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

Primary Purpose

Neck Pain, Headache, Musculoskeletal Diseases

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Multi-component intervention
Control
Sponsored by
Zurich University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neck Pain focused on measuring office-worker, neck-specific exercises, stepped wedge design, productivity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kanton Aargau, Departement Bau, Verkehr und Umwelt
  • ZHAW

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Intervention

Control

Arm Description

Multi-component intervention

Control

Outcomes

Primary Outcome Measures

Change in NP-related productivity loss
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.

Secondary Outcome Measures

Neck pain
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).
Neck Disability Index
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)

Full Information

First Posted
November 13, 2019
Last Updated
March 21, 2023
Sponsor
Zurich University of Applied Sciences
Collaborators
Swiss National Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04169646
Brief Title
Prevention and Intervention of Neck Pain in Swiss Office-Workers
Acronym
NEXpro
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 28, 2019 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zurich University of Applied Sciences
Collaborators
Swiss National Science Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This study is a stepped wedge cluster-randomized controlled trial.
Masking
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.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Other
Arm Description
Multi-component intervention
Arm Title
Control
Arm Type
Other
Arm Description
Control
Intervention Type
Other
Intervention Name(s)
Multi-component intervention
Other Intervention Name(s)
Workstation Ergonomics, Health promotion, Neck exercise, Adherence to intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
No intervention takes place during the control phase.
Primary Outcome Measure Information:
Title
Change in NP-related productivity loss
Description
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.
Time Frame
change from baseline at 16 months
Secondary Outcome Measure Information:
Title
Neck pain
Description
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).
Time Frame
change from baseline at 16 months
Title
Neck Disability Index
Description
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)
Time Frame
change from baseline at 16 months
Other Pre-specified Outcome Measures:
Title
Physical activity level
Description
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
Time Frame
baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Title
Health related Quality of life
Description
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.
Time Frame
baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Title
Job-Stress-Index
Description
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
Time Frame
baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Title
Health beliefs
Description
Health beliefs will be assessed using three questions of the Fear-Avoidance Beliefs Questionnaire FABQ (dichotomous yes/no variable)
Time Frame
baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Title
Psychosocial workplace factors
Description
Psychosocial workplace factors will be measured using a questionnaire (Copenhagen Psychosocial Questionnaire)
Time Frame
baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Title
Workplace ergonomics
Description
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)
Time Frame
baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Title
Work implementation
Description
a single question asking whether the participant felt their workplace culture supported the intervention (dichotomous yes/no variable).
Time Frame
baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Title
Adherence to intervention
Description
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)
Time Frame
after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Title
Participants' impression of change
Description
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).
Time Frame
after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Title
Care seeking
Description
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)
Time Frame
baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Title
Breaks and Smartphone use
Description
three questions asking about the number of breaks during work, duration of each break (in minutes) and duration of daily smartphone use (in minutes)
Time Frame
baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Title
Job satisfaction
Description
single item based on a 10-point numeric rating scale
Time Frame
baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Title
Movement control
Description
Movement control dysfunction tests for the cervical spine (dichotomous, positive/negative)
Time Frame
baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Title
Mobility of neck and head
Description
Mobility of the neck and head will be measured by an experienced and trained physiotherapist assessor using a CROM (range of motion, degree)
Time Frame
baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Title
Muscle endurance
Description
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.
Time Frame
baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Title
Muscle strength
Description
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.
Time Frame
baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Title
Pain pressure threshold
Description
Pain pressure threshold of the upper cervical spine (occiput, atlas) and of the trapezius muscle will be determined by using an Algometer.
Time Frame
baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Title
Pain drawings
Description
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).
Time Frame
baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Title
Headache
Description
Headache will be measured using the questionnaire "headache impact test" (open questions and numeric pain rating scale ranging from 0 to 10).
Time Frame
baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Title
Pre-existing headache conditions
Description
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)
Time Frame
baseline
Title
Demographic information
Description
(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)
Time Frame
baseline, (after 4 months, after 8 months, after 12 months, after 16 months, after 28 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Melloh, Prof
Organizational Affiliation
ZHAW School of Health Professions
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kanton Aargau, Departement Bau, Verkehr und Umwelt
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
ZHAW
City
Winterthur
ZIP/Postal Code
8400
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).
IPD Sharing Time Frame
From June 2020 on (publication)
IPD Sharing Access Criteria
Open access
IPD Sharing URL
https://pubmed.ncbi.nlm.nih.gov/32560714/
Citations:
PubMed Identifier
36167936
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.
Results Reference
derived
PubMed Identifier
33817763
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.
Results Reference
derived
PubMed Identifier
33688857
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.
Results Reference
derived
PubMed Identifier
32560714
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. Erratum In: BMC Musculoskelet Disord. 2020 Jul 25;21(1):488. Dressler, Holger [corrected to Dressel, Holger].
Results Reference
derived

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Prevention and Intervention of Neck Pain in Swiss Office-Workers

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