Back PainNCT00012844
Redesigning Patient Handling Tasks to Prevent Nursing Back Injuries
A study testing Redesigning patient handling tasks using equip: Arjo Bianca Overhead Lift, Hill-Rom Resident Transfer Device, TranSit Chair, Total Care Bed in people with Back Pain and Occupational Diseases, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This study is one of several initiated by the investigators to reduce musculoskeletal injuries in patient care providers. Nurses have one of the highest incidences of work related back injuries of any profession. Over the past 20 years, efforts to reduce work-related injuries in nursing have been largely unsuccessful. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Back Pain, Occupational Diseases
- What is being tested?
- Redesigning patient handling tasks using equip: Arjo Bianca Overhead Lift, Hill-Rom Resident Transfer Device, TranSit Chair, Total Care Bed
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Dec 1999
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects included RNs, LPNs, and Nas with a minimum of 6 months experience and a job description that included a minimum of 80% direct patient care responsibilities. Subjects were required to be injury free for at least one year, as evidenced by a brief orthopedic examination and interview. The orthopedic evaluation included an examination of posture, gait, range of motion, sensory deficits, muscle exam, and straight leg raise. We excluded subjects with self-report of injury or any positive finding of back musculoskeletal disorders within the past 12 months.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
About this study
This study is one of several initiated by the investigators to reduce musculoskeletal injuries in patient care providers. Nurses have one of the highest incidences of work related back injuries of any profession. Over the past 20 years, efforts to reduce work-related injuries in nursing have been largely unsuccessful.
Read the detailed description
Background:
This study is one of several initiated by the investigators to reduce musculoskeletal injuries in patient care providers. Nurses have one of the highest incidences of work related back injuries of any profession. Over the past 20 years, efforts to reduce work-related injuries in nursing have been largely unsuccessful.
Objectives:
The goal of this study is to reduce the incidence and severity of occupational musculoskeletal injuries in nursing through the redesign of stressful patient handling tasks. This study addresses three objectives: 1) conduct a quantitative, biomechanically based, ergonomic evaluation of the eleven "at risk" tasks in nursing practice; 2) redesign the techniques or equipment needed to perform these tasks safely or with reduced risk of musculoskeletal injury; and 3) conduct laboratory- based assessment of the biomechanical benefit of the proposed intervention strategies.
Methods:
Using a randomized experimental design with a control group, ten "at risk" tasks will be evaluated. The sample included 160 experienced nursing staff. Data were collected using: 1) Caregiver Data Form and Anthropometry Data Sheet; 2) 3-D Electromagnetic Tracking System; 3) EMG; and 4) modified Borg Scale for Perceived Comfort. Include: caregiver characteristics, joint torque, spinal forces, spinal tolerance limit and damage load limit, erector spinae surface EMG, joint angles, percent of population capable of performing each task by gender, velocity of lift, reach, heart rate, and perceived comfort.
Status:
This project is complete.
- Conditions
- Back Pain, Occupational Diseases
- Being tested
- Redesigning patient handling tasks using equip: Arjo Bianca Overhead Lift, Hill-Rom Resident Transfer Device, TranSit Chair, Total Care Bed, Redesigned patient handling tasks using work practice controls: setting bed height at correct level; applying anti-embolism stockings from foot of bed
- Keywords
- Musculoskeletal Disorders, Patient Lifting, Occupational Accidents
- Medical subject headings
- Back Pain, Occupational Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Redesigning patient handling tasks using equip: Arjo Bianca Overhead Lift, Hill-Rom Resident Transfer Device, TranSit Chair, Total Care BedDevice
Redesigned patient handling tasks using work practice controls: setting bed height at correct level; applying anti-embolism stockings from foot of bedProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Device: Redesigning patient handling tasks using equip: Arjo Bianca Overhead Lift, Hill-Rom Resident Transfer Device, TranSit Chair, Total Care Bed; Procedure: Redesigned patient handling tasks using work practice controls: setting bed height at correct level; applying anti-embolism stockings from foot of bed |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study completionDec 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Audrey L. Nelson, RN PhD FAAN, Principal investigator, James A. Haley Veterans' Hospital, Tampa, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00012844
- Sponsor's protocol ID
- NRI 95-150
- Status last verified
- Feb 2007
- First submitted
- 14 Mar 2001
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Redesigning Patient Handling Tasks to Prevent Nursing Back Injuries
- ClinicalTrials.gov ID
- NCT00012844
- Acronym / sponsor ID
- NRI 95-150
- Conditions
- Back Pain, Occupational Diseases
- Keywords
- Musculoskeletal Disorders, Patient Lifting, Occupational Accidents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Dec 1999 (actual)
- First posted
- 16 Mar 2001 (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 study is one of several initiated by the investigators to reduce musculoskeletal injuries in patient care providers. Nurses have one of the highest incidences of work related back injuries of any profession. Over the past 20 years, efforts to reduce work-related injuries in nursing have been largely unsuccessful.
