Clinical trial NCT04169646: Prevention and Intervention of Neck Pain in Swiss Office-Workers
Official title: On-site Multi-component Intervention to Improve Productivity and Reduce the Economic and Personal Burden of Neck Pain in Swiss Office-Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Headache
Musculoskeletal Diseases
Adherence, Patient
Absenteeism
Workplace
Health Promotion
Ergonomics
Efficiency
Presenteeism
Occupational Health
Surveys and Questionnaires
Adult
Exercise Therapy
Work Performance
Keywords: office-worker
neck-specific exercises
stepped wedge design
productivity
Lead sponsor: Zurich University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2019-11-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is a stepped wedge cluster-randomized controlled trial.
Primary purpose: PREVENTION

Brief summary: This study is the first that investigates the impact of a multi-component intervention combining current evidence of effective interventions with an adherence app to assess the potential benefits on productivity, neck pain, and headache.

Detailed description: Non-specific neck pain and headache are major economic and individual burdens in office-workers. The aim of this study is to investigate the effect of a multi-component intervention combining workstation ergonomics, health promotion information group workshops, neck exercises, and an app to enhance intervention adherence to assess possible reductions in the economic and individual burden of neck pain and headache in office workers.

This study is a stepped wedge cluster-randomized controlled trial. Eligible participants will be any office-worker aged 18-65 years from two Swiss organisations in the Canton of Zurich and Canton of Aargau, working more than 25 hours a week in predominantly sedentary office work and without serious health conditions of the neck. 120 voluntary participants will be assigned to 15 clusters which, at randomly selected time steps, switch from the control to the intervention group. The intervention will last 12 weeks and comprises workstation ergonomics, health promotion information group workshops, neck exercises and an adherence app. The primary outcome will be health-related productivity losses (presenteeism, absenteeism) using the Work Productivity and Activity Impairment Questionnaire. Secondary outcomes will include neck disability and pain. Physical and health outcomes (e.g. Neck Disability Index, muscle strength, and endurance), psychosocial outcomes (e.g. job-stress index, Fear-Avoidance Beliefs Questionnaire), workplace outcomes (e.g. workstation ergonomics), and individual outcomes (e.g. socio-demographic data, adherence to intervention) will be assessed. Measurements will take place at baseline, 4 months, 8 months, 12 months, 16 months, and 28 months after commencement. Data will be analysed on an 'intention to treat' basis and per protocol. Primary and secondary outcomes will be examined using linear mixed-effects models.

This study is the first that investigates the impact of a multi-component intervention combining current evidence of effective interventions with an adherence app to assess the potential benefits on productivity, neck pain, and headache. The outcomes will impact the individual, their workplace, as well as private and public policy by offering evidence for treatment and prevention of neck pain and headache in office-workers.

Eligibility criteria: Inclusion criteria:

* Swiss office-workers, who suffer from NP or want to take prevention of neck pain or headache
* 18-65 years old
* working more than 25 hours per week (0.6 full-time equivalent) in predominantly sedentary office work
* be able to communicate in German (written, spoken)
* have provided written informed consent

Exclusion criteria:

* previous trauma or injuries to the neck (NP grade 4)
* specific diagnosed pathologies (e.g., congenital cervical abnormalities, stenosis, fracture, radiculopathy)
* inflammatory condition (e.g., rheumatoid arthritis)
* any history of cervical spine surgery
* if exercise is contraindicated (e.g., medical advice, own beliefs)
* prolonged absence from work (more than four consecutive weeks) during the study intervention period
* pregnant women

Primary outcomes:
measure: Change in NP-related productivity loss
timeFrame: change from baseline at 16 months
Secondary outcomes:
measure: Neck pain
timeFrame: change from baseline at 16 months
measure: Neck Disability Index
timeFrame: change from baseline at 16 months
Other outcomes:
measure: Physical activity level
timeFrame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
measure: Health related Quality of life
timeFrame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
measure: Job-Stress-Index
timeFrame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
measure: Health beliefs
timeFrame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
measure: Psychosocial workplace factors
timeFrame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
measure: Workplace ergonomics
timeFrame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
measure: Work implementation
timeFrame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
measure: Adherence to intervention
timeFrame: after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
measure: Participants' impression of change
timeFrame: after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
measure: Care seeking
timeFrame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
measure: Breaks and Smartphone use
timeFrame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
measure: Job satisfaction
timeFrame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
measure: Movement control
timeFrame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
measure: Mobility of neck and head
timeFrame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
measure: Muscle endurance
timeFrame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
measure: Muscle strength
timeFrame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
measure: Pain pressure threshold
timeFrame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
measure: Pain drawings
timeFrame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
measure: Headache
timeFrame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
measure: Pre-existing headache conditions
timeFrame: baseline
measure: Demographic information
timeFrame: baseline, (after 4 months, after 8 months, after 12 months, after 16 months, after 28 months)
Locations:
city: Aarau
country: Switzerland
facility: Kanton Aargau, Departement Bau, Verkehr und Umwelt
city: Winterthur
country: Switzerland
facility: ZHAW
Study officials:
affiliation: ZHAW School of Health Professions
name: Markus Melloh, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aegerter AM, Deforth M, Volken T, Johnston V, Luomajoki H, Dressel H, Dratva J, Ernst MJ, Distler O, Brunner B, Sjogaard G, Melloh M, Elfering A; NEXpro Collaboration Group. A Multi-component Intervention (NEXpro) Reduces Neck Pain-Related Work Productivity Loss: A Randomized Controlled Trial Among Swiss Office Workers. J Occup Rehabil. 2023 Jun;33(2):288-300. doi: 10.1007/s10926-022-10069-0. Epub 2022 Sep 27.
citation: Aegerter AM, Deforth M, Johnston V, Sjogaard G, Volken T, Luomajoki H, Dratva J, Dressel H, Distler O, Elfering A, Melloh M; NEXpro collaboration group. No evidence for an effect of working from home on neck pain and neck disability among Swiss office workers: Short-term impact of COVID-19. Eur Spine J. 2021 Jun;30(6):1699-1707. doi: 10.1007/s00586-021-06829-w. Epub 2021 Apr 4.
citation: Aegerter AM, Deforth M, Sjogaard G, Johnston V, Volken T, Luomajoki H, Dratva J, Dressel H, Distler O, Melloh M, Elfering A; NEXpro Collaboration Group. No Evidence for a Decrease in Physical Activity Among Swiss Office Workers During COVID-19: A Longitudinal Study. Front Psychol. 2021 Feb 11;12:620307. doi: 10.3389/fpsyg.2021.620307. eCollection 2021.
citation: Aegerter AM, Deforth M, Johnston V, Ernst MJ, Volken T, Luomajoki H, Brunner B, Dratva J, Sjogaard G, Elfering A, Melloh M; NEXpro collaboration group. On-site multi-component intervention to improve productivity and reduce the economic and personal burden of neck pain in Swiss office-workers (NEXpro): protocol for a cluster-randomized controlled trial. BMC Musculoskelet Disord. 2020 Jun 19;21(1):391. doi: 10.1186/s12891-020-03388-x.