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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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