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Trial registered on ANZCTR


Registration number
ACTRN12612001154897
Ethics application status
Approved
Date submitted
29/10/2012
Date registered
31/10/2012
Date last updated
29/06/2021
Date data sharing statement initially provided
29/06/2021
Date results provided
29/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A workplace-based exercise intervention to prevent and reduce the economic and personal burden of non-specific neck pain in office personnel
Scientific title
A workplace-based exercise intervention to prevent and reduce the economic and personal burden of non-specific neck pain in office personnel aged 18-65 years.
Secondary ID [1] 281457 0
nil
Universal Trial Number (UTN)
U1111-1136-4579
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-specific neck pain 287720 0
Condition category
Condition code
Musculoskeletal 288055 288055 0 0
Other muscular and skeletal disorders
Public Health 288063 288063 0 0
Epidemiology
Physical Medicine / Rehabilitation 288064 288064 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Employees will receive an individualised best practice ergonomic assessment based on a comprehensive assessment conducted by a registered health professional. In addition, they will receive a progressive exercise program to condition the muscles of the neck/shoulder girdle supervised by a registered health professional. These exercises will be performed in the workplace for 20 minutes, three times per week for 12 weeks. A standard sequence of exercise will be prescribed to all employees but their implementation and progression will be within the specific capabilities of the individual. Employees will perform shoulder girdle exercises using dumbbells (single arm rows, bilateral shoulder shrugs, upright rows, reverse flyes, bilateral arm lateral arm raise to 90-degrees shoulder abduction) progressing from unresisted to resisted exercise utilising variable resistance bands. Training load for each individual will be based on their one-repetition maximum (1-RM) that will be regularly re-evaluated to ensure exercise is progressed accordingly. Each training session will commence with a warm up of ten repetitions at a load of 50% of 1-RM for each exercise. This will be followed by 2 to 3 sets of 10-15 repetitions of each exercise at 60-80% of their 1-RM. Progression of the exercises will be within the guidelines suggested for the principle of periodisation and progressive overload. Neck exercises (cervical flexion and extension exercises) that incorporate the coordinated function of the deep and superficial muscle layers will be included and progressed from unresisted to resisted exercise utilising variable resistance bands. Twelve weeks of this training schedule has been shown to be a sufficient intervention period to achieve significant adaptations.
Intervention code [1] 285958 0
Prevention
Intervention code [2] 285960 0
Lifestyle
Intervention code [3] 285971 0
Rehabilitation
Comparator / control treatment
Comparator/Control: Participants will receive an individualised best practice ergonomic intervention ONLY. As per the intervention arm the assessment will be conducted by a registered health professional. There are no anticipated adverse events or risks for the individual employee as it is standard practice for employees to receive ergonomic advice regarding their workstation and work practices. As the control arm will not recieve the exercise, intervention and to ensure parity in time with those in the intervention group, employees will be invited to attend health promotion sessions for one hour per week for 12 weeks. Topics will include information on healthy eating, stress management, weight loss, relaxation, cessation of smoking and safe drug and alcohol guidelines using resources provided by the Queensland Health Department.
Control group
Active

Outcomes
Primary outcome [1] 288262 0
Productivity Loss measured in monetary units calculated using the World Health Organisation Health and Productivity Questionnaire.
Timepoint [1] 288262 0
Baseline, immediate and 12 months post-intervention
Secondary outcome [1] 299710 0
Severity of Neck Pain measured using a 10-point scale ranging from 0 (no pain) to 9 (worst possible pain)
Timepoint [1] 299710 0
Baseline, immediate and 12 months post-intervention
Secondary outcome [2] 299711 0
The personal burden of Neck Pain will be measured using the 10-item Neck Disability Index.
Timepoint [2] 299711 0
Baseline, immediate and 12 months post-intervention
Secondary outcome [3] 299712 0
Muscle strength (Newtons) and endurance (time to task failure at 50% of maximal strength) of the neck and shoulder girdle will be evaluated using a portable digital dynamometer at the three time points.
Timepoint [3] 299712 0
Baseline, immediate and 12 months post-intervention
Secondary outcome [4] 299713 0
Health Related Quality of Life will be measured with the Assessment of Quality of Life Scale.
Timepoint [4] 299713 0
Baseline, immediate and 12 months post-intervention
Secondary outcome [5] 299714 0
Number of workers' compensation claims will be evaluated by one question: Have you received worker's compensation because of neck trouble in the past 12 months?"
Timepoint [5] 299714 0
baseline and 12 months post intervention
Secondary outcome [6] 299715 0
Psychosocial workplace factors will be evaluated using the Job Content Questionnaire.
Timepoint [6] 299715 0
baseline only
Secondary outcome [7] 299716 0
Job satisfaction will assessed with a single item: Overall how satisfied are you with your job?, scored on a seven point Likert scale where 1 was extremely dissatisfied and 7 was extremely satisfied.
Timepoint [7] 299716 0
baseline only
Secondary outcome [8] 299717 0
Physical activity levels will be measured using the valid and reliable short-form International Physical Activity Questionnaire (IPAQ) with data expressed as a continuous variable in MET-min per week
Timepoint [8] 299717 0
baseline only
Secondary outcome [9] 299718 0
Health beliefs will be assessed using three questions from the Fear-Avoidance Beliefs Questionnaire. Employees will be considered to hold fear-avoidance beliefs if they agree with the statements: Physical activity should be avoided when in pain and I should not do physical activities which (might) make my pain worse (dichotomous Yes/No variable).
Timepoint [9] 299718 0
baseline only

