Low Back PainNCT01483222
Comparison of Inelastic and Elastic Lumbosacral Orthoses on Low Back Pain Prevention in Hospital Nurses
A study testing QUIKDRAW Pro, Aspen Medical Products and MUELLER 4581, Mueller Sports Medicine in people with Low Back Pain, run by Central South University at 1 site in China.
Trial summary
The main objective of this study is to investigate the efficacy of two different design characteristics of lumbar support for low back pain prevention in hospital nurses. Read more about this study
- Who is it for?
- Ages 20 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- QUIKDRAW Pro, Aspen Medical Products and MUELLER 4581, Mueller Sports Medicine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to Jun 2013
- 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 20 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female between 20 and 25 years of age
- Subjects who have worked as a nurse less than two years and will continue working as a nurse no less than one year
- Job contents including moving and lifting patients, long-time standing and frequent bending
- Subjects who do not participate any other study concerning pain prevention currently and in the next year
Who cannot join
- Subjects who are experiencing low back pain symptoms at the time of inquiry, regardless of acute or chronic, and seeking medical care currently
- Subjects who have experienced 2 or more episodes (on 2 consecutive days) of low back pain symptoms in the 12 months before the inquiry
- Subjects who are suffering from any other chronic pain disorders symptomatically
- Subjects who have used a lumbar support during the last 6 months
- Subjects with specific low back pain (like infection, tumors, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome or cauda equina syndrome, spinal stenosis or spondylolysis)
- Subjects who have had a spinal operation
Show all 11Show fewer
- Subjects who are suffering from chronic cardiac, respiratory, liver and kidney complaint symptomatically
- Subjects who are suffering from diseases that might be aggravated by increased intra-abdominal pressure, like hernia
- Subjects who are suffering from chronic gastrointestinal disorders symptomatically
- Subjects who are pregnant, planning to have a baby in 1 year or less than 6 months after delivery
- Subjects who are suffering from serious somatic disease and/or psychic disease
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this study is to investigate the efficacy of two different design characteristics of lumbar support for low back pain prevention in hospital nurses.
Read the detailed description
Low back pain occurs frequently and is one of the most costly health problems affecting industry and society. Prevention of low back pain is important both for the individual patient and from an economic perspective. Therefore, there are many measures available that claim to reduce low back pain and its recurrence. The most commonly used preventive strategies are fitness exercises, lumbar supports, education on back mechanics and lifting techniques, and ergonomic adjustments. However, their efficacy is still uncertain. The main objective of this study is to investigate the efficacy of two different design characteristics of lumbar support for low back pain prevention in hospital nurses. Investigators hope that those two types of lumbar support will reduce the incidence of low back pain and sick leave days. In addition, Investigators hypothesize that there are some differences on outcome measures between those two types of lumbar support. Enrolled subjects will be randomly assigned to one of the following three groups. The first group will wear an inelastic lumbar support for 6 months. The second group will wear an elastic lumbar support for 6 months. The third group will receive no intervention. After the completion of 6-month intervention, a further 6 months fellow-up will be added.
- Conditions
- Low Back Pain
- Being tested
- QUIKDRAW Pro, Aspen Medical Products, MUELLER 4581, Mueller Sports Medicine
- Keywords
- Low Back Pain, Braces, Prevention
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QUIKDRAW Pro, Aspen Medical ProductsDevice
Also called Lumbar belt, Lumbar orthoses, Lumbar brace
Wearing an inelastic lumbar support (QUIKDRAW Pro, Aspen Medical Products) for 6 months
MUELLER 4581, Mueller Sports MedicineDevice
Also called Lumbar belt, Lumbar orthoses, Lumbar brace
Wearing an elastic lumbar support (MUELLER 4581, Mueller Sports Medicine) for 6 months
| Study group | Role | What they receive |
|---|---|---|
| QUIKDRAW Pro | Experimental | Wearing an inelastic lumbar support for 6 months Receives: Device: QUIKDRAW Pro, Aspen Medical Products |
| MUELLER 4581 | Experimental | Wearing an elastic lumbar support for 6 months Receives: Device: MUELLER 4581, Mueller Sports Medicine |
| Blank Control | No intervention | Receiving no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidences of low back pain
Measured: 12 months after initiation
The sick leave days due to low back pain
Measured: 12 months after initiation
Secondary outcomes (3)
Medical care utilization
Measured: 12 months after initiation
Adverse Effects
Measured: 12 months after initiation
Quality of life
Measured: 12 months after initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongbin Lu, Central South University
- Investigators
- Hongbin Lu, M.D. & Ph.D., Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483222
- Sponsor's protocol ID
- 20101201
- Status last verified
- Oct 2014
- First submitted
- 26 Nov 2011
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Inelastic and Elastic Lumbosacral Orthoses on Low Back Pain Prevention in Hospital Nurses
- ClinicalTrials.gov ID
- NCT01483222
- Acronym / sponsor ID
- 20101201
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Braces, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 1 Dec 2011 (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.
