- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04061174
Effects of Shoulder Stabilization Exercises in the Office Workers With Shoulder Protraction
A Comparison of the Effects of Shoulder Stabilization Exercises in Addition to Office Exercises on Scapular Dyskinesis, Muscle Strength, Posture and Proprioceptive Sensory Parameters in the Office Workers With Shoulder Protraction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is planned so that scapular dyskinesia, muscle strength, posture and proprioceptive sense measurements will be taken at 3 different times (before treatment, 8th week and 12th week) for two independent groups (control and experimental groups).Based on the proprioception sense findings in our previous pilot study, the intergroup effect size was predicted to be approximately 0.35 (weak to moderate). Assuming that type I error is 5%, type II is 20%, and the correlation between repeated measurements is 80% (high correlation), the total sample size obtained with the help of G Power 3.1.9.2 software is calculated as 60 people. Individuals are randomly divided into two groups (by blocking method). Groups are matched by stratified random sampling/proportionate distribution by degree of shoulder protraction (acromion level below and above 6.5 cm) and gender.
Study data will be analyzed using the statistical software [Statistical Package For The Social Sciences Software (SPSS 25.0)].Frequency and percentage for continuous data, mean, standard deviation, minimum and maximum value for categorical data will be reported. Independent sample t-test to determine the difference according to the groups in continuous variables, analysis of variance in repeated measures to determine the change over time, two-way analysis of variance in repeated measures with repetitions on a single factor to evaluate the group and time change together. Pearson chi-square and Fisher-Freeman-Halton test will be performed model to evaluate the difference according to groups in categorical variables. Bonferonni correction will be used for multiple comparisons, Friedman S and Cochran Q tests will be used to evaluate time-dependent variation, and two-way analysis of variance will be used for repeated measures with repetitions on a single factor to evaluate group and time variation together.The significance level will be accepted as 0.05.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Mersin 10 Turkey
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Famagusta, Mersin 10 Turkey, Cyprus, 99628
- Eastern Mediterranean University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 25-40 age range
- Participants that working at the desk for at least 1 year and more than 4 hours per day
- Participants with The Disabilities of the Arm, Shoulder and Hand Score of 15 or less
- Participants with pain severity of neck and upper extremity is 2 cm or less on visual analog scale in the last 6 months
Exclusion Criteria:
- Participants with disc herniation, spondylisthesis, degenerative arthritis or related surgery
- Participants with rotator cuff injury, acromioclavicular separation, dislocation and related surgical operations
- Participants with problems such as diabetes, rheumatoid arthritis, ankylosing spondylitis, severe osteoarthritis
- Participants who have received physiotherapy for the neck and upper extremity in the last 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Shoulder stabilization exercise and office exercise training
Shoulder stabilization exercises will be given to the experimental group participants individually during 8 weeks.
Exercises will be done 3 times a week and each exercise will be performed with 10 repetitions, 3 sets and 60-90 seconds rest between sets.
Also experimental group participants will do office exercise training that given to other group participants.
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When participants are able to do the exercise 15 repetitions without difficulty, the exercise will be advanced by modifying or adding the weight.The exercises include chin tulk exercise, shoulder closed chain weight transfer, prone and iso-abdominal exercises, push-up exercise, lower trapezius muscle strengthening exercise, dead bug exercise, ball rolling on the wall, bench press with dumbbell and internal/external rotation (IR / ER) strengthening exercises
Other Names:
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Experimental: Office exercise training
Office-based stretching exercises will be given to other group 3 sets will be applied by waiting 15 seconds for increasing range of motion of back, shoulder and neck joints. In addition, isometric exercises and scapula stabilization exercises will be given to strengthen the shoulder muscles and participants will do these exercises 3 times a week and once a day in 10 repetitions (10-15 seconds) and 3 sets. Each set will be given a rest of 60-90 seconds. Total time will be 10-15 minutes.Office exercise training will last a total of 8 weeks. |
Information will be given in a brochure that includes the appropriate chair height and work table, sitting position, distance between eyes and monitor, and table chair dimensions.approved and standardized office-based stretching and strengthening exercises will be given for workplaces
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Assessment of shoulder proprioception sense
Time Frame: 15 minute
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Evaluation of shoulder proprioception will be performed with an isokinetic (Cybex Norm) dynamometer that is found as the most reliable method of shoulder proprioception measurement.Functionally, a proprioceptive testing device (PTD) will be used to measure kinesthesia as the threshold to detect passive motion and measure joint position sense by the ability to reproduction of passive positioning and reproduction of active positioning
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15 minute
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Assessment of shoulder vibration sense
Time Frame: 5 minute
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Shoulder vibration sense evaluation will be performed with Vibrometer (Diabetic Foot Care, India), which has demonstrated high reproducibility and reliability.
