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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04061174
Other study ID # ODepreli
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date August 1, 2021

Study information

Verified date March 2022
Source Eastern Mediterranean University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Office workers continuously work with the forward head posture. Forward head posture may cause upper extremity problems in the office workers due to the increase in the load on the muscles and joints of the cervical spine. This working posture may cause scapular rotation downward, increase in activation of the scapular muscles, pain, limited range of motion (ROM) and poor proprioception, which can create a vicious circle. Especially in the office workers that using computer vibration sensation reduction and upper extremity problems are seen. The aim of this study is to investigate the effect of shoulder stabilization exercises on scapular dyskinesis, muscle strength, posture and proprioceptive sensory parameters in addition to office exercises in the office workers with shoulder protraction.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date August 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Shoulder stabilization exercises
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
Office exercises training
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

Locations

Country Name City State
Cyprus Eastern Mediterranean University Famagusta Mersin 10 Turkey

Sponsors (1)

Lead Sponsor Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of shoulder proprioception sense 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 15 minute
Primary Assessment of shoulder vibration sense Shoulder vibration sense evaluation will be performed with Vibrometer (Diabetic Foot Care, India), which has demonstrated high reproducibility and reliability. 5 minute
Secondary Rapid upper limb assessment (RULA) tool 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. 5 minute
Secondary Pectoralis minor length measurement 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 2 minute
Secondary Passive internal rotation (IR) and external rotation (ER) mobility flexibility 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. 5 minute
Secondary Active internal rotation (IR) and external rotation (ER) mobility flexibility 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. 5 minute
Secondary Muscle Strength Measurement 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. 40 minute
Secondary Closed Kinetic Chain Upper Extremity Stability test 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. 5 minutes
Secondary Passive glenohumeral (GH) horizontal adduction mobility flexibility 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. 5 minutes
Secondary Total scapula distance 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 2 minutes
Secondary Scapula upward rotation measurement 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. 10 minutes
Secondary Lateral Scapular Slide Test (LSST) 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. 5 minutes
Secondary Cervical posture analysis by photographing method 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. 10 minutes
Secondary Sagittal shoulder posture analysis by photographing method 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. 10 minutes
Secondary Coronal shoulder posture analysis by photographing method 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. 10 minutes
Secondary Thoracic posture analysis by photographing method 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. 10 minutes
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