Neck PainPrevent@HOMENCT04783454
Preventing Neck & Back Pain in Teleworking Office Workers: a Randomized Controlled Trial
A study testing Exercise program in people with Neck Pain and Low Back Pain, run by University Ghent at 1 site in Belgium.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain, Low Back Pain, Back Pain
- What is being tested?
- Exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Nov 2020to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University
Ghent, East Flanders, 9000
Vincent Dewitte, PhD, 0032 9 332 26 32, Vincent.Dewitte@UGent.be
Vincent.Dewitte@UGent.be
About this study
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
Read the 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).
- Conditions
- Neck Pain, Low Back Pain, Back Pain
- Being tested
- Exercise program
- Keywords
- desktop workers, telework, remote work, sedentary work, primary prevention
- Medical subject headings
- Neck Pain, Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programOther
educational video on training program design and healthy lifestyle 24 training sessions (12 on cardiovascular endurance training, 12 on mobility and strength)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | * 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 Receives: Other: Exercise program |
| control | No intervention | no intervention (wait and see approach) |
What is being measured
The primary outcome is the main question the study is designed to answer.
neck pain
Did you develop neck pain (YES or NO)
Measured: 1 year
low back pain
Did you develop low back pain (YES or NO)
Measured: 1 year
Secondary outcomes (8)
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)
Measured: 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)
Measured: 1year
time to exposure
amount of desktop work (hours/week)
Measured: 1year
global perceived effect
What is your global perceived effect of the intervention program (NRS - score/100)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start12 Nov 2020
- Primary completion30 Nov 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783454
- Sponsor's protocol ID
- BC-08635
- Acronym
- Prevent@HOME
- Status last verified
- Nov 2023
- First submitted
- 26 Feb 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Neck & Back Pain in Teleworking Office Workers: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04783454
- Acronym / sponsor ID
- Prevent@HOME / BC-08635
- Conditions
- Neck Pain, Low Back Pain, Back Pain
- Keywords
- desktop workers, telework, remote work, sedentary work, primary prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Exercise program* 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 |
| control | No intervention | –no intervention (wait and see approach) |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise programeducational video on training program design and healthy lifestyle 24 training sessions (12 on cardiovascular endurance training, 12 on mobility and strength) | Other | Intervention |
Primary outcome
neck pain
Time frame: 1 year
Did you develop neck pain (YES or NO)
low back pain
Time frame: 1 year
Did you develop low back pain (YES or NO)
8 secondary outcomes
behavioral change
Time frame: 1 year
physical activity (Baecke Questionnaire)
Time frame: 1year
time to exposure
Time frame: 1year
global perceived effect
Time frame: 1year
use of (pain) medication and/or (para)medical care
Time frame: 1year
Depression Anxiety Stress Scale-21 (DASS-21 questionnaire)
Time frame: 1year
36-Item Short Form Health Survey (SF-36 questionnaire)
Time frame: 1year
Insomnia severity index (ISI questionnaire)
Time frame: 1year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program in people with Neck Pain and Low Back Pain, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neck pain (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.