Detailed description
Background:
This study is one of several initiated by the investigators to reduce musculoskeletal injuries in patient care providers. Nurses have one of the highest incidences of work related back injuries of any profession. Over the past 20 years, efforts to reduce work-related injuries in nursing have been largely unsuccessful.
Objectives:
The goal of this study is to reduce the incidence and severity of occupational musculoskeletal injuries in nursing through the redesign of stressful patient handling tasks. This study addresses three objectives: 1) conduct a quantitative, biomechanically based, ergonomic evaluation of the eleven "at risk" tasks in nursing practice; 2) redesign the techniques or equipment needed to perform these tasks safely or with reduced risk of musculoskeletal injury; and 3) conduct laboratory- based assessment of the biomechanical benefit of the proposed intervention strategies.
Methods:
Using a randomized experimental design with a control group, ten "at risk" tasks will be evaluated. The sample included 160 experienced nursing staff. Data were collected using: 1) Caregiver Data Form and Anthropometry Data Sheet; 2) 3-D Electromagnetic Tracking System; 3) EMG; and 4) modified Borg Scale for Perceived Comfort. Include: caregiver characteristics, joint torque, spinal forces, spinal tolerance limit and damage load limit, erector spinae surface EMG, joint angles, percent of population capable of performing each task by gender, velocity of lift, reach, heart rate, and perceived comfort.
Status:
This project is complete.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Device: Redesigning patient handling tasks using equip: Arjo Bianca Overhead Lift, Hill-Rom Resident Transfer Device, TranSit Chair, Total Care Bed, Procedure: Redesigned patient handling tasks using work practice controls: setting bed height at correct level; applying anti-embolism stockings from foot of bed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects included RNs, LPNs, and Nas with a minimum of 6 months experience and a job description that included a minimum of 80% direct patient care responsibilities. Subjects were required to be injury free for at least one year, as evidenced by a brief orthopedic examination and interview. The orthopedic evaluation included an examination of posture, gait, range of motion, sensory deficits, muscle exam, and straight leg raise. We excluded subjects with self-report of injury or any positive finding of back musculoskeletal disorders within the past 12 months.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Redesigning patient handling tasks using equip: Arjo Bianca Overhead Lift, Hill-Rom Resident Transfer Device, TranSit Chair, Total Care Bed | Device | Arm 1 |
| Redesigned patient handling tasks using work practice controls: setting bed height at correct level; applying anti-embolism stockings from foot of bed | Procedure or surgery | Arm 1 |
Primary outcome
Not reported in the source record.
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 7 Apr 2015.
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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.
Audrey L. Nelson, RN PhD FAAN principal investigator
James A. Haley Veterans' Hospital, Tampa, FL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Redesigning patient handling tasks using equip: Arjo Bianca Overhead Lift, Hill-Rom Resident Transfer Device, TranSit Chair, Total Care Bed in people with Back Pain and Occupational Diseases, run by US Department of Veterans Affairs 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 1 inclusion and 0 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 7 Apr 2015. 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?
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.
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 7 Apr 2015.