Preventing Neck & Back Pain in Teleworking Office Workers: a Randomized Controlled Trial (Prevent@HOME)

November 15, 2023 updated by: University Ghent
The purpose of this study is to assess the effect of a general training program and educational session to prevent neck and/or low back pain in desktop workers

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

After being informed about the study and potential risks, all subjects that met the preset inclusion criteria and gave written informed consent to participate will be randomized into an intervention or control group in a 1:1 ratio. Next, subjects of both groups will undergo baseline testing (online survey). The subjects of the intervention group receive a single educational video (online) and are motivated to follow 2 training sessions of 60 minutes each, during 12 consecutive weeks. Instructions for the specific exercises are provided via an online platform. The subjects of the control group are instructed to maintain their normal working activities and activities of daily life and receive no further intervention. Subjects of both groups are prompted to fill out a weekly online logbook to gather information on their physical activity and neck and/or back complaints. All subjects undergo post-intervention testing at 12 weeks (short term effects), 6 months, and 12 months (long term effects).

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  • age between 18-69 years
  • perform regular desktop work (at least 20 hours/week)
  • perform desktop work for at least 1 year (employee or student)

Exclusion Criteria:

  • documented structural neck- and/or back pathology (confirmed by medical imaging)
  • known shoulder or vestibular pathology
  • whiplash-associated disorders
  • history of surgery in the neck, shoulder, hip, and/or back area
  • (history of) chronic pain condition
  • serious headache
  • serious cardiovascular/metabolic/systemic/neurological conditions
  • chronic fatigue syndrome
  • fibromyalgia
  • psychiatric conditions or history of serious depression
  • serious catastrophizing thoughts
  • pregnancy or delivery in the past year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
  • single (online) educational video on how the prevention program is designed and general advice on (how to adopt) a healthy lifestyle
  • 12-week training program: 2 sessions of 60 minutes per week, with the focus of the first session on cardiovascular exercises, and the focus of the second session on mobility and strengthening exercises
Other: Exercise program
educational video on training program design and healthy lifestyle 24 training sessions (12 on cardiovascular endurance training, 12 on mobility and strength)
No Intervention: control
no intervention (wait and see approach)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neck pain
Time Frame: 1 year
Did you develop neck pain (YES or NO)
1 year
low back pain
Time Frame: 1 year
Did you develop low back pain (YES or NO)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
behavioral change
Time Frame: 1 year
Tendency to remain physically active (PA) during working hours as compared to before your participation in this study (Likert-type scale: not at all PA - slightly less PA - equally PA - slightly more PA - clearly more PA)
1 year
physical activity (Baecke Questionnaire)
Time Frame: 1year
physical activity measurement (activities are scored on a scale of 1-5 with the total scored from 3-15. the lower the score, the less physically active)
1year
time to exposure
Time Frame: 1year
amount of desktop work (hours/week)
1year
global perceived effect
Time Frame: 1year
What is your global perceived effect of the intervention program (NRS - score/100)
1year
use of (pain) medication and/or (para)medical care
Time Frame: 1year
use of (pain) medication and/or (para)medical care (name, dosage/frequency, effect, prescribed or direct acces)
1year
Depression Anxiety Stress Scale-21 (DASS-21 questionnaire)
Time Frame: 1year
fear, depressive mood, and stress due to COVID-19 crisis and confinement (21 items, Each item is scored from 0 to 3 and is doubled so the global ISI score ranges from 0 to 42)
1year
36-Item Short Form Health Survey (SF-36 questionnaire)
Time Frame: 1year
quality of life during confinement and telework (item scores are summed to scale scores and transformed into a hundred point scale; scores are transformed so that a higher score indicates better health status)
1year
Insomnia severity index (ISI questionnaire)
Time Frame: 1year
quality of sleep during confinement and telework (7 items, Each item is scored from 0 to 4 and the global ISI score ranges from 0 to 28)
1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2020

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

March 2, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC-08635

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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