Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001176156
Ethics application status
Approved
Date submitted
2/08/2019
Date registered
20/08/2019
Date last updated
4/12/2019
Date data sharing statement initially provided
20/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Identifying optimal sit-stand recommendations for office workers with low back pain
Scientific title
Identifying optimal sit-stand recommendations for office workers with low back pain
Secondary ID [1] 298910 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 313888 0
Condition category
Condition code
Musculoskeletal 312303 312303 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Recommendation A (Arm 1)
Participants will receive one, face-to-face individual session at their workplace with a health professional (e.g. ergonomist or physiotherapist), where a fixed recommendation of alternate sitting and standing at a 2:1 ratio with 30 min of sitting and 15 min of standing will be prescribed. Written guidelines specific to this recommendation will be provided. The health professional will work with the participant to establish a suitable and acceptable method to ensure adherence to this schedule, which may include installing a mobile device app on their smartphone, a computer prompt, using an activity tracker with break alerts, or a timer. Preference will be given to free or already existing options. The health professional will contact participants individually fortnightly for 12 weeks via phone or email to provide support and troubleshoot concerns regarding adherence or discomfort.

Brief name: Recommendation B (Arm 2)
Participants will receive one, face-to-face individual session at their workplace with a health professional (e.g. ergonomist or physiotherapist), where a flexible recommendation of alternate sitting and standing will be prescribed. This personalised, ‘activity pacing’ approach will involve: (1) identifying how much a participant can engage in sitting and standing at a comfortable level, (2) developing an individual sit-stand ratio for that person (e.g. 75% of time to discomfort), and, (3) if desired, a plan for adjusting the ratio to a goal level of sitting and standing. Written guidelines specific to this recommendation will be provided. As per Recommendation A, a suitable and acceptable method to ensure adherence to this schedule will be established. The health professional will contact participants individually fortnightly for 12 weeks via phone or email to provide support and troubleshoot concerns regarding adherence or discomfort.
Intervention code [1] 315188 0
Treatment: Other
Intervention code [2] 315189 0
Behaviour
Comparator / control treatment
Arm 2 is the comparator group.
Control group
Active

