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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Exploring the Impact of Standing on the Musculoskeletal System of Sedentary-workers
Secondary ID [1] 0 0
Standing-musculoskeletal pain
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal Pain 0 0
Occupational Exposure 0 0
Office Workers 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Standing Tolerance Test (STT)
Timepoint [1] 0 0
Baseline
Secondary outcome [1] 0 0
Demographic characteristics:
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
Occupational characteristics: Occupational Sitting and Physical Activity Questionnaire (OSPAQ)
Timepoint [2] 0 0
Baseline
Secondary outcome [3] 0 0
Occupational characteristics: questions about using sit-stand workstation
Timepoint [3] 0 0
Baseline
Secondary outcome [4] 0 0
Occupational characteristics: Abbreviated Job Content Questionnaire (JCQ) & Job Satisfaction
Timepoint [4] 0 0
Baseline
Secondary outcome [5] 0 0
International Physical Activity Questionnaire (IPAQ)-Short Form
Timepoint [5] 0 0
Baseline
Secondary outcome [6] 0 0
Quality of life related to health: SF12 questionnaire
Timepoint [6] 0 0
Baseline
Secondary outcome [7] 0 0
Prevalence of musculoskeletal pain: Nordic Musculoskeletal Questionnaire (NMQ)
Timepoint [7] 0 0
Baseline
Secondary outcome [8] 0 0
Symptom intensity level of musculoskeletal pain: Visual Analogue Scale (VAS)
Timepoint [8] 0 0
Baseline
Secondary outcome [9] 0 0
Disability due to low back pain:
Timepoint [9] 0 0
Baseline
Secondary outcome [10] 0 0
Catastrophizing thoughts related with pain
Timepoint [10] 0 0
Baseline
Secondary outcome [11] 0 0
Thoracic and lumbar curve
Timepoint [11] 0 0
Baseline
Secondary outcome [12] 0 0
Motor Control Impairment test: Active hip abduction test
Timepoint [12] 0 0
Baseline
Secondary outcome [13] 0 0
Motor Control Impairment test: Active straight leg raise test
Timepoint [13] 0 0
Baseline
Secondary outcome [14] 0 0
Motor Control Impairment test: Prone knee flexion test
Timepoint [14] 0 0
Baseline
Secondary outcome [15] 0 0
Endurance tests of the trunk muscles (McGill's protocol): Sorensen test
Timepoint [15] 0 0
Baseline
Secondary outcome [16] 0 0
Endurance tests of the trunk muscles (McGill's protocol): Abdominal endurance test
Timepoint [16] 0 0
Baseline
Secondary outcome [17] 0 0
Endurance tests of the trunk muscles (McGill's protocol): Side bridge test
Timepoint [17] 0 0
Baseline
Secondary outcome [18] 0 0
Endurance tests of the trunk and hip muscles: Supine Bridge Test
Timepoint [18] 0 0
Baseline
Secondary outcome [19] 0 0
Endurance tests of the hip muscles: Abductor Hip Endurance Test
Timepoint [19] 0 0
Baseline

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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).

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2019
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
The University of Queensland - Brisbane
Recruitment postcode(s) [1] 0 0
4072 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
Universidade da Coruña
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of Queensland
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT03678623
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.
Public notes

Contacts
Principal investigator
Name 0 0
Venerina Johnston, PhD
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03678623