Clinical trial NCT01483222: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain
Braces
Prevention
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2011-12-01
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. Female between 20 and 25 years of age
2. Subjects who have worked as a nurse less than two years and will continue working as a nurse no less than one year
3. Job contents including moving and lifting patients, long-time standing and frequent bending
4. Subjects who do not participate any other study concerning pain prevention currently and in the next year

Exclusion Criteria:

1. Subjects who are experiencing low back pain symptoms at the time of inquiry, regardless of acute or chronic, and seeking medical care currently
2. Subjects who have experienced 2 or more episodes (on 2 consecutive days) of low back pain symptoms in the 12 months before the inquiry
3. Subjects who are suffering from any other chronic pain disorders symptomatically
4. Subjects who have used a lumbar support during the last 6 months
5. 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)
6. Subjects who have had a spinal operation
7. Subjects who are suffering from chronic cardiac, respiratory, liver and kidney complaint symptomatically
8. Subjects who are suffering from diseases that might be aggravated by increased intra-abdominal pressure, like hernia
9. Subjects who are suffering from chronic gastrointestinal disorders symptomatically
10. Subjects who are pregnant, planning to have a baby in 1 year or less than 6 months after delivery
11. Subjects who are suffering from serious somatic disease and/or psychic disease

Primary outcomes:
measure: The incidences of low back pain
timeFrame: 12 months after initiation
measure: The sick leave days due to low back pain
timeFrame: 12 months after initiation
Secondary outcomes:
measure: Medical care utilization
timeFrame: 12 months after initiation
measure: Adverse Effects
timeFrame: 12 months after initiation
measure: Quality of life
timeFrame: 12 months after initiation
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Hongbin Lu, M.D. & Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: