Low Back PainNCT02146482

Access to a Sit-stand Computer Workstation and Back Pain

A study testing Sit-stand computer workstation in people with Low Back Pain and Back Pain, run by Stanford 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

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Trial summary

The purpose of the study is to evaluate the changes in back pain from access to a sit-stand workstation. Other muscle and joint pain and/or discomfort will also be evaluated. We hypothesize that access to a sit-stand workstation will allow one to experience postural variation and reduce back pain. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Low Back Pain, Back Pain
What is being tested?: Sit-stand computer workstation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 1 siteUnited States
Study dates: Apr 2013to Mar 2014
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Back pain lasting ≥3 months and reported at a minimum of 4 out of 10 on the pain scale.
Sits >6 hours out of an 8-hour work day for work purposes
Able and willing to fill out a daily survey for the first week prior to randomization
Participants must be >18 years of age. There are no gender/race-ethnic restrictions.
Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

Unable to stand for at least 10 minutes.
Currently using a sit-stand desk

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Stanford, California, 94305

Other trials in United States

About this study

Official title: Evaluating Change in Back Pain From Access to a Sit-stand Workstation

Conditions: Low Back Pain, Back Pain
Being tested: Sit-stand computer workstation
Keywords: back pain, low back pain, sit-stand workstation, standing desk
Medical subject headings: Low Back Pain, Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sit-stand computer workstationOther
Also called Standing desk, WorkFit
A sit-stand computer workstation allows one to sit or stand throughout the day while maintaining continued use of one's computer.

Study groups in NCT02146482
Study group	Role	What they receive
Control	No intervention	Did not receive an intervention during the active portion of the study (i.e. 12 weeks). After the active portion of the study, this group was given a sit-stand computer workstation.
Sit-stand computer workstation	Experimental	Given a sit-stand computer workstation to use at their place of work Receives: Other: Sit-stand computer workstation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Back Pain
The Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain. The patient is asked to agree or disagree with 24 different statements related to their back pain. The end score is the sum of the agreed statements. The score ranges from 0 (no disability) to 24 (maximum disability).
Measured: Baseline (Week 1) and Follow-Up (Week 18)

Secondary outcomes (1)

Change in Pain in Other Body Parts
The Brief Pain Inventory (BPI) allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. This data was not analyzed due to the focus of the project on lower back pain.
Measured: At the conclusion of each work day for 12 weeks and 8 weeks later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013Mar 2014

First posted23 May 2014 (estimated)
Study startApr 2013
Primary completionDec 2013
Study completionMar 2014

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.
Publications (45)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
More trials run by Stanford 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02146482
Sponsor's protocol ID: SSCWStanford
Status last verified: Oct 2017
First submitted: 21 May 2014
Last updated: 6 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.
PubMed 14710506
Martin BI, Deyo RA, Mirza SK, Turner JA, Comstock BA, Hollingworth W, Sullivan SD. Expenditures and health status among adults with back and neck problems. JAMA. 2008 Feb 13;299(6):656-64. doi: 10.1001/jama.299.6.656.
PubMed 18270354
Hamilton MT, Healy GN, Dunstan DW, Zderic TW, Owen N. Too Little Exercise and Too Much Sitting: Inactivity Physiology and the Need for New Recommendations on Sedentary Behavior. Curr Cardiovasc Risk Rep. 2008 Jul;2(4):292-298. doi: 10.1007/s12170-008-0054-8.
PubMed 22905272
Morl F, Bradl I. Lumbar posture and muscular activity while sitting during office work. J Electromyogr Kinesiol. 2013 Apr;23(2):362-8. doi: 10.1016/j.jelekin.2012.10.002. Epub 2012 Nov 2.
PubMed 23122693
Hamburg NM, McMackin CJ, Huang AL, Shenouda SM, Widlansky ME, Schulz E, Gokce N, Ruderman NB, Keaney JF Jr, Vita JA. Physical inactivity rapidly induces insulin resistance and microvascular dysfunction in healthy volunteers. Arterioscler Thromb Vasc Biol. 2007 Dec;27(12):2650-6. doi: 10.1161/ATVBAHA.107.153288. Epub 2007 Oct 11.
PubMed 17932315
Ekblom-Bak E, Hellenius ML, Ekblom O, Engstrom LM, Ekblom B. Independent associations of physical activity and cardiovascular fitness with cardiovascular risk in adults. Eur J Cardiovasc Prev Rehabil. 2010 Apr;17(2):175-80. doi: 10.1097/HJR.0b013e32833254f2.
PubMed 19809331
Zderic TW, Hamilton MT. Physical inactivity amplifies the sensitivity of skeletal muscle to the lipid-induced downregulation of lipoprotein lipase activity. J Appl Physiol (1985). 2006 Jan;100(1):249-57. doi: 10.1152/japplphysiol.00925.2005. Epub 2005 Sep 29.
PubMed 16195388
Katzmarzyk PT, Church TS, Craig CL, Bouchard C. Sitting time and mortality from all causes, cardiovascular disease, and cancer. Med Sci Sports Exerc. 2009 May;41(5):998-1005. doi: 10.1249/MSS.0b013e3181930355.
PubMed 19346988
Pedersen BK. The diseasome of physical inactivity--and the role of myokines in muscle--fat cross talk. J Physiol. 2009 Dec 1;587(Pt 23):5559-68. doi: 10.1113/jphysiol.2009.179515. Epub 2009 Sep 14.
PubMed 19752112
Pedersen BK. Muscles and their myokines. J Exp Biol. 2011 Jan 15;214(Pt 2):337-46. doi: 10.1242/jeb.048074.
PubMed 21177953
Pillastrini P, Mugnai R, Bertozzi L, Costi S, Curti S, Guccione A, Mattioli S, Violante FS. Effectiveness of an ergonomic intervention on work-related posture and low back pain in video display terminal operators: a 3 year cross-over trial. Appl Ergon. 2010 May;41(3):436-43. doi: 10.1016/j.apergo.2009.09.008. Epub 2009 Oct 23.
PubMed 19853837
IJmker S, Huysmans MA, Blatter BM, van der Beek AJ, van Mechelen W, Bongers PM. Should office workers spend fewer hours at their computer? A systematic review of the literature. Occup Environ Med. 2007 Apr;64(4):211-22. doi: 10.1136/oem.2006.026468. Epub 2006 Nov 9.
PubMed 17095550
Robertson M, Amick BC 3rd, DeRango K, Rooney T, Bazzani L, Harrist R, Moore A. The effects of an office ergonomics training and chair intervention on worker knowledge, behavior and musculoskeletal risk. Appl Ergon. 2009 Jan;40(1):124-35. doi: 10.1016/j.apergo.2007.12.009. Epub 2008 Mar 11.
PubMed 18336791
Amick BC 3rd, Robertson MM, DeRango K, Bazzani L, Moore A, Rooney T, Harrist R. Effect of office ergonomics intervention on reducing musculoskeletal symptoms. Spine (Phila Pa 1976). 2003 Dec 15;28(24):2706-11. doi: 10.1097/01.BRS.0000099740.87791.F7.
PubMed 14673374
Aaras A, Horgen G, Bjorset HH, Ro O, Walsoe H. Musculoskeletal, visual and psychosocial stress in VDU operators before and after multidisciplinary ergonomic interventions. A 6 years prospective study--Part II. Appl Ergon. 2001 Dec;32(6):559-71. doi: 10.1016/s0003-6870(01)00030-8.
PubMed 11703042

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

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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating Change in Back Pain From Access to a Sit-stand Workstation
ClinicalTrials.gov ID: NCT02146482
Acronym / sponsor ID: SSCWStanford
Conditions: Low Back Pain, Back Pain
Keywords: back pain, low back pain, sit-stand workstation, standing desk
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: Apr 2013
Primary completion: Dec 2013 (actual)
Study completion: Mar 2014 (actual)
First posted: 23 May 2014 (estimated)
Results: Posted 19 Jun 2015

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control	No intervention	–Did not receive an intervention during the active portion of the study (i.e. 12 weeks). After the active portion of the study, this group was given a sit-stand computer workstation.
Sit-stand computer workstation	Experimental	Other: Sit-stand computer workstationGiven a sit-stand computer workstation to use at their place of work

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Back pain lasting ≥3 months and reported at a minimum of 4 out of 10 on the pain scale.
Sits >6 hours out of an 8-hour work day for work purposes
Able and willing to fill out a daily survey for the first week prior to randomization
Participants must be >18 years of age. There are no gender/race-ethnic restrictions.
Ability to understand and the willingness to sign a written informed consent document.

Key exclusion criteria (2 listed)

Unable to stand for at least 10 minutes.
Currently using a sit-stand desk

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
Sit-stand computer workstationAlso: Standing desk, WorkFitA sit-stand computer workstation allows one to sit or stand throughout the day while maintaining continued use of one's computer.	Other	Sit-stand computer workstation

Primary outcome

Change in Back Pain
Time frame: Baseline (Week 1) and Follow-Up (Week 18)
The Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain. The patient is asked to agree or disagree with 24 different statements related to their back pain. The end score is the sum of the agreed statements. The score ranges from 0 (no disability) to 24 (maximum disability).

