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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Other trials in United States

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.

Conditions: Musculoskeletal Pain, Musculoskeletal Strain, Sedentary Lifestyle
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 groups in NCT03052426
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.

27 Feb 201727 Aug 2017

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)

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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy

All Musculoskeletal Pain trials

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
Conditions: Musculoskeletal Pain, Musculoskeletal Strain, Sedentary Lifestyle
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.

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

Results posted to the registry on 14 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
30 Minute Group	6	4
60 Minute Group	6	5
90 Minute Group	6	5

Primary outcome: Reported Musculoskeletal Discomfort Per Group at 3 Months

Time frame: 3 months. Mean (Standard Deviation). Unit: units on a scale

Measure	30 Minute Group n = 6	60 Minute Group n = 6	90 Minute Group n = 4
Aches and Pains	1.43 (0.38)	1.33 (0.12)	1.47 (0.40)
Uncomfortable from Aches	0.46 (0.40)	0.54 (0.40)	0.89 (0.93)
Interference	0.50 (0.20)	0.50 (0.20)	0.65 (0.24)

30 Minute Group vs 60 Minute Group vs 90 Minute Group: p = 0.9327, Chi-squared
30 Minute Group vs 60 Minute Group vs 90 Minute Group: p = 0.7523, Chi-squared
30 Minute Group vs 60 Minute Group vs 90 Minute Group: p = 0.9196, Chi-squared

Population analysed: At this point in the study there were still 16 individuals enrolled.

Primary outcome: Reported Musculoskeletal Discomfort Per Group at 6 Months

Time frame: 6 months. Mean (Standard Deviation). Unit: units on a scale

Measure	30 Minute Group n = 4	60 Minute Group n = 5	90 Minute Group n = 5
Aches and Pains	1.56 (0.53)	1.31 (0.27)	1.53 (0.37)
Uncomfortable from Aches	0.64 (0.62)	0.30 (0.23)	0.80 (0.47)
Interfere with Work	0.47 (0.43)	0.33 (0.31)	0.62 (0.37)

30 Minute Group vs 60 Minute Group vs 90 Minute Group: p = 0.6316, Chi-squared
30 Minute Group vs 60 Minute Group vs 90 Minute Group: p = 0.2595, Chi-squared
30 Minute Group vs 60 Minute Group vs 90 Minute Group: p = 0.4495, Chi-squared

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
30 Minute Group	0 of 6 (0%)	0 of 6 (0%)	0 of 6
60 Minute Group	0 of 6 (0%)	0 of 6 (0%)	0 of 6
90 Minute Group	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Limitations and caveats (from the sponsor): Number of participants per group were small creating decreased power for study results between groups.

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.

Related trials for Musculoskeletal Pain

Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy

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?

On the ClinicalTrials.gov record for NCT03052426.

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.