Low Back PainPhase 4NCT00791596
Effectiveness of Ergonomic Intervention
A Phase 4 study testing Ergonomic Intervention in people with Low Back Pain and Neck Pain, run by University of Bologna at 1 site in Italy.
Trial summary
This Research study aims to investigate the long term effectiveness of a workstation ergonomic intervention for work-related posture and low back pain (LBP) of Video Display Terminal (VDT) workers Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Low Back Pain, Neck Pain, Upper Extremity
- What is being tested?
- Ergonomic Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2005to Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study population was composed of 400 employees, who used VDTs for at least 20 hours a week
Who cannot join
- Subjects were excluded if pregnant or had a medical history of serious injury, spinal surgery, malignant pathology, or severe disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Ergonomic Intervention on Work-Related Posture and Low Back Pain in Video Display Terminal Operators: a 3 Year Cross-Over Trial
This Research study aims to investigate the long term effectiveness of a workstation ergonomic intervention for work-related posture and low back pain (LBP) of Video Display Terminal (VDT) workers
Read the detailed description
A non-randomized, crossover trial design was used with follow-up repeated 6, 12, and 30 months from baseline in the first intervention period and then beginning at 6 months following the crossover.
The administrative offices in the two main buildings of the town hall of Forlì, Italy.
The study population was composed of 400 employees, who used VDTs for at least 20 hours a week, of whom we randomly selected 100 participants from each building. Of the 200 initial participants, 153 completed the study; the dropouts were due to illness/injury or maternity.
Participants were assigned to intervention or control during the first period and then crossed over after a 30-month washout. The intervention used in this investigation was an ergonomic adjustment of the VDT workstation design.
Our study showed that the workstation ergonomic adjustment improved work-related posture and in reducing LBP in VDT operators among subjects who received the intervention both in the first period and in the crossover, and maintained these positive effects for at least 30 months.
- Conditions
- Low Back Pain, Neck Pain, Upper Extremity, Lower Extremity
- Being tested
- Ergonomic Intervention
- Keywords
- Ergonomic intervention, Musculoskeletal disorders, Low back pain, Posture, Video display terminal
- Medical subject headings
- Low Back Pain, Neck Pain, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergonomic InterventionOther
Also called Preventive Intervention of Musculoskeletal Disorders
The intervention used in this investigation was an ergonomic adjustment of the VDT workstation design
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The first Arm received the intervention between baseline and the first follow-up, whereas the second Arm was the Control group Receives: Other: Ergonomic Intervention |
| 2 | Experimental | The second Arm received the intervention between the third and the fourth follow-up, whereas the first Arm was the Control group Receives: Other: Ergonomic Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
R.E.B.A. (Rapid Entire Body Assessment) method
Measured: Baseline, 6 months, 12 months, 30 months, 36 months
Secondary outcomes (1)
Pain Drawing with a Visual Analogue Scale
Measured: Baseline, 6 months, 12 months, 30 months, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startJan 2005
- Primary completionJun 2005
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Investigators
- Paolo Pillastrini, MSc, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791596
- Sponsor's protocol ID
- PP001012008
- Status last verified
- Oct 2008
- First submitted
- 13 Nov 2008
- Last updated
- 14 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Pillastrini P, Mugnai R, Farneti C, Bertozzi L, Bonfiglioli R, Curti S, Mattioli S, Violante FS. Evaluation of two preventive interventions for reducing musculoskeletal complaints in operators of video display terminals. Phys Ther. 2007 May;87(5):536-44. doi: 10.2522/ptj.20060092. Epub 2007 Apr 3.
PubMed 17405805Pillastrini 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Ergonomic Intervention on Work-Related Posture and Low Back Pain in Video Display Terminal Operators: a 3 Year Cross-Over Trial
- ClinicalTrials.gov ID
- NCT00791596
- Acronym / sponsor ID
- PP001012008
- Conditions
- Low Back Pain, Neck Pain, Upper Extremity, Lower Extremity
- Keywords
- Ergonomic intervention, Musculoskeletal disorders, Low back pain, Posture, Video display terminal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jun 2005 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 14 Nov 2008 (estimated)
- 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.
This Research study aims to investigate the long term effectiveness of a workstation ergonomic intervention for work-related posture and low back pain (LBP) of Video Display Terminal (VDT) workers
Detailed description
A non-randomized, crossover trial design was used with follow-up repeated 6, 12, and 30 months from baseline in the first intervention period and then beginning at 6 months following the crossover.
The administrative offices in the two main buildings of the town hall of Forlì, Italy.
The study population was composed of 400 employees, who used VDTs for at least 20 hours a week, of whom we randomly selected 100 participants from each building. Of the 200 initial participants, 153 completed the study; the dropouts were due to illness/injury or maternity.
Participants were assigned to intervention or control during the first period and then crossed over after a 30-month washout. The intervention used in this investigation was an ergonomic adjustment of the VDT workstation design.
Our study showed that the workstation ergonomic adjustment improved work-related posture and in reducing LBP in VDT operators among subjects who received the intervention both in the first period and in the crossover, and maintained these positive effects for at least 30 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Ergonomic InterventionThe first Arm received the intervention between baseline and the first follow-up, whereas the second Arm was the Control group |
| 2 | Experimental | Other: Ergonomic InterventionThe second Arm received the intervention between the third and the fourth follow-up, whereas the first Arm was the Control group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study population was composed of 400 employees, who used VDTs for at least 20 hours a week
Key exclusion criteria (1 listed)
- Subjects were excluded if pregnant or had a medical history of serious injury, spinal surgery, malignant pathology, or severe disability
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 |
|---|---|---|
| Ergonomic InterventionAlso: Preventive Intervention of Musculoskeletal DisordersThe intervention used in this investigation was an ergonomic adjustment of the VDT workstation design | Other | 1, 2 |
Primary outcome
R.E.B.A. (Rapid Entire Body Assessment) method
Time frame: Baseline, 6 months, 12 months, 30 months, 36 months
1 secondary outcome
Pain Drawing with a Visual Analogue Scale
Time frame: Baseline, 6 months, 12 months, 30 months, 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2008.
- Results publication: PubMed 17405805Pillastrini P, Mugnai R, Farneti C, Bertozzi L, Bonfiglioli R, Curti S, Mattioli S, Violante FS. Evaluation of two preventive interventions for reducing musculoskeletal complaints in operators of video display terminals. Phys Ther. 2007 May;87(5):536-44. doi: 10.2522/ptj.20060092. Epub 2007 Apr 3.
- Derived from this study: 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.
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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.
Paolo Pillastrini, MSc principal investigator
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ergonomic Intervention in people with Low Back Pain and Neck Pain, run by University of Bologna at 1 site in Italy.
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 1 inclusion and 1 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 Nov 2008. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
R.E.B.A. (Rapid Entire Body Assessment) method (time frame: Baseline, 6 months, 12 months, 30 months, 36 months). 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 NCT00791596, which also lists 2 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 14 Nov 2008.