Outcomes
Primary outcome [1] 320940 0
Low back pain assessed using an 11-point numerical pain rating scale (NPRS), with responses from 0 to 10 (‘no pain at all’ to ‘worst pain imaginable’).
Timepoint [1] 320940 0
Assessed daily for 1 week at baseline, 2 weeks and 3 months (primary timepoint) post intervention commencement
Secondary outcome [1] 373419 0
Accumulation pattern of sitting vs. standing – assessed using a thigh-worn activPAL monitor.
Timepoint [1] 373419 0
baseline, 2 weeks and 3 months post intervention commencement
Secondary outcome [2] 373423 0
Adherence to the sit-stand recommendation – assessed using a thigh-worn activPAL monitor and a self-report diary.
Timepoint [2] 373423 0
2 weeks and 3 months post intervention commencement
Secondary outcome [3] 373424 0
Frequency of recommendation adherence from ‘all of the time’ to ‘I did not follow the recommendation’, and reasons for the response – assessed by self-report study specific survey.
Timepoint [3] 373424 0
3 months post intervention commencement
Secondary outcome [4] 373425 0
Acceptability and satisfaction with allocated recommendations on a 5-point scale, from ‘very unacceptable/very dissatisfied’ to ‘very acceptable/very satisfied’ – assessed by self-report survey.
Timepoint [4] 373425 0
3 months post intervention commencement
Secondary outcome [5] 373426 0
Qualitative feedback will be collected from a sub-sample of participants after 3 months through semi-structured telephone interviews. Topics in the telephone interviews will cover acceptability of the recommendation, facilitators and barriers to implementing the recommendation, and whether the participant’s workplace environment (both physical and socio-cultural) or work tasks affected their use of the recommendation.
Timepoint [5] 373426 0
after 3 months post intervention commencement
Secondary outcome [6] 373427 0
Musculoskeletal pain in the last week in neck, upper back, lower back, shoulder, elbow, wrist/hand, hip/thigh, knee, and ankle/foot using an 11-point numerical pain rating scale (NPRS) from 0 to 10 (‘no pain at all’ to ‘worst pain imaginable’) – assessed by self-report survey.
Timepoint [6] 373427 0
baseline and 3 months post intervention commencement
Secondary outcome [7] 373428 0
Oswestry Disability Index – assessed by self-report survey.
Timepoint [7] 373428 0
baseline and 3 months post intervention commencement
Secondary outcome [8] 373429 0
Global Rating of Change Scale, to evaluate change in health – assessed by self-report survey.
Timepoint [8] 373429 0
3 months post intervention commencement
Secondary outcome [9] 373430 0
Global Rating of Change Scale, to evaluate change in low back pain – assessed by self-report survey.
Timepoint [9] 373430 0
3 months post intervention commencement
Secondary outcome [10] 373431 0
1 item on pain bothersomeness from the STarT Back Screening Tool – assessed by self-report survey.
Timepoint [10] 373431 0
baseline and 3 months post intervention commencement
Secondary outcome [11] 373432 0
Fear-Avoidance Belief Questionnaire, modified to be on sitting and standing behaviours – assessed by self-report survey.
Timepoint [11] 373432 0
baseline and 3 months post intervention commencement
Secondary outcome [12] 373433 0
Work Productivity and Activity Impairment Questionnaire – assessed by self-report survey.
Timepoint [12] 373433 0
baseline and 3 months post intervention commencement
Secondary outcome [13] 373434 0
Stanford Presenteeism Scale – assessed by self-report survey.
Timepoint [13] 373434 0
baseline and 3 months post intervention commencement
Secondary outcome [14] 373435 0
1 item on job performance from the World Health Organization Health and Work Performance Questionnaire – assessed by self-report survey.
Timepoint [14] 373435 0
baseline and 3 months post intervention commencement
Secondary outcome [15] 373764 0
1 item on job control from the Health and Work Questionnaire – assessed by self-report survey.
Timepoint [15] 373764 0
baseline and 3 months post intervention commencement
Secondary outcome [16] 373765 0
Work satisfaction subscale from the Health and Work Questionnaire – assessed by self-report survey.
Timepoint [16] 373765 0
baseline and 3 months post intervention commencement
Secondary outcome [17] 373766 0
Concentration subscale from the Health and Work Questionnaire – assessed by self-report survey.
Timepoint [17] 373766 0
baseline and 3 months post intervention commencement
Secondary outcome [18] 373767 0
1 item on stress from the Health and Work Questionnaire – assessed by self-report survey.
Timepoint [18] 373767 0
baseline and 3 months post intervention commencement
Secondary outcome [19] 373768 0
1 item on work-related stress (modified from Health and Work Questionnaire).
Timepoint [19] 373768 0
baseline and 3 months post intervention commencement
Secondary outcome [20] 373785 0
Strategies used to sit less and move more – assessed by self-report study specific survey.
Timepoint [20] 373785 0
baseline and 3 months post intervention commencement
Secondary outcome [21] 373786 0
Strategies used to manage pain and fatigue (7 items from the Activity Pacing Questionnaire) – assessed by self-report survey.
Timepoint [21] 373786 0
baseline and 3 months post intervention commencement
Secondary outcome [22] 373787 0
Intervention adverse events – assessed by self-report study specific survey.
Timepoint [22] 373787 0
3 months post intervention commencement

