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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03678623
Registration number
NCT03678623
Ethics application status
Date submitted
9/09/2018
Date registered
19/09/2018
Date last updated
4/05/2021
Titles & IDs
Public title
The Impact of Prolonged Standing on Musculoskeletal Pain
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Scientific title
Exploring the Impact of Standing on the Musculoskeletal System of Sedentary-workers
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Secondary ID [1]
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Standing-musculoskeletal pain
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal Pain
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Occupational Exposure
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Office Workers
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Office-based workers - Individuals working in an office environment with their main tasks involving use of a computer, reading, phoning, making presentations and participating in meetings, who perform more than 30 hours per week mostly sitting at a computer.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Standing Tolerance Test (STT)
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Assessment method [1]
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The Standing Tolerance Test consists of participants standing for 1-hour while performing computer tasks using a workstation table.They are required to stand in a confined working area marked on the ground (60x122 cm). During the 1-h period, participants are instructed to adopt a comfortable position that they would normally use if they are to stand for a prolonged period of time. The participant are not allowed to lean on the workstation in any way. The working surface for each participant is adjusted to a height of 5 cm below elbow height. Participants rate their musculoskeletal symptoms intensity on a scale from 0 to 100 mm visual analogue scale (VAS) prior to the start of, every 15 minutes during, and at the end of the 1-h standing period. Based on their VAS rating for spine, lower and upper limb, they are classified either as a Pain Developers (PDs) if they report a change in VAS of 1 or more from baseline on 0-100 scale (whatever baseline is) or a Non-Pain Developers (NPDs).
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Timepoint [1]
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Baseline
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Secondary outcome [1]
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Demographic characteristics:
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Assessment method [1]
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Date of birth, gender, height, weight and smoking habits are recorded
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Timepoint [1]
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Baseline
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Secondary outcome [2]
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Occupational characteristics: Occupational Sitting and Physical Activity Questionnaire (OSPAQ)
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Assessment method [2]
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Questions are about the time spent on activities at work over the past seven days, involving sitting, standing, walking and physically demanding tasks.
How many hours did you work in the last 7 days? _____ Hours
During the last 7 days, how many days were you at work? _____ Days
How would you describe your typical work day in the last 7 days? (This involves only your work day, and does not include travel to and from work, or what you did in your leisure time) Please ensure your answers add up to 100.
Sitting :____%
Standing:____%
Walking: ____%
Heavy Labour or physically demanding tasks: ____% Total:____% (100%)
Scoring:
Minutes sitting at work per week = Item 1 * Item 3a Minutes sitting per workday = (Item 1/Item 2) * Item 3a Similar calculations can be done for standing, walking, and heavy labour.
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Timepoint [2]
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Baseline
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Secondary outcome [3]
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Occupational characteristics: questions about using sit-stand workstation
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Assessment method [3]
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i) Do you usually use a sit-stand workstation? Yes/No ii) How long (in month) have you had one? iii) What percentage of day do you use your sit-stand workstation?
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Timepoint [3]
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Baseline
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Secondary outcome [4]
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Occupational characteristics: Abbreviated Job Content Questionnaire (JCQ) & Job Satisfaction
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Assessment method [4]
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JCQ comprises 18 items measuring 5 dimensions related with psychosocial job characteristics: decision latitude, decision authority, psychological job demands, social support and physical job demands.
Range of scores:
Skill discretion: 12-48
Decision authority: 12-48
Phychological job demands: 3-12
Social Support: 4-16
Physical demands: 2-8 *Job control = skill discretion + decision authority: 24-96
Dichotomised physical demand and job control are combined to create four categories:
low strain: low demand and high control
active job: high demand and high control
passive job: low demand and low control
job strain: high demand and low control
Job Satisfaction: comprises 1 question:
"How satisfied are you with your work in general"?
