Back to resultsComparison of Inelastic and Elastic Lumbosacral Orthoses on Low Back Pain Prevention in Hospital Nurses
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
QUIKDRAW Pro, Aspen Medical Products
MUELLER 4581, Mueller Sports Medicine
Sponsored by
About this trial
This is an interventional prevention trial for Low Back Pain focused on measuring Low Back Pain, Braces, Prevention
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Xiangya Hospital, Central South University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
QUIKDRAW Pro
MUELLER 4581
Blank Control
Arm Description
Wearing an inelastic lumbar support for 6 months
Wearing an elastic lumbar support for 6 months
Receiving no intervention
Outcomes
Primary Outcome Measures
The incidences of low back pain
The sick leave days due to low back pain
Secondary Outcome Measures
Medical care utilization
Adverse Effects
Quality of life
Full Information
NCT ID
NCT01483222
First Posted
November 26, 2011
Last Updated
October 14, 2014
Sponsor
Central South University
1. Study Identification
Unique Protocol Identification Number
NCT01483222
Brief Title
Comparison of Inelastic and Elastic Lumbosacral Orthoses on Low Back Pain Prevention in Hospital Nurses
Official Title
Comparison of Inelastic and Elastic Lumbosacral Orthoses on Low Back Pain Prevention in Hospital Nurses
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low Back Pain, Braces, Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
QUIKDRAW Pro
Arm Type
Experimental
Arm Description
Wearing an inelastic lumbar support for 6 months
Arm Title
MUELLER 4581
Arm Type
Experimental
Arm Description
Wearing an elastic lumbar support for 6 months
Arm Title
Blank Control
Arm Type
No Intervention
Arm Description
Receiving no intervention
Intervention Type
Device
Intervention Name(s)
QUIKDRAW Pro, Aspen Medical Products
Other Intervention Name(s)
Lumbar belt, Lumbar orthoses, Lumbar brace
Intervention Description
Wearing an inelastic lumbar support (QUIKDRAW Pro, Aspen Medical Products) for 6 months
Intervention Type
Device
Intervention Name(s)
MUELLER 4581, Mueller Sports Medicine
Other Intervention Name(s)
Lumbar belt, Lumbar orthoses, Lumbar brace
Intervention Description
Wearing an elastic lumbar support (MUELLER 4581, Mueller Sports Medicine) for 6 months
Primary Outcome Measure Information:
Title
The incidences of low back pain
Time Frame
12 months after initiation
Title
The sick leave days due to low back pain
Time Frame
12 months after initiation
Secondary Outcome Measure Information:
Title
Medical care utilization
Time Frame
12 months after initiation
Title
Adverse Effects
Time Frame
12 months after initiation
Title
Quality of life
Time Frame
12 months after initiation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongbin Lu, M.D. & Ph.D.
Organizational Affiliation
Xiangya Hospital of Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
12. IPD Sharing Statement
Learn more about this trial
Comparison of Inelastic and Elastic Lumbosacral Orthoses on Low Back Pain Prevention in Hospital Nurses
We'll reach out to this number within 24 hrs