NCT04169646

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2019

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

2.8 years

First QC Date

November 13, 2019

Last Update Submit

March 21, 2023

Conditions

Keywords

office-workerneck-specific exercisesstepped wedge designproductivity

Outcome Measures

Primary Outcomes (1)

  • 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.

    change from baseline at 16 months

Secondary Outcomes (2)

  • Neck pain

    change from baseline at 16 months

  • Neck Disability Index

    change from baseline at 16 months

Other Outcomes (21)

  • Physical activity level

    baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months

  • Health related Quality of life

    baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months

  • Job-Stress-Index

    baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months

  • +18 more other outcomes

Study Arms (2)

Intervention

OTHER

Multi-component intervention

Other: Multi-component intervention

Control

OTHER

Control

Other: Control

Interventions

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.

Also known as: Workstation Ergonomics, Health promotion, Neck exercise, Adherence to intervention
Intervention
ControlOTHER

No intervention takes place during the control phase.

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Swiss office-workers, who suffer from NP or want to take prevention of neck pain or headache
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kanton Aargau, Departement Bau, Verkehr und Umwelt

Aarau, 5001, Switzerland

Location

ZHAW

Winterthur, 8400, Switzerland

Location

Related Publications (7)

  • Marchenko M, Domingues L, Barbero M, Cescon C, Falla D, Ernst MJ; NEXpro collaboration group. Headache, not neck pain, primarily influences the extent of pain in the neck region in symptomatic office workers. Cross-sectional and longitudinal evaluations. Physiother Theory Pract. 2025 Dec 12:1-11. doi: 10.1080/09593985.2025.2596179. Online ahead of print.

  • Ernst MJ, Meichtry A, Luedtke K; NEXpro collaboration group; Falla D. Effects of neck-exercise and health promotion on headache outcomes in office workers: secondary analysis of the NEXpro stepped wedge cluster randomised controlled trial. J Headache Pain. 2025 Feb 12;26(1):30. doi: 10.1186/s10194-025-01963-y.

  • Brunner B, Aegerter AM, Johnston V, Volken T, Deforth M, Sjogaard G, Elfering A, Melloh M; NEXpro Collaboration Group. Cost-utility and cost-benefit analysis of a multi-component intervention (NEXpro) for neck-related symptoms in Swiss office workers. BMC Public Health. 2025 Jan 15;25(1):160. doi: 10.1186/s12889-024-21103-6.

  • 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.

  • 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.

MeSH Terms

Conditions

Neck PainHeadacheMusculoskeletal DiseasesPatient Compliance

Interventions

Health Promotion

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Markus Melloh, Prof

    ZHAW School of Health Professions

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: This study is a stepped wedge cluster-randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 20, 2019

Study Start

October 28, 2019

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

March 22, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

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).

Shared Documents
STUDY PROTOCOL
Time Frame
From June 2020 on (publication)
Access Criteria
Open access
More information

Locations