- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04169646
Prevention and Intervention of Neck Pain in Swiss Office-Workers (NEXpro)
On-site Multi-component Intervention to Improve Productivity and Reduce the Economic and Personal Burden of Neck Pain in Swiss Office-Workers
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Aarau, Switzerland, 5001
- Kanton Aargau, Departement Bau, Verkehr und Umwelt
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Winterthur, Switzerland, 8400
- ZHAW
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Control
|
No intervention takes place during the control phase.
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Other: Intervention
Multi-component intervention
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Participants' workstation ergonomics will be assessed using an observation-based ergonomics assessment checklist for office-workers adapted to Swiss guidelines.
Based on the initial assessment, best practice ergonomics will be applied individually using existing infrastructure.
Participants will attend health promotion information group workshops for approximately one hour per week for 12 weeks.
it.
Participants will receive an individual progressive exercise programme aimed at conditioning the muscles of the neck and shoulder girdle.
The exercises will be performed in groups (maximum of ten per group) at the workplace in a dedicated room, for approximately one hour (3x20 minutes) per week; once per week supervised by a physiotherapist, a human movement scientist, or a health scientist, and twice per week individually.
Workshop session attendance will be recorded as an indication of adherence to health promotion.
Adherence to neck exercises will be recorded with the Physitrack® app.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in NP-related productivity loss
Time Frame: change from baseline at 16 months
|
Change in NP-related productivity loss will be measured in percentages of the working time, using the Work Productivity and Activity Impairment Questionnaire for Specific Health Problem (WPAI German version) and converted into monetary units using individual earnings.
Absenteeism is assessed by asking the participants about the number of hours missed because of NP as well as the number of hours they have actually worked.
To assess presenteeism, the participants are asked to indicate on a 10-score scale how much the NP affected productivity while working, with 0 indicating no effect on productivity and 10 indicating total disability.
Scoring rules of the developers of the questionnaire will then be used to obtain self-reported absenteeism and presenteeism expressed as impairment percentages.
The monetary value for the lost productivity will be obtained for each individual by multiplying the impairment percentages by the individual gross wage.
|
change from baseline at 16 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck pain
Time Frame: change from baseline at 16 months
|
Neck pain intensity, occurence and frequency will be measured based on existing questionnaires (Standardised Nordic questionnaires for the analysis of musculoskeletal Symptoms; Neuromuscular assessment in Elderly Workers with and without work related) (open questions and numeric pain rating scale ranging from 0 to 10). neck/shoulder trouble). |
change from baseline at 16 months
|
Neck Disability Index
Time Frame: change from baseline at 16 months
|
The German version of the Neck Disability Index (NDI) will be used to evaluate the extent to which NP interferes with vocational, recreational, social, and functional aspects of living.
(score from 0 to 100)
|
change from baseline at 16 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pre-existing headache conditions
Time Frame: baseline
|
Pre-existing headache conditions will be screened for by an adapted headache screening questionnaire, based on validated German questionnaires (German Language Questionnaire for Screening for Migraine, Tension-Type Headache, and Trigeminal Autonomic Cephalgias; German-Language Self-Administered Headache Questionnaire; Der Rostocker Kopfschmerzfragen-Komplex)
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baseline
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Physical activity level
Time Frame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
|
Short-form International Physical Activity Questionnaire (IPAQ German version) with data expressed as a continuous variable in metabolic equivalent of task (MET) min per week
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baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
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Health related Quality of life
Time Frame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
|
The EuroQoL Five Dimension (ordinal scale) and EuroQoL visual analogue scale VAS (0-100 representing worst to best imaginable health state, respectively) will be used.
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baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
|
Job-Stress-Index
Time Frame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
|
The Job-Stress-Index provides the ratio between resources and work stressors.
Normative statements (percentile ranks) will be given for representative groups of office-workers
|
baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
|
Health beliefs
Time Frame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
|
Health beliefs will be assessed using three questions of the Fear-Avoidance Beliefs Questionnaire FABQ (dichotomous yes/no variable)
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baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
|
Psychosocial workplace factors
Time Frame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
|
Psychosocial workplace factors will be measured using a questionnaire (Copenhagen Psychosocial Questionnaire)
|
baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
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Workplace ergonomics
Time Frame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
|
observation-based ergonomics assessment checklist for office workers is adapted according to Swiss guidelines and used to assess the workplace ergonomics (dichotomous yes/no variable; score)
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baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
|
Work implementation
Time Frame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
|
a single question asking whether the participant felt their workplace culture supported the intervention (dichotomous yes/no variable).
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baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
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Adherence to intervention
Time Frame: after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
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neck and shoulder exercise performance and health promotion session attendance are documented.
Next to this, participant's adherence to intervention (workplace ergonomics, exercises, health promotion) is asked using a self-reported scale (ordinal scale)
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after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
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Participants' impression of change
Time Frame: after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
|
patients' global impression of change scale (PGIC) is used to reflect the participant's belief about the efficacy of intervention (numeric rating scale ranging from 0 to 10).
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after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
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Care seeking
Time Frame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
|
Evaluated by two questions:
|
baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
|
Breaks and Smartphone use
Time Frame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
|
three questions asking about the number of breaks during work, duration of each break (in minutes) and duration of daily smartphone use (in minutes)
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baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
|
Job satisfaction
Time Frame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
|
single item based on a 10-point numeric rating scale
|
baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
|
Movement control
Time Frame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
|
Movement control dysfunction tests for the cervical spine (dichotomous, positive/negative)
|
baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
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Mobility of neck and head
Time Frame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
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Mobility of the neck and head will be measured by an experienced and trained physiotherapist assessor using a CROM (range of motion, degree)
|
baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
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Muscle endurance
Time Frame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
|
Muscle endurance (time in seconds to task failure) of neck extensor and flexor muscles will be measured in a standardized testing position, either lying prone for neck extensors or supine for testing neck flexor muscles.
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baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
|
Muscle strength
Time Frame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
|
Muscle strength of neck extensor and flexor muscles and shoulder abductor muscles, in Newton peak force will be standardized measured with three repetitions and by using a handheld Dynamometer.
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baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
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Pain pressure threshold
Time Frame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
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Pain pressure threshold of the upper cervical spine (occiput, atlas) and of the trapezius muscle will be determined by using an Algometer.
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baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
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Pain drawings
Time Frame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
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Pain drawings: participants will be asked to complete their pain profile during the last week on two body charts (frontal and dorsal views) by using a pen.
An operator will instruct the participants to shade their pain experience/complaints.
The pain profile will include the aspects of pain extent (expressed as the percentage of the total body chart area where the pain will be reported), pain locations, pain intensity (using a numeric pain rating scale ranging from 0 to 10), location of the most painful spot, and pain intensity of the most painful spot (using a numeric pain rating scale ranging from 0 to 10).
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baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
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Headache
Time Frame: baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
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Headache will be measured using the questionnaire "headache impact test" (open questions and numeric pain rating scale ranging from 0 to 10).
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baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
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Demographic information
Time Frame: baseline, (after 4 months, after 8 months, after 12 months, after 16 months, after 28 months)
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(self-reported) including employee's age (in years), sex, body-mass-index BMI (weight (kg) / height (m2)), duration of computer use/day (in minutes), occupation and income range (in CHF), working distance (in minutes, used transport system), general health conditions (diseases, nutrition, health literacy)
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baseline, (after 4 months, after 8 months, after 12 months, after 16 months, after 28 months)
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Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- 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. 2022 Sep 27:1-13. doi: 10.1007/s10926-022-10069-0. Online ahead of print.
- 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.
- 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.
- 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. Erratum In: BMC Musculoskelet Disord. 2020 Jul 25;21(1):488. Dressler, Holger [corrected to Dressel, Holger].
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 32003B_182389
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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