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5 minute
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Rapid upper limb assessment (RULA) tool
Time Frame: 5 minute
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Ergonomic risk factors will be determined through direct observation of employees' postures by the dominant side in their workplace using the RULA tool.
RULA assesses biomechanical and postural loading on the upper limbs.
It is divided into two segments (A and B).
Segment A includes steps regarding the assessment of upper arm, lower arm and wrist, whereas segment B is related with the assessment of neck, trunk and legs.
Zero and 1 points were added to A and B scores by depending on the muscle use (static postures held for longer than one minute or repeated more than four times per minute) and force (total hours of work in a day) and consequently C and D scores were achieved.
Then, C and D scores were combined in a table to obtain a Grand Score.
The grand score ranges from 1 to 7 in which a score of 1 or 2 is acceptable, a score of 3 or 4 needs further investigation, 5 or 6 needs investigation and changes sooner and a score of 7 needs immediate investigation and change.
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5 minute
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Pectoralis minor length measurement
Time Frame: 2 minute
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Participants will be instructed to stand in a normal, relaxed posture during data collection.
The examiner palpate the medial-inferior angle of the coracoid process of the scapula and just lateral to the sternocostal junction of the inferior aspect of the fourth rib and measured the distance between these landmarks with caliper.
Three measurements will be taken; the average is divided by the participant's height and multiplied by 100 to calculate the pectoralis minor length index for analysis
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2 minute
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Passive internal rotation (IR) and external rotation (ER) mobility flexibility
Time Frame: 5 minute
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Using standard goniometer techniques, passive shoulder IR and ER with the subject supine and the arm abducted 90˚, elbow flexed to 90 ˚and the forearm in neutral rotation.
Passive ER will be measured by moving the subject's extremity into ER, maintaining positions of the abduction, elbow flexion and forearm rotation.
The extremity will be rotated externally until end range of motion is obtained.
To measure IR, the subject's arm is internally rotated while an anterior force will be applied to the coracoid and humerus to ensure that scapular compensation don't occur.
All measurements will be taken three times, and a mean of the three measurements will be calculated in degree.
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5 minute
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Active internal rotation (IR) and external rotation (ER) mobility flexibility
Time Frame: 5 minute
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Spinous process of the cervical 7 (C7) and thoracic 5 (T5) vertebra will be identified as reference points.
The subject is standing with feet shoulder width apart.
With thumb extended, the subject reached extremity upwards and towards the midline to a maximum hand behind back position.
Tape measure will be used to record the distance in centimetres from the thumb tip to T5 spinous process for active IR mobility.
Also subject will be asked to make maximum external rotation by moving harm behind neck with the thumb pointing down and the distance from thumb to C7 will be measured with tape measure for active ER mobility.
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5 minute
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Muscle Strength Measurement
Time Frame: 40 minute
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Upper, middle and lower trapezius, anterior, middle and posterior deltoid, serratus anterior, supraspinatus, infraspinatus, latissimus dorsi and pectoralis major-minor muscle strength measurement will be performed by hand-held dynamometer.3
repetitions at 30 seconds intervals and the average value will be recorded.
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40 minute
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Closed Kinetic Chain Upper Extremity Stability test
Time Frame: 5 minutes
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The Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST) is examining upper limb stability.
It consists of counting how many times the subject performs alternating touches on the opposite hand in a closed kinetic chain position (push-up) over 15 seconds, with three trials.
The normalized score is obtained by dividing the number of touches by subject height.
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5 minutes
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Passive glenohumeral (GH) horizontal adduction mobility flexibility
Time Frame: 5 minutes
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To assess GH horizontal adduction, subjects are positioned supine with both shoulders flush against a standard examination table.
Shoulder and elbow is in 90˚ of both abduction and flexion.
The tester's passively move the humerus into horizontal adduction.
To measure GH horizontal adduction, the digital inclinometer is aligned with the ventral midline of the humerus.
