Protocol summary
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Study aim
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The effect of throwers ten exercises on neck pain, disability, scapular position and function of basketball players in Shiraz and Isfahan, 2018
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Design
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Randomized controlled clinical trial, double blinded, parallel group design, 36 patients
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Settings and conduct
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Shiraz and Isfahan gyms, Throwers ten exercises will be given to the intervention group (before sport exercises).Control group do only the routine sport exercises. For both groups, the pain (VAS), functional disability level (NDI), scapular position (Lateral scapular slide test and the distance between acromion posterior part and the lying area), performance test (basketball shoot precision test) will be measured (before, 3 and 6 weeks after initiation and 4 weeks after the termination of interventions). The examiner will not know about the study groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age 18-30 Y/O, pain in Shoulder and neck during throwing, minimum and maximum duration of pain: one month and six months respectively, last week average pain: minimum of 30 mm (VAS), maximum was at a level that would not result in exercise interruption, absence of a history of shoulder and neck trauma which has led to exercise interruptions for more than 24 hours in a month.
Exclusion criteria: history of cervical disks, repeated shoulder dislocation, fracture in the shoulder and neck, Pain following spinal surgery, rheumatic diseases, receiving physiotherapy during last month due to neck pain.
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Intervention groups
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Intervention group: Throwers ten exercises; designed to improve strength, power, and endurance of shoulder complex musculature (besides the athletes routine sport exercises)
Control group: No intervention (athletes do only the routine sport exercises).An exercise brochure will give them after finishing the study.
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Main outcome variables
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Neck pain; functional disability; scapular position; throwing function
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20181006041246N1
Registration date:
2018-12-24, 1397/10/03
Registration timing:
prospective
Last update:
2019-01-26, 1397/11/06
Update count:
1
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Registration date
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2018-12-24, 1397/10/03
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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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2019-02-09, 1397/11/20
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Expected recruitment end date
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2019-05-10, 1398/02/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of throwers ten exercises on neck pain, disability, scapular position and function of male basketball players
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Public title
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The effect of throwers ten exercises on neck pain, disability, scapular position and function of male basketball players
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age between 18 to 30 years old
Athletes has pain at Shoulder and neck during throwing
At least one month and a maximum of six months from the onset of pain
Last week average pain: minimum of 30 mm (VAS), maximum was at a level that would not result in exercise interruption
The absence of a history of trauma has led to discomfort in the shoulder and neck, resulting in interruptions in exercise for more than 24 hours in a month and the lack of remaining problems.
Exclusion criteria:
Having a history of cervical disks
History of repeated dislocation of shoulder
History of malignancy
History of fracture in the shoulder and neck region
Pain followed by spinal surgery, rheumatic and inflammatory diseases
Receiving physiotherapy during last month due to neck pain.
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Age
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From 18 years old to 30 years old
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Gender
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Male
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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:
36
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Individuals entered into the study after the completion of the informed consent form are divided into two groups; test and control. The research randomization software and the permutation block method will be used to randomly divide the subjects to the two groups.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this test, training exercises will be conducted by a physiotherapist and the tests will be done by another physiotherapist. Also the physiotherapist who will done the tests will not know the about the participants group.
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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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2018-09-26, 1397/07/04
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Ethics committee reference number
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IR.SUMS.REC.1397.513
Health conditions studied
1
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Description of health condition studied
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Neck pain
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Neck pain in Visual Analogue Scale index
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Timepoint
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Neck pain measurement at the beginning of the study (before the intervention) and 3, 6 and 10 weeks after the intervention
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Method of measurement
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Measuring of pain by the Visual Analogue Scale index
Secondary outcomes
1
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Description
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Functional Disability Level
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Timepoint
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At the beginning of the study (before the intervention) and 3, 6 and 10 weeks after the intervention began
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Method of measurement
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Neck Disability Index
2
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Description
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Function of athletes
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Timepoint
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At the beginning of the study (before the intervention) and 3, 6 and 10 weeks after the intervention began
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Method of measurement
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Basketball shoot precision test
3
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Description
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The scapular position test
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Timepoint
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At the beginning of the study (before the intervention) and 3, 6 and 10 weeks after the intervention began
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Method of measurement
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Assessment of the distance between acromion posterior part and the lying area, as well as assessing the Lateral scapular slide test in 3 situation
Intervention groups
1
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Description
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Intervention group: Before the regular team exercises, they carry out the Throwers ten exercises. This group performs the exercises three times a week for 6 weeks each 3 sets 10 repetitions of each exercise. After 3 weeks, as well as at the end of 6 weeks, the participants are evaluated in terms of variables such as pain, functional disability, scapular bone positioning, and basketball throwing accuracy testing. Also, to evaluate the effect of treatment survival, 4 weeks after the intervention in the test group, the evaluations will be carried out again. Throwers ten exercises are designed to practice the great muscle needed for throwing action. All of these exercises are specifically designed for throwers to increase the strength, strength, and endurance of the shoulder muscle complex. What is needed in these exercises includes a dumbbell weighing two pounds, a lightweight trabund, and a towel. For each exercise, a set of ten repetitions is recommended once or twice a week. Do not feel pain during or after exercises
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Category
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Rehabilitation
2
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Description
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Control group: The control group does not practice any exercise before regular team training and there is no intervention until the end of the study. After the end of the study, the controlling group is trained by a physiotherapist.
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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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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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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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Not applicable
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The results will be published as an article in the research international journals
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When the data will become available and for how long
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In the next 1 to 2 years
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To whom data/document is available
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Only people who ask the main investigator for the information
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Under which criteria data/document could be used
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With the permission through a written or oral request
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From where data/document is obtainable
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School of Rehabilitation Sciences. Shiraz University of Medical Sciences
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What processes are involved for a request to access data/document
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With a written request, they can access the library of Shiraz University of Medical Sciences, School fo rehabilitation Sciences
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Comments
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