Eligibility
Key inclusion criteria
Eligible employees will be any office worker, aged 18-65 years, who work more than 30 hours/week in predominantly sedentary office work.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria are pregnancy, health conditions such as previous trauma or injuries to the neck, specific pathologies (e.g., congenital cervical abnormalities, stenosis) or inflammatory condition (e.g., rheumatoid arthritis), any history of cervical spine surgery or if exercise is contraindicated. Employees who anticipate any prolonged absence from work during the study's follow-up period will also be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An invitation to participate will be sent via the onsite liaison. Interested employees will be directed to a web-based questionnaire with information about the research, consent form, as well as questions to determine eligibility and their location to establish clusters. The project coordinator will determine eligibility for inclusion in the study and allocate eligible employees to a cluster (de-identified) until the required number is reached for each intake (6-8/year for 3 years). A cluster is defined as a group of 6 people located on the same floor, work group or building. Allocation will be based on clusters and allocation
concealment will be at the cluster level. A statistician who is based off-stie and blinded to the identity of the individuals will assign the clusters by simple random allocation (computer generated random number sequence) to either the control or intervention group. The project coordinator who will determine subject eligibility for inclusion in the trial will be unaware, when this decision was made, to which group the subject would be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician blinded to the identity of the individuals will assign clusters by simple random allocation to either the control or intervention group using computer generated random number sequence. A cluster is defined as a group of 6 people located on the same floor, work group or building.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The study design incorporates clusters where all workers in a work team or floor are randomised to the same intervention
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2013
Actual
27/05/2013
Date of last participant enrolment
Anticipated
Actual
26/06/2015
Date of last data collection
Anticipated
Actual
20/07/2016
Sample size
Target
640
Accrual to date
Final
763
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 286226 0
Government body
Name [1] 286226 0
National Health and Medical Research Council
Country [1] 286226 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
C/o Dr Susan O'Brien
Manager, Sponsored Research (Health and Biomedical Initiatives)
Research Management Office
UQ Research and Innovation
The University of Queensland
Brisbane Queensland 4072
Country
Australia
Secondary sponsor category [1] 285036 0
Government body
Name [1] 285036 0
National Health and Medical Research Council
Address [1] 285036 0
National Health and Medical Research Council
GPO Box 1421
Canberra City ACT 2601
Country [1] 285036 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288294 0
Medical Research Ethics Committee
Ethics committee address [1] 288294 0
Ethics committee country [1] 288294 0
Australia
Date submitted for ethics approval [1] 288294 0
19/11/2012
Approval date [1] 288294 0
24/01/2013
Ethics approval number [1] 288294 0
HREC number is 2012001318

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

Contacts
Principal investigator
Name 34887 0
Dr Dr Venerina Johnston
Address 34887 0
Level 7, Therapies Building 84A
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia 4072
Country 34887 0
Australia
Phone 34887 0
+ 61 7 33652124
Fax 34887 0
Email 34887 0
v.johnston@uq.edu.au
Contact person for public queries
Name 18134 0
Dr Venerina Johnston
Address 18134 0
Level 7, Therapies Building 84A
School of Health and Rehabilitation Sciences
The University of Queensland QLD 4072 Australia
Country 18134 0
Australia
Phone 18134 0
+61 7 3365 2124
Fax 18134 0
+61 7 3365 1622
Email 18134 0
v.johnston@uq.edu.au
Contact person for scientific queries
Name 9062 0
Dr Venerina Johnston
Address 9062 0
Level 7, Therapies Building 84A
School of Health and Rehabilitation Sciences
The University of Queensland QLD 4072 Australia
Country 9062 0
Australia
Phone 9062 0
+61 7 3365 2124
Fax 9062 0
+61 7 3365 1622
Email 9062 0
v.johnston@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseAn Investigation of Self-reported Health-related Productivity Loss in Office Workers and Associations with Individual and Work-related Factors Using an Employer's Perspective.2017https://dx.doi.org/10.1097/JOM.0000000000001043
EmbaseThe impact of workplace ergonomics and neck-specific exercise versus ergonomics and health promotion interventions on office worker productivity: A cluster-randomized trial.2019https://dx.doi.org/10.5271/sjweh.3760
EmbaseWorkplace-based exercise intervention improves work ability in office workers: A cluster randomised controlled trial.2019https://dx.doi.org/10.3390/ijerph16152633
EmbaseEvaluation of an exercise and ergonomics intervention for the prevention of neck pain in office workers: exploratory analysis of a cluster randomised trial.2022https://dx.doi.org/10.1136/oemed-2022-108275
N.B. These documents automatically identified may not have been verified by the study sponsor.