The angle is created by the end position of the humerus with respect to 0˚ of horizontal adduction (perpendicular plane to the examination table, as determined by the digital inclinometer) is then recorded as the total amount of GH horizontal adduction motion in degree.
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5 minutes
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Total scapula distance
Time Frame: 2 minutes
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The distance from the anterior aspect of the acromion to the T3 spinous process will be measured with a caliper while the subject is standing in a relaxed position.
Distance will be recorded in cm
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2 minutes
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Scapula upward rotation measurement
Time Frame: 10 minutes
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All subjects will assessed in a relaxed, standing (barefoot) position and asked to perform full extension at the elbow, neutral wrist position, and with the thumb leading in the coronal plane.
One inclinometer will be attached parallel to the humerus with use of a tape.
Scapular upward rotation will be measured using the second inclinometer.
Subjects are asked to actively move their arms (dominant or non-dominant randomly) from rest position to 45˚, from rest position to 90˚and from rest position to 135˚ abduction and to hold arm in these positions for measurement (measured with first inclinometer) in frontal plane (randomly).
Three trials with a 30 s rest between trials wiil be performed for each shoulder (at rest position, 45˚, 90˚ and 135˚ abduction) and means of them will be calculated.
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10 minutes
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Lateral Scapular Slide Test (LSST)
Time Frame: 5 minutes
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LSST will be used for assessing scapular asymmetry under varying load positions.
Measurements of scapular position are taken while scapular position with the arm abducted 0, 45, and 90 degrees in the coronal plane.
Distance from the inferior angle of the scapula to the spinous process of the thoracic vertebra in the same horizontal plane will be measured in all 3 position.
If the distance is greater than 1.5cm, it means LSST is positive.
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5 minutes
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Cervical posture analysis by photographing method
Time Frame: 10 minutes
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Tripod and camera (Canon Rebel T5i, 18.0 megapixel) will be located 0.8 meters away from the participant, at C7 alignment in a position, where the lens of the camera will be vertical to the individual's sagittal level.
Reflective markers will be placed on the lateral canthus of the eye, the tragus of the ear, the spinous process of C7.
The sagittal head angle will be formed at the intersection of a horizontal line through the tragus of the ear and a line joining the tragus of the ear and the lateral canthus of the eye.
The cervical angle is highly reliable to assess the forward head position.
It is the angle formed at the intersection of a horizontal line through the spinous process of C7 and a line to the tragus of the ear.
Triangular screen ruler program will be used for calculate angles.
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10 minutes
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Sagittal shoulder posture analysis by photographing method
Time Frame: 10 minutes
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Tripod and camera (Canon Rebel T5i, 18.0 megapixel) will be located 0.8 meters away from the participant, at C7 alignment in a position, where the lens of the camera will be vertical to the individual's sagittal level.
Reflective markers will be placed on the the spinous process of C7 and lateral shoulder.
Where a horizontal line passing through the lateral shoulder meets the line drawn from C7 to the lateral shoulder, the point of intersection forms the sagittal shoulder-C7 angle.
It indicates the degree of roundedness of the shoulders.
A protracted shoulder would yield a lesser value of this angle.
Triangular screen ruler program will be used for calculate angle.
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10 minutes
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Coronal shoulder posture analysis by photographing method
Time Frame: 10 minutes
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Tripod and camera (Canon Rebel T5i, 18.0 megapixel) will be located 0.8 meters away from the front of participant.
Reflective markers will be placed on the left and right coracoid processes.
It is defined as the angle between a horizontal line and a line joining the coracoid processes.
It is used to determine whether the left and the right shoulders are level or not.
Its normal value should be 180 degrees.
Triangular screen ruler program will be used for calculate angle.
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10 minutes
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Thoracic posture analysis by photographing method
Time Frame: 10 minutes
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Tripod and camera (Canon Rebel T5i, 18.0 megapixel) will be located 0.8 meters away from the participant, at C7 alignment in a position, where the lens of the camera will be vertical to the individual's sagittal level.
Reflective markers will be placed on the spinous process of C7 and the spinous process of thoracic 12 (T12).
The point where lines (perpendicular to the skin surface) produced through T12 and C7 markers intersect each other forms the thoracic flexion angle.
The lesser the value, the less is the kyphosis.
Triangular screen ruler program will be used for calculate angle.
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10 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ozde Depreli, Eastern Mediterranean University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ODepreli
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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