extremely dissatisfied
very dissatisfied
rather dissatisfied
more or less satisfied
rather satisfied
very satisfied
extremely satisfied
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Timepoint [4]
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Baseline
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Secondary outcome [5]
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International Physical Activity Questionnaire (IPAQ)-Short Form
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Assessment method [5]
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Questions are about physical activities(PA) (vigorous, moderate, walking) that people do as part of their everyday lives; and about the time they spent being physically active in the last 7-days. Values are computed for walking(W), moderate-intensity-activities(M), vigorous-intensity-activities(V) and a combined total physical activity score. Scores are expressed in MET-minutes/week (METs). The following values are used for the analysis: W=3.3 METs; M=4.0 METs; V=8.0 METs. There are 3 levels of PA proposed to classify populations: Low: individuals who not meet criteria for categories 2 or 3. Moderate: a)3 or more days of V of at least 20 min per day; b)5 or more days of M and/or W of at least 30-min per day; c)5 or more days of any combination of W, M or V achieving a minimum total PA of at least 600-METs. High: a)V on at least 3 days achieving a minimum total PA of at least 1500-METs; b)7 or more days of any combination of W, M or V achieving a minimum total PA of at least 3000-METs.
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Timepoint [5]
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Baseline
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Secondary outcome [6]
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Quality of life related to health: SF12 questionnaire
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Assessment method [6]
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SF12 questionnaire. This questionnaire ask about the generic health status in 8 domains: physical function, role physical, body pain, general health, vitality, social function, role emotional and mental health. It is a shorter version of SF-36.
Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Both Physical and Mental Health Composite Scales combine the 12 items in such a way that they compare to a national norm with a mean score of 50.0 and a standard deviation of 10.0.
A positive score means the person is healthier than average. A negative score means a person is less healthy than average.
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Timepoint [6]
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Baseline
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Secondary outcome [7]
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Prevalence of musculoskeletal pain: Nordic Musculoskeletal Questionnaire (NMQ)
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Assessment method [7]
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An abbreviated version of NMQ is used, which consists of a rear view of the human body, divided into 9 anatomical regions (3 each on the upper limbs, spine and lower limbs), asking about presence of musculoskeletal pain during the last year, the last month and today.
All response options are dichotomous (yes/no). Questions are ordered in such a way that those relating to the respondents' last year are asked first, followed by prevalence questions about last month and today. Key words are highlighted in bold. Respondents are asked to answer all questions for a body region before progressing to the next region (ie, horizontally rather than vertically). If the respondent answer no for question relating to annual prevalence, they are directed to go on to the next body region and all remaining questions for that region are automatically coded as negative responses.
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Timepoint [7]
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Baseline
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Secondary outcome [8]
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Symptom intensity level of musculoskeletal pain: Visual Analogue Scale (VAS)
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Assessment method [8]
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The musculoskeletal intensity in 9 regions, over the previous 7 days, is measured with the VAS.
VAS is a continuous scale comprised of a horizontal line, 10 centimetres (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme: "no pain" (score of 0) and "worst imaginable pain" (score of 100-mm scale).
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Timepoint [8]
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Baseline
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Secondary outcome [9]
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Disability due to low back pain:
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Assessment method [9]
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Oswestry Disability Questionnaire. Lumbar functional disability is measured using this outcome assessment. It contains 10 questions about: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and traveling. The total score is expressed as a percentage (from 0 to 100). Between 0% and 20% is interpreted as minimal disability; 21% to 40% as moderate disability; 41% to 60% as severe disability; 61% to 80% as crippled; and from 81% to 100% as bed-bound, or exaggerating their symptoms.
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Timepoint [9]
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Baseline
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Secondary outcome [10]
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Catastrophizing thoughts related with pain
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Assessment method [10]
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Pain Catastrophizing Scale (PCS). This scale consists of 13 statements describing different thoughts and feelings that may be associated with pain. The participant indicate the degree to which they have these thoughts and feeling is it a 5 point scale from "not at all" to "all the time" about the experiences with painful situations.
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Timepoint [10]
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Baseline
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Secondary outcome [11]
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Thoracic and lumbar curve
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Assessment method [11]
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The flexible ruler, length 60 cm is placed over the spinous processes of the thoracic and lumbar spine so that it follows the contour of the spinal curves, from C7 to the posterior superior iliac spine (PSIS). Spinal processes of the C7 and T12 vertebras, and PSIS are identified and marked. The flexicurve is marked at C7, T12 and S2 level; then it is carefully removed, placed on a stable surface, and the internal edge (the side of the flexicurve in contact with the skin) is traced onto graph paper. Two measurements are obtained from the flexicurve.