1 secondary outcome

Change in Pain in Other Body Parts
Time frame: At the conclusion of each work day for 12 weeks and 8 weeks later

Results and safety

Results posted to the registry on 19 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	21	21
Sit-stand Computer Workstation	25	25

Primary outcome: Change in Back Pain

Time frame: Baseline (Week 1) and Follow-Up (Week 18). Median (Full Range). Unit: units on a scale

Measure	Control n = 21	Sit-stand Computer Workstation n = 25
Baseline	6 (0 to 15)	8.5 (1 to 15)
Follow Up	4 (0 to 12)	1.5 (0 to 19)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 21 (0%)	0 of 21 (0%)	Not reported
Sit-stand Computer Workstation	0 of 25 (0%)	0 of 25 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 14710506Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.
Background: PubMed 18270354Martin BI, Deyo RA, Mirza SK, Turner JA, Comstock BA, Hollingworth W, Sullivan SD. Expenditures and health status among adults with back and neck problems. JAMA. 2008 Feb 13;299(6):656-64. doi: 10.1001/jama.299.6.656.
Background: PubMed 22905272Hamilton MT, Healy GN, Dunstan DW, Zderic TW, Owen N. Too Little Exercise and Too Much Sitting: Inactivity Physiology and the Need for New Recommendations on Sedentary Behavior. Curr Cardiovasc Risk Rep. 2008 Jul;2(4):292-298. doi: 10.1007/s12170-008-0054-8.
Background: PubMed 23122693Morl F, Bradl I. Lumbar posture and muscular activity while sitting during office work. J Electromyogr Kinesiol. 2013 Apr;23(2):362-8. doi: 10.1016/j.jelekin.2012.10.002. Epub 2012 Nov 2.
Background: PubMed 17932315Hamburg NM, McMackin CJ, Huang AL, Shenouda SM, Widlansky ME, Schulz E, Gokce N, Ruderman NB, Keaney JF Jr, Vita JA. Physical inactivity rapidly induces insulin resistance and microvascular dysfunction in healthy volunteers. Arterioscler Thromb Vasc Biol. 2007 Dec;27(12):2650-6. doi: 10.1161/ATVBAHA.107.153288. Epub 2007 Oct 11.
Background: PubMed 19809331Ekblom-Bak E, Hellenius ML, Ekblom O, Engstrom LM, Ekblom B. Independent associations of physical activity and cardiovascular fitness with cardiovascular risk in adults. Eur J Cardiovasc Prev Rehabil. 2010 Apr;17(2):175-80. doi: 10.1097/HJR.0b013e32833254f2.
Background: PubMed 16195388Zderic TW, Hamilton MT. Physical inactivity amplifies the sensitivity of skeletal muscle to the lipid-induced downregulation of lipoprotein lipase activity. J Appl Physiol (1985). 2006 Jan;100(1):249-57. doi: 10.1152/japplphysiol.00925.2005. Epub 2005 Sep 29.
Background: PubMed 19346988Katzmarzyk PT, Church TS, Craig CL, Bouchard C. Sitting time and mortality from all causes, cardiovascular disease, and cancer. Med Sci Sports Exerc. 2009 May;41(5):998-1005. doi: 10.1249/MSS.0b013e3181930355.
Background: PubMed 19752112Pedersen BK. The diseasome of physical inactivity--and the role of myokines in muscle--fat cross talk. J Physiol. 2009 Dec 1;587(Pt 23):5559-68. doi: 10.1113/jphysiol.2009.179515. Epub 2009 Sep 14.
Background: PubMed 21177953Pedersen BK. Muscles and their myokines. J Exp Biol. 2011 Jan 15;214(Pt 2):337-46. doi: 10.1242/jeb.048074.
Background: PubMed 19853837Pillastrini P, Mugnai R, Bertozzi L, Costi S, Curti S, Guccione A, Mattioli S, Violante FS. Effectiveness of an ergonomic intervention on work-related posture and low back pain in video display terminal operators: a 3 year cross-over trial. Appl Ergon. 2010 May;41(3):436-43. doi: 10.1016/j.apergo.2009.09.008. Epub 2009 Oct 23.
Background: PubMed 17095550IJmker S, Huysmans MA, Blatter BM, van der Beek AJ, van Mechelen W, Bongers PM. Should office workers spend fewer hours at their computer? A systematic review of the literature. Occup Environ Med. 2007 Apr;64(4):211-22. doi: 10.1136/oem.2006.026468. Epub 2006 Nov 9.

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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.

Kathleen C Horst, MD principal investigator

Stanford 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 Sit-stand computer workstation in people with Low Back Pain and Back Pain, run by Stanford 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 5 inclusion and 2 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 6 Nov 2017. 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 19 Jun 2015). 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?

Change in Back Pain (time frame: Baseline (Week 1) and Follow-Up (Week 18)). 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 NCT02146482, which also lists 45 linked publications.

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 6 Nov 2017.