Comparison of Inelastic and Elastic Lumbosacral Orthoses on Low Back Pain Prevention in Hospital Nurses

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Inelastic and Elastic Lumbosacral Orthoses on Low Back Pain Prevention in Hospital Nurses

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: QUIKDRAW Pro, Aspen Medical Products
* Device: MUELLER 4581, Mueller Sports Medicine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QUIKDRAW Pro<br>Wearing an inelastic lumbar support for 6 months | Device: QUIKDRAW Pro, Aspen Medical Products<br>* Wearing an inelastic lumbar support (QUIKDRAW Pro, Aspen Medical Products) for 6 months<br>* Other names: Lumbar belt, Lumbar orthoses, Lumbar brace;|
| Experimental: MUELLER 4581<br>Wearing an elastic lumbar support for 6 months | Device: MUELLER 4581, Mueller Sports Medicine<br>* Wearing an elastic lumbar support (MUELLER 4581, Mueller Sports Medicine) for 6 months<br>* Other names: Lumbar belt, Lumbar orthoses, Lumbar brace;|
| No Intervention: Blank Control<br>Receiving no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidences of low back pain |  | 12 months after initiation | 
| The sick leave days due to low back pain |  | 12 months after initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical care utilization |  | 12 months after initiation | 
| Adverse Effects |  | 12 months after initiation | 
| Quality of life |  | 12 months after initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Back Pain, Braces, Prevention