An interventional study of Multi-component intervention and Control in Neck Pain, Headache and Musculoskeletal Diseases, sponsored by Zurich University of Applied Sciences. Completed at 2 sites in Switzerland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-22.
Sponsored by Zurich University of Applied Sciences · Not applicable, Interventional, and Prevention
Among 12 studies in Neck Pain with a site in Switzerland — 1 open to participants now, 1 under way, none of them phase 3. Neck Pain · Switzerland.
Among the 12 studies in Neck Pain with a site in Switzerland, this one is the only one that started in 2019, is one of 4 with no phase, and was the 9th registered.
1,360 studies on the registry are indexed under Neck Pain; 299 are open to participants now.
This study's enrollment of 120 is above the median of 50 across 1,116 interventional studies indexed under Neck Pain.
Browse Neck Pain studies →1 of the 12 studies in Neck Pain with a site in Switzerland is open now, in 1 country. Each count lists the studies.
Of the 155 Neck Pain studies recruiting now, 25 (16%) set no upper age limit and 117 (75%) stop at 75 or younger; 8 take children under 18; 26 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2019.
Median enrollment 120 across the 4 interventional studies, 70 across the 8 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.
None of the 12 has an industry lead sponsor. The 8 most frequent:
Zurich University of Applied Sciences is the lead sponsor of 23 studies on the registry; none are open to participants now.
Zurich University of Applied Sciences has 1 study filed under Neck Pain — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Neck Pain with a site in Switzerland, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Multi-component intervention
Other: Multi-component intervention
Control
Other: Control
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
No intervention takes place during the control phase.
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.
Time frame: change from baseline at 16 months
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).
Time frame: 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)
Time frame: change from baseline at 16 months
Physical activity level
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
Health related Quality of life
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
Job-Stress-Index
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
Health beliefs
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
Psychosocial workplace factors
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
Workplace ergonomics
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
Work implementation
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
Adherence to intervention
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
Participants' impression of change
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
Care seeking
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
Breaks and Smartphone use
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
Job satisfaction
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
Movement control
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
Mobility of neck and head
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
Muscle endurance
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
Muscle strength
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
Pain pressure threshold
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
Pain drawings
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
Headache
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
Pre-existing headache conditions
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
Demographic information
(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)
Plan to share: 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).
Supporting information: Study protocol
Time frame: From June 2020 on (publication)
Access criteria: Open access
Data sharing details ↗ · pubmed.ncbi.nlm.nih.gov
Ran from Oct 2019 to primary completion in Jul 2022, 33 months.
Of 763 non-industry interventional studies with no phase under Neck Pain, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's 33 months is above that.
Counting every sponsor, half of 772 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Zurich University of Applied Sciences