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Timepoint [11]
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Baseline
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Secondary outcome [12]
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Motor Control Impairment test: Active hip abduction test
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Assessment method [12]
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a) Active Hip Abduction test: Side-lying position. Participants are instructed to raise their top leg towards the ceiling as far as they can. The side to be tested first is randomized. Examiner score as: 0 = Able to maintain position; 1 = Minimal loss; 2 = Moderate loss; 3 = Severe loss of pelvis position in the frontal plane.
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Timepoint [12]
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Baseline
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Secondary outcome [13]
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Motor Control Impairment test: Active straight leg raise test
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Assessment method [13]
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b) Active Straight Leg Raise test (ASLR test): Supine position, with straight legs and feet 20 cm apart. Subject is instructed to raise a straight leg 20 cm above the table. Scoring on a 6-point scale (range 0-5). Scores of both sides are added.
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Timepoint [13]
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Baseline
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Secondary outcome [14]
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Motor Control Impairment test: Prone knee flexion test
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Assessment method [14]
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c) Prone Knee Flexion test: Prone position. Instruction is "bend your knee as far as you can without moving your back". Scoring: a) correct: active knee flexion at least 90° without movement of the low back and pelvis; b) incorrect: by the knee flexion low back does not stay neutral maintained but moves in extension or rotation.
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Timepoint [14]
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Baseline
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Secondary outcome [15]
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Endurance tests of the trunk muscles (McGill's protocol): Sorensen test
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Assessment method [15]
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Trunk endurance test (McGill´s protocol 1999):
a) Sorensen test: The patient lies on the examining table in the prone position with the upper edge of the iliac crests aligned with the edge of the table. The lower body is fixed to the table by three straps, located around the pelvis, knees, and ankles, respectively.
With the arms folded across the chest, the patient is asked to isometrically maintain the upper body in a horizontal position. The time during which the patient keeps the upper body straight and horizontal is recorded. In patients who experience no difficulty in holding the position, the test is stopped after 240 s.
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Timepoint [15]
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Baseline
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Secondary outcome [16]
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Endurance tests of the trunk muscles (McGill's protocol): Abdominal endurance test
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Assessment method [16]
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Trunk endurance test (McGill´s protocol 1999):
b) Abdominal endurance test: This test is performed by having the subject sit on a test bench. Both the knees and hips are flexed at 90° and the feet are fixed to the bench with a strap. The arms crossed over the chest. At the position of 60° trunk flexion, the support of the trunk is then removed and the participant hold the position for as long as possible. The test is terminated when the participant is no longer able to hold the position.
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Timepoint [16]
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Baseline
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Secondary outcome [17]
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Endurance tests of the trunk muscles (McGill's protocol): Side bridge test
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Assessment method [17]
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Trunk endurance test (McGill´s protocol 1999):
c) Side bridge test: The side bridge test (right and left side) are performed in the side-lying position on a mat. The participant's knees are extended with the top foot placed in front of the lower foot. The participant supports their weight only on their lower elbow and feet while lifting their hips off the mat. The test is stopped when the side-lying position is lost or when the hips returned to the mat.
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Timepoint [17]
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Baseline
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Secondary outcome [18]
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Endurance tests of the trunk and hip muscles: Supine Bridge Test
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Assessment method [18]
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Supine Bridge Test:
subject is on the examination table in the supine position, with knees flexed 90 degrees and the soles of the feet on the floor.The hands are positioned by the ears. Subjects are instructed to raise the pelvis from the floor so that the shoulders, hips, and knees are maintained in a straight line. The time is held and timed until the position can no longer be maintained.
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Timepoint [18]
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Baseline
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Secondary outcome [19]
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Endurance tests of the hip muscles: Abductor Hip Endurance Test
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Assessment method [19]
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Abductor Hip Endurance Test:
in the side-lying position with the evaluated hip placed superiorly in neutral alignment and with the pelvis stabilized by straps. External weight of 7.5% of body mass, is placed on the ankle of the evaluated limb. A inclinometer is strapped 10 cm superior to the lateral femoral condyle. The subject is instructed to isometrically hold the limb in a horizontal position. The time is recorded.
