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The Impact of Prolonged Standing on Musculoskeletal Pain

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ClinicalTrials.gov Identifier: NCT03678623
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : September 19, 2018
Sponsor:
Collaborator:
The University of Queensland
Information provided by (Responsible Party):
Beatriz Rodríguez-Romero, Universidade da Coruña

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.

Condition or disease
Musculoskeletal Pain Occupational Exposure Office Workers

Detailed Description:

Background/rationale

There is growing national and international evidence for the negative health impact of sedentary behaviour at work. A strategy being increasingly adopted to reduce prolonged sitting is to spend some of the work day in standing. However, for some adults, prolonged standing is associated with the development of musculoskeletal pain. We are investigating which factors are associated with developing of musculoskeletal pain during standing when using a height-adjustable desk. Previous studies have used an induced-pain paradigm to understand risk factors for developing musculoskeletal pain during a prolonged standing task that simulates the work environment (standing paradigm). Identifying those office workers who are at risk of developing musculoskeletal pain during standing will provide information to guide health professionals and individuals in making decisions about optimal workstation design.

Objectives and hypothesis

  • Cross-sectional study: Identify which factors are associated (demographic, physical, psychological and work-related factors) with standing-induced musculoskeletal pain in office workers during a standing paradigm.
  • Prospective cohort study: Identify incidence/prevalence and risk factors of low back pain, and disability associated with low back pain in office workers in a 1-year prospective cohort.

Methods

  • Setting, locations and relevant dates: testing is conducted in the University of Queensland (Brisbane, Australia). Data collection commenced in May of 2018 until 30th of April of 2019 (cross-sectional study); and follow-up is from June of 2018 until 30th of April of 2020 (prospective cohort study).
  • Participants: recruitment is through posting flyers on campus of The University of Queensland; through the weekly electronic university staff newsletter at this University; and through Facebook announcements. Interested participants were directed to an online questionnaire (hosted by Survey Monkey) to determine eligibility. Participants meeting the eligibility criteria were contacted via email to schedule an appointment.
  • Variables: see "outcomes measures".
  • Study size: a convenience sample of 40 office workers will be recruited. Based on previous studies that have compared developers and non-developers of standing-induced low back pain, this sample size was considered sufficient to detect a significant difference in some of the physical outcome measures such as lumbar lordosis (Sorensen et al. 2015a); trunk muscle activation (Ringheim et al. 2015) and active hip abduction (Nelson-Wong et al. 2008).
  • Statistical analysis: subjects will be separated into Pain Developers (PDs) and Non-Pain Developers (NPDs). A Chi-square analysis or a Fisher's Exact test will be conducted to test for differences in the distribution of qualitative and proportional variables in PDs and NPDs. Independent groups t-tests, will be conducted to test for differences in quantitative variables between PDs and NPDs. A Pearson correlation coefficient and one-way analysis of variance test will be conducted to test for differences for average Visual Analogue Score (VAS). A simple linear regression analysis will be performed to examine the degree to which biopsychosocial variables predict PDs. Statistical analyses will be performed in SPSS version 24 (IBM, Armonk, NY).Statistical significance for all tests will be set at p ≤ 0.05.

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Exploring the Impact of Standing on the Musculoskeletal System of Sedentary-workers
Actual Study Start Date : April 23, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2020

Group/Cohort
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.



Primary Outcome Measures :
  1. Standing Tolerance Test (STT) [ Time Frame: Baseline ]
    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).


Secondary Outcome Measures :
  1. Demographic characteristics: [ Time Frame: Baseline ]
    Date of birth, gender, height, weight and smoking habits are recorded

  2. Occupational characteristics: Occupational Sitting and Physical Activity Questionnaire (OSPAQ) [ Time Frame: Baseline ]

    Questions are about the time spent on activities at work over the past seven days, involving sitting, standing, walking and physically demanding tasks.

    1. How many hours did you work in the last 7 days? _____ Hours
    2. During the last 7 days, how many days were you at work? _____ Days
    3. 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.

      1. Sitting :____%
      2. Standing:____%
      3. Walking: ____%
      4. 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.


  3. Occupational characteristics: questions about using sit-stand workstation [ Time Frame: Baseline ]
    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?

  4. Occupational characteristics: Abbreviated Job Content Questionnaire (JCQ) & Job Satisfaction [ Time Frame: Baseline ]

    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"?

    1. extremely dissatisfied
    2. very dissatisfied
    3. rather dissatisfied
    4. more or less satisfied
    5. rather satisfied
    6. very satisfied
    7. extremely satisfied

  5. International Physical Activity Questionnaire (IPAQ)-Short Form [ Time Frame: Baseline ]
    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.

  6. Quality of life related to health: SF12 questionnaire [ Time Frame: Baseline ]

    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.


  7. Prevalence of musculoskeletal pain: Nordic Musculoskeletal Questionnaire (NMQ) [ Time Frame: Baseline ]

    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.


  8. Symptom intensity level of musculoskeletal pain: Visual Analogue Scale (VAS) [ Time Frame: Baseline ]

    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).


  9. Disability due to low back pain: [ Time Frame: Baseline ]
    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.

  10. Catastrophizing thoughts related with pain [ Time Frame: Baseline ]
    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.

  11. Thoracic and lumbar curve [ Time Frame: Baseline ]
    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.

  12. Motor Control Impairment test: Active hip abduction test [ Time Frame: Baseline ]
    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.

  13. Motor Control Impairment test: Active straight leg raise test [ Time Frame: Baseline ]
    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.

  14. Motor Control Impairment test: Prone knee flexion test [ Time Frame: Baseline ]
    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.

  15. Endurance tests of the trunk muscles (McGill's protocol): Sorensen test [ Time Frame: Baseline ]

    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.


  16. Endurance tests of the trunk muscles (McGill's protocol): Abdominal endurance test [ Time Frame: Baseline ]

    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.


  17. Endurance tests of the trunk muscles (McGill's protocol): Side bridge test [ Time Frame: Baseline ]

    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.


  18. Endurance tests of the trunk and hip muscles: Supine Bridge Test [ Time Frame: Baseline ]

    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.


  19. Endurance tests of the hip muscles: Abductor Hip Endurance Test [ Time Frame: Baseline ]

    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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Office-based workers, defined as 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.
Criteria

Inclusion Criteria:

  • Office-based workers who perform more than 30 hours per week mostly sitting at a computer,
  • With aged 18 or above.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03678623


Contacts
Contact: Beatriz Rodriguez-Romero, PhD 00034 981167000 ext 5841 beatriz.romero@udc.es
Contact: Venerina Johnston, PhD +61 7 3346 4859 v.johnston@uq.edu.au

Locations
Australia, Queensland
The University of Queensland Recruiting
Brisbane, Queensland, Australia, 4072
Contact: Beatriz Rodriguez-Romero, PhD    0061 0451341972    b.rodriguezromero@uq.edu.au   
Sponsors and Collaborators
Universidade da Coruña
The University of Queensland
Investigators
Study Chair: Venerina Johnston, PhD The University of Queensland

Publications:

Responsible Party: Beatriz Rodríguez-Romero, Principal Investigator. PhD, MSc, PT. Lecturer at Faculty of Physiotherapy, Universidade da Coruña., Universidade da Coruña
ClinicalTrials.gov Identifier: NCT03678623     History of Changes
Other Study ID Numbers: Standing-musculoskeletal pain
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Beatriz Rodríguez-Romero, Universidade da Coruña:
Musculoskeletal Pain
Occupational Exposure
Predictive value of tests
Back muscles

Additional relevant MeSH terms:
Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms