NEXpro: Prevention and Intervention of Neck Pain in Swiss Office-Workers

Sponsor
Zurich University of Applied Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT04169646
Collaborator
Swiss National Science Foundation (Other)
120
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2
19.1
60
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Study Details

Study Description

Brief Summary

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, and 12 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 Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
This study is a stepped wedge cluster-randomized controlled trial.This study is a stepped wedge cluster-randomized controlled trial.
Masking:
Single (Outcomes Assessor)
Masking Description:
A senior bio-statistician blinded to the identity of individuals will randomise clusters to a sequence within the period of data collection when clusters change from the control to the intervention condition (group 1 to 3). The outcome assessors of the physical examination will be blinded to group allocation and previous test results of the participants.
Primary Purpose:
Prevention
Official Title:
On-site Multi-component Intervention to Improve Productivity and Reduce the Economic and Personal Burden of Neck Pain in Swiss Office-Workers
Actual Study Start Date :
Oct 28, 2019
Actual Primary Completion Date :
Jun 1, 2021
Actual Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Intervention

Multi-component intervention

Other: Multi-component intervention
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:
  • Workstation Ergonomics, Health promotion, Neck exercise, Adherence to intervention
  • Other: Control

    Control

    Other: Control
    No intervention takes place during the control phase.

    Outcome Measures

    Primary Outcome Measures

    1. NP-related productivity loss [baseline, after 4 months, after 8 months, after 12 months]

      NP-related productivity loss (economic outcome) will be measured in percentages of the working time, using the Work Productivity and Activity Impairment Questionnaire for Specific Health Problem (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.

    Secondary Outcome Measures

    1. Neck pain [baseline, after 4 months, after 8 months, after 12 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).

    2. Neck Disability Index [baseline, after 4 months, after 8 months, after 12 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)

    3. Physical activity level [baseline, after 4 months, after 8 months, after 12 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

    4. Health related Quality of life [baseline, after 4 months, after 8 months, after 12 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.

    5. Job-Stress-Index [baseline, after 4 months, after 8 months, after 12 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

    6. Health beliefs [baseline, after 4 months, after 8 months, after 12 months]

      Health beliefs will be assessed using three questions of the Fear-Avoidance Beliefs Questionnaire FABQ (dichotomous yes/no variable)

    7. Psychosocial workplace factors [baseline, after 4 months, after 8 months, after 12 months]

      Psychosocial workplace factors will be measured using a questionnaire (Copenhagen Psychosocial Questionnaire)

    8. Workplace ergonomics [baseline, after 4 months, after 8 months, after 12 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)

    9. Work implementation [baseline, after 4 months, after 8 months, after 12 months]

      a single question asking whether the participant felt their workplace culture supported the intervention (dichotomous yes/no variable).

    10. Adherence to intervention [after 4 months, after 8 months, after 12 months]

      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)

    11. Participants' impression of change [after 4 months, after 8 months, after 12 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).

    12. Care seeking [baseline, after 4 months, after 8 months, after 12 months]

      Evaluated by two questions: "Have you received healthcare services (e.g. doctor, physiotherapist, or other) because of work-related neck trouble in the past 12 months?" (yes/no; what) "Have you required pharmaceutical medications due to neck trouble or headache in the last week?" (yes/no; what)

    13. Breaks and Smartphone use [baseline, after 4 months, after 8 months, after 12 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)

    14. Job satisfaction [baseline, after 4 months, after 8 months, after 12 months]

      single item based on a 10-point numeric rating scale

    15. Movement control [baseline, after 4 months, after 8 months, after 12 months]

      Movement control dysfunction tests for the cervical spine (dichotomous, positive/negative)

    16. Mobility of neck and head [baseline, after 4 months, after 8 months, after 12 months]

      Mobility of the neck and head will be measured by an experienced and trained physiotherapist assessor using a CROM (range of motion, degree)

    17. Muscle endurance [baseline, after 4 months, after 8 months, after 12 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.

    18. Muscle strength [baseline, after 4 months, after 8 months, after 12 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.

    19. Pain pressure threshold [baseline, after 4 months, after 8 months, after 12 months]

      Pain pressure threshold of the upper cervical spine (occiput, atlas) and of the trapezius muscle will be determined by using an Algometer.

    20. Pain drawings [baseline, after 4 months, after 8 months, after 12 months]

      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).

    21. Headache [baseline, after 4 months, after 8 months, after 12 months]

      Headache will be measured using the questionnaire "headache impact test" (open questions and numeric pain rating scale ranging from 0 to 10).

    22. Pre-existing headache conditions [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)

    23. Demographic information [baseline, (after 4 months, after 8 months, after 12 months)]

      (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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kanton Aargau, Departement Bau, Verkehr und Umwelt Aarau Switzerland 5001
    2 ZHAW Winterthur Switzerland 8400

    Sponsors and Collaborators

    • Zurich University of Applied Sciences
    • Swiss National Science Foundation

    Investigators

    • Principal Investigator: Markus Melloh, Prof, ZHAW School of Health Professions

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Markus Melloh, Principal Investigator, Zurich University of Applied Sciences
    ClinicalTrials.gov Identifier:
    NCT04169646
    Other Study ID Numbers:
    • 32003B_182389
    First Posted:
    Nov 20, 2019
    Last Update Posted:
    Sep 9, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Markus Melloh, Principal Investigator, Zurich University of Applied Sciences
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 9, 2021