Preventing Neck & Back Pain in Teleworking Office Workers: a Randomized Controlled Trial (Prevent@HOME)
Primary Purpose
Neck Pain, Low Back Pain, Back Pain
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Exercise program
Sponsored by
About this trial
This is an interventional prevention trial for Neck Pain focused on measuring desktop workers, telework, remote work, sedentary work, primary prevention
Eligibility Criteria
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
Sites / Locations
- Ghent UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
control
Arm Description
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
no intervention (wait and see approach)
Outcomes
Primary Outcome Measures
neck pain
Did you develop neck pain (YES or NO)
low back pain
Did you develop low back pain (YES or NO)
Secondary Outcome Measures
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)
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)
time to exposure
amount of desktop work (hours/week)
global perceived effect
What is your global perceived effect of the intervention program (NRS - score/100)
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)
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)
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04783454
Brief Title
Preventing Neck & Back Pain in Teleworking Office Workers: a Randomized Controlled Trial
Acronym
Prevent@HOME
Official Title
Preventing Neck & Back Pain in Teleworking Office Workers: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2020 (Actual)
Primary Completion Date
November 30, 2028 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Low Back Pain, Back Pain
Keywords
desktop workers, telework, remote work, sedentary work, primary prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
All investigators and outcome assessors are blind to the subjects' allocation
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
control
Arm Type
No Intervention
Arm Description
no intervention (wait and see approach)
Intervention Type
Other
Intervention Name(s)
Exercise program
Intervention Description
educational video on training program design and healthy lifestyle 24 training sessions (12 on cardiovascular endurance training, 12 on mobility and strength)
Primary Outcome Measure Information:
Title
neck pain
Description
Did you develop neck pain (YES or NO)
Time Frame
1 year
Title
low back pain
Description
Did you develop low back pain (YES or NO)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
behavioral change
Description
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)
Time Frame
1 year
Title
physical activity (Baecke Questionnaire)
Description
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)
Time Frame
1year
Title
time to exposure
Description
amount of desktop work (hours/week)
Time Frame
1year
Title
global perceived effect
Description
What is your global perceived effect of the intervention program (NRS - score/100)
Time Frame
1year
Title
use of (pain) medication and/or (para)medical care
Description
use of (pain) medication and/or (para)medical care (name, dosage/frequency, effect, prescribed or direct acces)
Time Frame
1year
Title
Depression Anxiety Stress Scale-21 (DASS-21 questionnaire)
Description
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)
Time Frame
1year
Title
36-Item Short Form Health Survey (SF-36 questionnaire)
Description
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)
Time Frame
1year
Title
Insomnia severity index (ISI questionnaire)
Description
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)
Time Frame
1year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ghent University
City
Ghent
State/Province
East Flanders
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Dewitte, PhD
Phone
0032 9 332 26 32
Email
Vincent.Dewitte@UGent.be
Email
Vincent.Dewitte@UGent.be
First Name & Middle Initial & Last Name & Degree
Vincent Dewitte, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Preventing Neck & Back Pain in Teleworking Office Workers: a Randomized Controlled Trial
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