Prevention and Intervention of Neck Pain in Swiss Office-Workers

Neck Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04169646
• Other study ID #: 32003B_182389
• Status: Completed
• Phase: N/A
• Start date: October 28, 2019
• Est. completion date: July 31, 2022

Study information

• Verified date: March 2023
• Source: Zurich University of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Absenteeism
• Adherence, Patient
• Adult
• Efficiency
• Ergonomics
• Exercise Therapy
• Headache
• Health Promotion
• Musculoskeletal Diseases
• Neck Pain
• Occupational Health
• Presenteeism
• Surveys and Questionnaires
• Work Performance
• Workplace

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.
• Control
No intervention takes place during the control phase.

Locations

Country	Name	City	State
Switzerland	Kanton Aargau, Departement Bau, Verkehr und Umwelt	Aarau
Switzerland	ZHAW	Winterthur

Sponsors (2)

Lead Sponsor	Collaborator
Zurich University of Applied Sciences	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Other	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.	baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Other	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	baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Other	Health beliefs	Health beliefs will be assessed using three questions of the Fear-Avoidance Beliefs Questionnaire FABQ (dichotomous yes/no variable)	baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Other	Psychosocial workplace factors	Psychosocial workplace factors will be measured using a questionnaire (Copenhagen Psychosocial Questionnaire)	baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Other	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)	baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Other	Work implementation	a single question asking whether the participant felt their workplace culture supported the intervention (dichotomous yes/no variable).	baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Other	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)	after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Other	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).	after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Other	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)	baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Other	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)	baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Other	Job satisfaction	single item based on a 10-point numeric rating scale	baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Other	Movement control	Movement control dysfunction tests for the cervical spine (dichotomous, positive/negative)	baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Other	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)	baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Other	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.	baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Other	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.	baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Other	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.	baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Other	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).	baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Other	Headache	Headache will be measured using the questionnaire "headache impact test" (open questions and numeric pain rating scale ranging from 0 to 10).	baseline, after 4 months, after 8 months, after 12 months, after 16 months, after 28 months
Other	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)	baseline
Other	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)	baseline, (after 4 months, after 8 months, after 12 months, after 16 months, after 28 months)
Primary	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	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).	change from baseline at 16 months
Secondary	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)	change from baseline at 16 months