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Timepoint [19]
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Baseline
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Eligibility
Key inclusion criteria
- Office-based workers who perform more than 30 hours per week mostly sitting at a
computer,
- With aged 18 or above.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- not office-based workers,
- pregnant or less than six months postpartum,
- had experienced any major trauma or had surgery to the spine or lower limb over the
last 12 months,
- had been diagnosed with any neurological or systematic pathology (such as rheumatoid
arthritis, multiple sclerosis or ankyloses spondylitis).
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Study design
Purpose
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Duration
Cross-sectional
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/04/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/09/2019
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Sample size
Target
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Accrual to date
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Final
40
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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The University of Queensland - Brisbane
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Recruitment postcode(s) [1]
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4072 - Brisbane
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Funding & Sponsors
Primary sponsor type
Other
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Name
Universidade da Coruña
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Address
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Other collaborator category [1]
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Other
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Name [1]
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The University of Queensland
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a cross-sectional and prospective cohort study using a biopsychosocial approach to
investigate office workers at risk of standing-induced musculoskeletal pain. The purpose of
this study is to determine which factors are associated with developing or worsening of
musculoskeletal pain (changes in the Visual Analogue Scale from baseline) during a 60 minute
standing paradigm.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03678623
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Trial related presentations / publications
Neuhaus M, Eakin EG, Straker L, Owen N, Dunstan DW, Reid N, Healy GN. Reducing occupational sedentary time: a systematic review and meta-analysis of evidence on activity-permissive workstations. Obes Rev. 2014 Oct;15(10):822-38. doi: 10.1111/obr.12201. Epub 2014 Jul 11.
Coenen P, Parry S, Willenberg L, Shi JW, Romero L, Blackwood DM, Healy GN, Dunstan DW, Straker LM. Associations of prolonged standing with musculoskeletal symptoms-A systematic review of laboratory studies. Gait Posture. 2017 Oct;58:310-318. doi: 10.1016/j.gaitpost.2017.08.024. Epub 2017 Aug 24.
Sorensen CJ, Johnson MB, Callaghan JP, George SZ, Van Dillen LR. Validity of a Paradigm for Low Back Pain Symptom Development During Prolonged Standing. Clin J Pain. 2015 Jul;31(7):652-9. doi: 10.1097/AJP.0000000000000148.
Marshall PW, Patel H, Callaghan JP. Gluteus medius strength, endurance, and co-activation in the development of low back pain during prolonged standing. Hum Mov Sci. 2011 Feb;30(1):63-73. doi: 10.1016/j.humov.2010.08.017. Epub 2011 Jan 11.
Nelson-Wong E, Gregory DE, Winter DA, Callaghan JP. Gluteus medius muscle activation patterns as a predictor of low back pain during standing. Clin Biomech (Bristol, Avon). 2008 Jun;23(5):545-53. doi: 10.1016/j.clinbiomech.2008.01.002. Epub 2008 Feb 20.
Zamkova MA, Krivitskaia EI. [The effect of radiation by erythema-uviol lamps on the working capacity of students]. Gig Sanit. 1966 Apr;31(4):41-4. No abstract available. Russian.
Sorensen CJ, Norton BJ, Callaghan JP, Hwang CT, Van Dillen LR. Is lumbar lordosis related to low back pain development during prolonged standing? Man Ther. 2015 Aug;20(4):553-7. doi: 10.1016/j.math.2015.01.001. Epub 2015 Jan 14.
Ringheim I, Austein H, Indahl A, Roeleveld K. Postural strategy and trunk muscle activation during prolonged standing in chronic low back pain patients. Gait Posture. 2015 Oct;42(4):584-9. doi: 10.1016/j.gaitpost.2015.09.008. Epub 2015 Sep 15.
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Public notes
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Contacts
Principal investigator
Name
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Venerina Johnston, PhD
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Address
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The University of Queensland
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03678623
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