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

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ClinicalTrials.gov Identifier: NCT04169646
Recruitment Status : Active, not recruiting
First Posted : November 20, 2019
Last Update Posted : April 21, 2021
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
Markus Melloh, Zurich University of Applied Sciences

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.


Condition or disease Intervention/treatment Phase
Neck Pain Headache Musculoskeletal Diseases Adherence, Patient Absenteeism Workplace Health Promotion Ergonomics Efficiency Presenteeism Occupational Health Surveys and Questionnaires Adult Exercise Therapy Work Performance Other: Multi-component intervention Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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 : October 28, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Workstation Ergonomics, Health promotion, Neck exercise, Adherence to intervention

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




Primary Outcome Measures :
  1. NP-related productivity loss [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: baseline, after 4 months, after 8 months, after 12 months ]
    single item based on a 10-point numeric rating scale

  15. Movement control [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ 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)

  23. Demographic information [ Time Frame: 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04169646


Locations
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Switzerland
Kanton Aargau, Departement Bau, Verkehr und Umwelt
Aarau, Switzerland, 5001
ZHAW
Winterthur, Switzerland, 8400
Sponsors and Collaborators
Zurich University of Applied Sciences
Swiss National Science Foundation
Investigators
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Principal Investigator: Markus Melloh, Prof ZHAW School of Health Professions
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Markus Melloh, Principal Investigator, Zurich University of Applied Sciences
ClinicalTrials.gov Identifier: NCT04169646    
Other Study ID Numbers: 32003B_182389
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: After the statistical analysis of this trial, the NEXpro team will make every endeavour to publish data in a journal (e.g. medical, health sciences). In particular, the following publications are planned: study protocol, primary outcome (productivity analysis), and several studies on the secondary and additional outcomes (e.g. neck pain analysis).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Markus Melloh, Zurich University of Applied Sciences:
office-worker
neck-specific exercises
stepped wedge design
productivity
Additional relevant MeSH terms:
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Musculoskeletal Diseases
Headache
Neck Pain
Pain
Neurologic Manifestations