Neck PainNEXproNCT04169646
Prevention and Intervention of Neck Pain in Swiss Office-Workers
A study testing Multi-component intervention in people with Neck Pain and Headache, run by Zurich University of Applied Sciences at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain, Headache, Musculoskeletal Diseases
- What is being tested?
- Multi-component intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 28 Oct 2019to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Kanton Aargau, Departement Bau, Verkehr und Umwelt
Aarau, 5001
ZHAW
Winterthur, 8400
About this study
Official title: On-site Multi-component Intervention to Improve Productivity and Reduce the Economic and Personal Burden of Neck Pain in Swiss Office-Workers
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.
Read the 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.
- Conditions
- Neck Pain, Headache, Musculoskeletal Diseases, Adherence, Patient, Absenteeism, Workplace
- Being tested
- Multi-component intervention, Control
- Keywords
- office-worker, neck-specific exercises, stepped wedge design, productivity
- Medical subject headings
- Neck Pain, Headache, Musculoskeletal Diseases, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-component interventionOther
Also called Workstation Ergonomics, Health promotion, Neck exercise, Adherence to 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.
ControlOther
No intervention takes place during the control phase.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Multi-component intervention Receives: Other: Multi-component intervention |
| Control | Other | Control Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline at 16 months
Secondary outcomes (2)
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).
Measured: change from baseline at 16 months
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)
Measured: change from baseline at 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start28 Oct 2019
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is a stepped wedge cluster-randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zurich University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Principal investigator, Markus Melloh, Zurich University of Applied Sciences
- Investigators
- Markus Melloh, Prof, Principal investigator, ZHAW School of Health Professions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169646
- Sponsor's protocol ID
- 32003B_182389
- Acronym
- NEXpro
- Status last verified
- Mar 2023
- First submitted
- 13 Nov 2019
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
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. 2026 May;42(5):689-699. doi: 10.1080/09593985.2025.2596179. Epub 2025 Dec 12.
PubMed 41384674Ernst 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.
PubMed 39939850Brunner 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.
PubMed 39815202Aegerter 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.
PubMed 36167936Aegerter 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.
PubMed 33817763Aegerter 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.
PubMed 33688857Aegerter 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.
PubMed 32560714
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On-site Multi-component Intervention to Improve Productivity and Reduce the Economic and Personal Burden of Neck Pain in Swiss Office-Workers
- ClinicalTrials.gov ID
- NCT04169646
- Acronym / sponsor ID
- NEXpro / 32003B_182389
- Conditions
- Neck Pain, Headache, Musculoskeletal Diseases, Adherence, Patient, Absenteeism, Workplace
- Keywords
- office-worker, neck-specific exercises, stepped wedge design, productivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Zurich University of Applied SciencesUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a stepped wedge cluster-randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Multi-component interventionMulti-component intervention |
| Control | Other | Other: ControlControl |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-component interventionAlso: Workstation Ergonomics, Health promotion, Neck exercise, Adherence to interventionParticipants' 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 | Intervention |
| ControlNo intervention takes place during the control phase. | Other | Control |
Primary outcome
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.
2 secondary outcomes
Neck pain
Time frame: change from baseline at 16 months
Neck Disability Index
Time frame: change from baseline at 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Derived from this study: PubMed 41384674Marchenko 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. 2026 May;42(5):689-699. doi: 10.1080/09593985.2025.2596179. Epub 2025 Dec 12.
- Derived from this study: PubMed 39939850Ernst 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.
- Derived from this study: PubMed 39815202Brunner 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.
- Derived from this study: PubMed 36167936Aegerter 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.
- Derived from this study: PubMed 33817763Aegerter 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.
- Derived from this study: PubMed 33688857Aegerter 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.
- Derived from this study: PubMed 32560714Aegerter 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Melloh, Prof principal investigator
ZHAW School of Health Professions
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-component intervention in people with Neck Pain and Headache, run by Zurich University of Applied Sciences at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NP-related productivity loss (time frame: change from baseline at 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04169646, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.