Eligibility
Key inclusion criteria
• Desk-based workers
• Currently have a sit-stand desk or workstation
• Work at least 3 days per week (or 0.6 full-time equivalent hours)
• Have experienced low back pain (LBP) within the previous one month. LBP will be classified as average pain of at least 2 out of 10 on an 11-point numerical pain rating scale with responses from 0 to 10 (‘no pain at all’ to ‘worst pain imaginable’).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Non-English speaking
• Have a known allergy to adhesive tape
• Have received medical advice to avoid standing for longer than 10 minutes at a time
• Have been diagnosed with circulation problems that limit standing
• Have arthritis in the hips and/or knees that limits standing up to 15 minutes at a time
• Have dizziness or regular loss of balance when standing
• Have had trauma or surgery to the back or legs in the past 12 months
• Experience pain if standing for up to 15 minutes at a time
• Are pregnant

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was off-site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation with randomly selected block sizes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: a 2-point change in lower back pain (LBP) is considered clinically meaningful. Assuming a standard deviation of 2.5 on a 0-10 scale (consistent with similar research in LBP), and a conservative pre-post correlation of 0.5, this study will require a sample of 30 per group to be powered at 80% to see a pre-post change in LBP of 2 points (accounting for 15% drop out). This sample size (n=60) will also enable detection of differences (baseline to 3 months) of 2 points of LBP between the two intervention groups (at 80% power).

Data analysis: statistical significance will be set at 5% (two-tailed). Analyses will be performed using STATA (version >=15). Changes in LBP from baseline to 3 months and differences between the intervention groups (A/B) will be assessed using a linear mixed model, to account for the repeated measures design. The analysis will adjust for baseline LBP, age, gender and other potential confounders (significant at p<0.2) and will use intention-to-treat principles (analysing by random assignment). Mixed models will also evaluate any changes in secondary outcomes, and determine if changes in sitting and standing are associated with changes in LBP. Qualitative data will be transcribed and coded for themes by two members of the research team, and triangulated with the survey acceptability items.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/09/2019
Actual
28/10/2019
Date of last participant enrolment
Anticipated
27/03/2020
Actual
Date of last data collection
Anticipated
31/07/2020
Actual
Sample size
Target
60
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 27391 0
4072 - University Of Queensland
Recruitment postcode(s) [2] 27392 0
4006 - Herston

Funding & Sponsors
Funding source category [1] 303459 0
Commercial sector/Industry
Name [1] 303459 0
Office Ergonomics Research Committee
Country [1] 303459 0
United States of America
Primary sponsor type
University
Name
RECOVER Injury Research Centre, The University of Queensland
Address
RECOVER Injury Research Centre
The University of Queensland
Herston Rd, Herston, QLD
Australia 4006
Country
Australia
Secondary sponsor category [1] 303512 0
None
Name [1] 303512 0
Address [1] 303512 0
Country [1] 303512 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303990 0
The University of Queensland Human Research Ethics Committee - B
Ethics committee address [1] 303990 0
Ethics committee country [1] 303990 0
Australia
Date submitted for ethics approval [1] 303990 0
28/05/2019
Approval date [1] 303990 0
30/08/2019
Ethics approval number [1] 303990 0
2019001270

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95470 0
Dr Charlotte Brakenridge
Address 95470 0
RECOVER Injury Research Centre
The University of Queensland
Herston Rd, Herston, QLD
Australia 4006
Country 95470 0
Australia
Phone 95470 0
+61 7 3346 4816
Fax 95470 0
Email 95470 0
[email protected]
Contact person for public queries
Name 95471 0
Charlotte Brakenridge
Address 95471 0
RECOVER Injury Research Centre
The University of Queensland
Herston Rd, Herston, QLD
Australia 4006
Country 95471 0
Australia
Phone 95471 0
+61 7 3346 4816
Fax 95471 0
Email 95471 0
[email protected]
Contact person for scientific queries
Name 95472 0
Charlotte Brakenridge
Address 95472 0
RECOVER Injury Research Centre
The University of Queensland
Herston Rd, Herston, QLD
Australia 4006
Country 95472 0
Australia
Phone 95472 0
+61 7 3346 4816
Fax 95472 0
Email 95472 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have ethical consent to share individual participant data publically.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.