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

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: Back Pain; Low Back Pain; Neck Pain
• Intervention / Treatment: Other: Exercise program

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

Study Locations

• Belgium
  • East Flanders
    • Ghent, East Flanders, Belgium, 9000
      • Recruiting
      • Ghent University
      • Contact: Vincent Dewitte, PhD; Phone Number: 0032 9 332 26 32; Email: Vincent.Dewitte@UGent.be
      • Contact: Email: Vincent.Dewitte@UGent.be
      • Principal Investigator: Vincent Dewitte, PhD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Did you develop neck pain (YES or NO)	1 year
low back pain	Did you develop low back pain (YES or NO)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
behavioral change	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)	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	amount of desktop work (hours/week)	1year
global perceived effect	What is your global perceived effect of the intervention program (NRS - score/100)	1year
use of (pain) medication and/or (para)medical care	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)	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)	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)	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

• Sponsor: University Ghent

Study record dates

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: primary prevention; sedentary work; desktop workers; telework; remote work
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Neck Pain
• 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