The main objective of this study is to investigate the efficacy of two different design characteristics of lumbar support for low back pain prevention in hospital nurses.
Detailed description
Low back pain occurs frequently and is one of the most costly health problems affecting industry and society. Prevention of low back pain is important both for the individual patient and from an economic perspective. Therefore, there are many measures available that claim to reduce low back pain and its recurrence. The most commonly used preventive strategies are fitness exercises, lumbar supports, education on back mechanics and lifting techniques, and ergonomic adjustments. However, their efficacy is still uncertain. The main objective of this study is to investigate the efficacy of two different design characteristics of lumbar support for low back pain prevention in hospital nurses. Investigators hope that those two types of lumbar support will reduce the incidence of low back pain and sick leave days. In addition, Investigators hypothesize that there are some differences on outcome measures between those two types of lumbar support. Enrolled subjects will be randomly assigned to one of the following three groups. The first group will wear an inelastic lumbar support for 6 months. The second group will wear an elastic lumbar support for 6 months. The third group will receive no intervention. After the completion of 6-month intervention, a further 6 months fellow-up will be added.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QUIKDRAW Pro | Experimental | Device: QUIKDRAW Pro, Aspen Medical ProductsWearing an inelastic lumbar support for 6 months |
| MUELLER 4581 | Experimental | Device: MUELLER 4581, Mueller Sports MedicineWearing an elastic lumbar support for 6 months |
| Blank Control | No intervention | –Receiving no intervention |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female between 20 and 25 years of age
- Subjects who have worked as a nurse less than two years and will continue working as a nurse no less than one year
- Job contents including moving and lifting patients, long-time standing and frequent bending
- Subjects who do not participate any other study concerning pain prevention currently and in the next year
Key exclusion criteria (11 listed)
- Subjects who are experiencing low back pain symptoms at the time of inquiry, regardless of acute or chronic, and seeking medical care currently
- Subjects who have experienced 2 or more episodes (on 2 consecutive days) of low back pain symptoms in the 12 months before the inquiry
- Subjects who are suffering from any other chronic pain disorders symptomatically
- Subjects who have used a lumbar support during the last 6 months
- Subjects with specific low back pain (like infection, tumors, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome or cauda equina syndrome, spinal stenosis or spondylolysis)
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 |
|---|---|---|
| QUIKDRAW Pro, Aspen Medical ProductsAlso: Lumbar belt, Lumbar orthoses, Lumbar braceWearing an inelastic lumbar support (QUIKDRAW Pro, Aspen Medical Products) for 6 months | Device | QUIKDRAW Pro |
| MUELLER 4581, Mueller Sports MedicineAlso: Lumbar belt, Lumbar orthoses, Lumbar braceWearing an elastic lumbar support (MUELLER 4581, Mueller Sports Medicine) for 6 months | Device | MUELLER 4581 |
Primary outcome
The incidences of low back pain
Time frame: 12 months after initiation
The sick leave days due to low back pain
Time frame: 12 months after initiation
3 secondary outcomes
Medical care utilization
Time frame: 12 months after initiation
Adverse Effects
Time frame: 12 months after initiation
Quality of life
Time frame: 12 months after initiation
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 15 Oct 2014.
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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.
Hongbin Lu, M.D. & Ph.D. principal investigator
Xiangya Hospital of Central South 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 QUIKDRAW Pro, Aspen Medical Products and MUELLER 4581, Mueller Sports Medicine in people with Low Back Pain, run by Central South University at 1 site in China.
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 4 inclusion and 11 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 15 Oct 2014. 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 China. 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.
What does the primary outcome measure?
The incidences of low back pain (time frame: 12 months after initiation). 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 15 Oct 2014.