Musculoskeletal PainNCT03052426
Occupational Therapy's Role in Promoting Community Wellness Utilizing Sit-Stand Workstations
A study testing Ergotron WorkFit - TL in people with Musculoskeletal Pain and Musculoskeletal Strain, run by West Virginia University at 1 site in United States.
Trial summary
The aim of this study is to combat the growing global health issue of sedentary behavior and the associated health consequences of prolonged sitting in the workplace. The population of desk-based workers makes up a relatively large population and are an important target for this health promoting initiative with a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain, Musculoskeletal Strain, Sedentary Lifestyle
- What is being tested?
- Ergotron WorkFit - TL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2017to 27 Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must spend > 50% of their work day seated at the computer
- Participants must be primarily English speaking
- Participants must work within the Health Sciences Center building at West Virginia University
Who cannot join
- Participants who are less than 18 years of age
- Participants who are not primarily English speaking
- Participants who spend <50% of their work day seated at the computer
- Participants who do not work within the Health Sciences Center building at West Virginia University
- Participants who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University
Morgantown, West Virginia, 26506
About this study
Official title: Occupational Therapy's Role in Promoting Community Wellness: A Multi-modal Approach to Combat Sedentary Behavior in the Workplace Utilizing Sit-Stand Workstations
The aim of this study is to combat the growing global health issue of sedentary behavior and the associated health consequences of prolonged sitting in the workplace. The population of desk-based workers makes up a relatively large population and are an important target for this health promoting initiative with a focus on improving posture, encouraging movement, and fostering a more active and healthy business community. It's important to recognize that occupational therapy practitioners can contribute to community health promotion/disease prevention programs by the skill-set of practitioners to understand habits and routines that influence the adoption and maintenance of healthy behaviors.
- Being tested
- Ergotron WorkFit - TL
- Medical subject headings
- Musculoskeletal Pain, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergotron WorkFit - TLDevice
A sit to stand work station.
| Study group | Role | What they receive |
|---|---|---|
| 30 Minute Group | Active comparator | This group will use the Ergotron WorkFit-TL (a sit to stand work station) and be required to alternate periods of sitting and standing every 30 minutes throughout their workday. Receives: Device: Ergotron WorkFit - TL |
| 60 Minute Group | Active comparator | This group will use the Ergotron WorkFit-TL (a sit to stand work station) and be required to alternate periods of sitting and standing every 60 minutes throughout their workday. Receives: Device: Ergotron WorkFit - TL |
| 90 Minute Group | Active comparator | This group will use the Ergotron WorkFit-TL (a sit to stand work station) and be required to alternate periods of sitting and standing every 90 minutes throughout their workday. Receives: Device: Ergotron WorkFit - TL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reported Musculoskeletal Discomfort Per Group at 3 Months
Three scales were compiled 1) aches and pains, 2) discomfort and 3) interference due to aches and pains. All three scales included 9 questions centered on the occurrence in body regions, including the neck, shoulder, upper and lower back, upper arms, forearm/wrist, hip, thigh, and knee/lower leg. Aches and Pains was on a 5 point scale, from 1) Never to 5) Several Times a Day. Uncomfortable was on a 4 point scale, ranging from 0) No Discomfort to 3) Very Uncomfortable. Interference was on a 4 point scale from 0) Not a problem to 3) Substantially interfered. Higher scores indicated more problems in each of these areas.
Measured: 3 months
Reported Musculoskeletal Discomfort Per Group at 6 Months
Three scales were compiled 1) aches and pains, 2) discomfort and 3) interference due to aches and pains. All three scales included 9 questions centered on the occurrence in body regions, including the neck, shoulder, upper and lower back, upper arms, forearm/wrist, hip, thigh, and knee/lower leg. Aches and Pains was on a 5 point scale, from 1) Never to 5) Several Times a Day. Uncomfortable was on a 4 point scale, ranging from 0) No Discomfort to 3) Very Uncomfortable. Interference was on a 4 point scale from 0) Not a problem to 3) Substantially interfered. Higher scores indicated more problems in each of these areas.
Measured: 6 months
Secondary outcomes (1)
Reported Musculoskeletal Discomfort at Work at 3 Months and 6 Months All Groups Combined
The Cornell Musculoskeletal Discomfort Questionnaire consists of three scales that were compiled 1) aches and pains, 2) discomfort and 3) interference due to aches and pains. All three scales included 9 questions centered on the occurrence in body regions, including the neck, shoulder, upper and lower back, upper arms, forearm/wrist, hip, thigh, and knee/lower leg. Aches and Pains was on a 5 point scale, from 1) Never to 5) Several Times a Day. Uncomfortable was on a 4 point scale, ranging from 0) No Discomfort to 3) Very Uncomfortable. Interference was on a 4 point scale from 0) Not a problem to 3) Substantially interfered. Higher scores indicated more problems in each of these areas.
Measured: Beginning of study, 3 months, and 6 months (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start27 Feb 2017
- Primary completion27 Aug 2017
- Study completion27 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe 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
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brandy Brown, West Virginia University
- Investigators
- Brandy Brown, OTD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052426
- Sponsor's protocol ID
- 1612397536
- Status last verified
- Jan 2019
- First submitted
- 8 Feb 2017
- Last updated
- 14 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is not a plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Therapy's Role in Promoting Community Wellness: A Multi-modal Approach to Combat Sedentary Behavior in the Workplace Utilizing Sit-Stand Workstations
- ClinicalTrials.gov ID
- NCT03052426
- Acronym / sponsor ID
- 1612397536
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 27 Aug 2017 (actual)
- Study completion
- 27 Aug 2017 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Posted 14 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to combat the growing global health issue of sedentary behavior and the associated health consequences of prolonged sitting in the workplace. The population of desk-based workers makes up a relatively large population and are an important target for this health promoting initiative with a focus on improving posture, encouraging movement, and fostering a more active and healthy business community. It's important to recognize that occupational therapy practitioners can contribute to community health promotion/disease prevention programs by the skill-set of practitioners to understand habits and routines that influence the adoption and maintenance of healthy behaviors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 30 Minute Group | Active comparator | Device: Ergotron WorkFit - TLThis group will use the Ergotron WorkFit-TL (a sit to stand work station) and be required to alternate periods of sitting and standing every 30 minutes throughout their workday. |
| 60 Minute Group | Active comparator | Device: Ergotron WorkFit - TLThis group will use the Ergotron WorkFit-TL (a sit to stand work station) and be required to alternate periods of sitting and standing every 60 minutes throughout their workday. |
| 90 Minute Group | Active comparator | Device: Ergotron WorkFit - TLThis group will use the Ergotron WorkFit-TL (a sit to stand work station) and be required to alternate periods of sitting and standing every 90 minutes throughout their workday. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must spend > 50% of their work day seated at the computer
- Participants must be primarily English speaking
- Participants must work within the Health Sciences Center building at West Virginia University
Key exclusion criteria (5 listed)
- Participants who are less than 18 years of age
- Participants who are not primarily English speaking
- Participants who spend <50% of their work day seated at the computer
- Participants who do not work within the Health Sciences Center building at West Virginia University
- Participants who are pregnant
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 |
|---|---|---|
| Ergotron WorkFit - TLA sit to stand work station. | Device | 30 Minute Group, 60 Minute Group, 90 Minute Group |
Primary outcome
Reported Musculoskeletal Discomfort Per Group at 3 Months
Time frame: 3 months
Three scales were compiled 1) aches and pains, 2) discomfort and 3) interference due to aches and pains. All three scales included 9 questions centered on the occurrence in body regions, including the neck, shoulder, upper and lower back, upper arms, forearm/wrist, hip, thigh, and knee/lower leg. Aches and Pains was on a 5 point scale, from 1) Never to 5) Several Times a Day. Uncomfortable was on a 4 point scale, ranging from 0) No Discomfort to 3) Very Uncomfortable. Interference was on a 4 point scale from 0) Not a problem to 3) Substantially interfered. Higher scores indicated more problems in each of these areas.
Reported Musculoskeletal Discomfort Per Group at 6 Months
Time frame: 6 months
Three scales were compiled 1) aches and pains, 2) discomfort and 3) interference due to aches and pains. All three scales included 9 questions centered on the occurrence in body regions, including the neck, shoulder, upper and lower back, upper arms, forearm/wrist, hip, thigh, and knee/lower leg. Aches and Pains was on a 5 point scale, from 1) Never to 5) Several Times a Day. Uncomfortable was on a 4 point scale, ranging from 0) No Discomfort to 3) Very Uncomfortable. Interference was on a 4 point scale from 0) Not a problem to 3) Substantially interfered. Higher scores indicated more problems in each of these areas.
1 secondary outcome
Reported Musculoskeletal Discomfort at Work at 3 Months and 6 Months All Groups Combined
Time frame: Beginning of study, 3 months, and 6 months (end of study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is not a plan to share individual participant data.
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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. This study is not recruiting at the moment.
Brandy Brown, OTD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergotron WorkFit - TL in people with Musculoskeletal Pain and Musculoskeletal Strain, run by West Virginia University at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 14 Jan 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 14 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reported Musculoskeletal Discomfort Per Group at 3 Months (time frame: 3 months). 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 14 Jan 2019.