exercise Group, Corrective Exercise Group and Control Group). Groups Training interventions will be performed 3 sessions per week for 8 weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: 20-30 year old students, 2 to 4 hours of smartphone use per day, With non-specific chronic neck pain averaging between 3 and 7 out of 10 on the Visual Analog Scale (VAS) scale in the past 3 months, Having a forward head and shoulder posture less than 50 degrees, body Math Index (BMI) between 19 and 25.
Exclusion criteria: History of bone fracture, Neuromyopathy, Inflammation or inflammation of the spinal cord, History of spinal cord injury and surgery, Cardiovascular disease, Trauma, Hypertension, Respiratory disorders, smoking habit, Nerve deficiency,Poor public health, Chronic lung disease, MS.
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Intervention groups
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Combining Corrective Exercises with Respiratory Exercises 2. Corrective Exercises 3. Daily Activities
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Main outcome variables
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Pain,Posture of head and neck, Electromyography of superficial neck muscles (upper trapezius, sternocleidomastoid, scalene, diaphragm and spine neck erector) and Respiratory pattern
General information
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Reason for update
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To enter the start and end dates of the disease
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200212046469N1
Registration date:
2020-03-04, 1398/12/14
Registration timing:
prospective
Last update:
2020-10-18, 1399/07/27
Update count:
4
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Registration date
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2020-03-04, 1398/12/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-03-10, 1398/12/20
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Expected recruitment end date
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2020-05-09, 1399/02/20
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Actual recruitment start date
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2020-03-10, 1398/12/20
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Actual recruitment end date
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2020-05-09, 1399/02/20
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Trial completion date
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2020-08-10, 1399/05/20
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Scientific title
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Comparison the addition of respiratory exercises to corrective exercises on pain, electromyography, posture, and respiratory pattern in Smartphone users with forward head posture and non-specific chronic neck pain
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Public title
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Comparison the addition of respiratory exercises to corrective exercises on pain, electromyography, posture, and respiratory pattern in Smartphone users with forward head posture and non-specific chronic neck pain
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
20-30 year old students
2 to 4 hours of smartphone use per day
Non-specific chronic neck pain ranging from 3 to 7 out of 10 on the VAS scale in the past 3 months
Having a forward head and shoulder posture with an angle of less than 50 degrees
BMI between 19 and 25
Exclusion criteria:
History of bone fractures
Neuromyopathy
Infection or inflammatory arthritis in the cervical spine
History of spinal cord injury and surgery
trauma
Hypertension
Respiratory disorders
Smoking habit
Nerve defect
Poor public health
Chronic pulmonary disease
MS
Cardiovascular diseases
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Age
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From 20 years old to 30 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Balanced block randomization
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The outcome evaluator, participant, researcher, and data analyst are kept blind.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-09-30, 1398/07/08
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Ethics committee reference number
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IR.KHU.REC.1398.023
Health conditions studied
1
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Description of health condition studied
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Forward head posture
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ICD-10 code
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R29.3
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ICD-10 code description
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Abnormal posture
2
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Description of health condition studied
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Chronic neck pain
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ICD-10 code
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G89.29
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ICD-10 code description
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Other chronic pain
Primary outcomes
1
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Description
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Pain
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Timepoint
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Before and after the intervention
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Method of measurement
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VAS
2
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Description
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Forward head angle
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Timepoint
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Before and after the intervention
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Method of measurement
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Photogrammetry
Secondary outcomes
1
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Description
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Muscle Activity Level 1- Upper Trapezius 2- Sternocleidomastoid 3- Scalene 4- Neck Erector Spine 5- Diaphragm
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Timepoint
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Before and after the intervention
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Method of measurement
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Electromyography device
2
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Description
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Onset of muscle activity 1. Upper trapezius, 2. Sternocleidomastoid 3. Scalene 4. neck erector Spine 5. Diaphragm
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Timepoint
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Before and after the intervention
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Method of measurement
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Electromyography device
3
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Description
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Respiratory pattern
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Timepoint
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Before and after the intervention
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Method of measurement
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Manual Assessment of Respiratory Motion (MARM)
Intervention groups
1
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Description
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Intervention group: combination of corrective exercises and respiratory exercises, One session a day, three sessions a week, for eight weeks
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Category
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Rehabilitation
2
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Description
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Intervention group: Corrective Exercises, One session a day, three sessions a week, for eight weeks
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Category
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Rehabilitation
3
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Description
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Control group: Doing daily activities
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kharazmi University
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Proportion provided by this source
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20
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Only part of the data, such as the dependent variables, The average of all samples, can be shared in scientific articles.
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When the data will become available and for how long
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The date of access is August 2020.
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To whom data/document is available
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Personal information is confidential and general results are available to anyone in the article.
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Under which criteria data/document could be used
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Information is not available to anyone. general results are available to anyone in the article.
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From where data/document is obtainable
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Hamid Rezaee darehdeh 0098 9353872375 - Email: std-h.rezaee@khu.ac.ir
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What processes are involved for a request to access data/document
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Comments
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