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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Central South University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hongbin Lu, Central South University
ClinicalTrials.gov Identifier:
NCT01483222
First received: November 26, 2011
Last updated: November 30, 2011
Last verified: November 2011

November 26, 2011
November 30, 2011
November 2011
November 2013   (final data collection date for primary outcome measure)
  • The incidences of low back pain [ Time Frame: 12 months after initiation ] [ Designated as safety issue: No ]
  • The sick leave days due to low back pain [ Time Frame: 12 months after initiation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01483222 on ClinicalTrials.gov Archive Site
  • Medical care utilization [ Time Frame: 12 months after initiation ] [ Designated as safety issue: No ]
  • Adverse Effects [ Time Frame: 12 months after initiation ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 months after initiation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Inelastic and Elastic Lumbosacral Orthoses on Low Back Pain Prevention in Hospital Nurses
Comparison of Inelastic and Elastic Lumbosacral Orthoses on Low Back Pain Prevention in Hospital Nurses

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Low Back Pain
  • Device: QUIKDRAW Pro, Aspen Medical Products
    Wearing an inelastic lumbar support (QUIKDRAW Pro, Aspen Medical Products) for 6 months
    Other Name: Lumbar belt, Lumbar orthoses, Lumbar brace
  • Device: MUELLER 4581, Mueller Sports Medicine
    Wearing an elastic lumbar support (MUELLER 4581, Mueller Sports Medicine) for 6 months
    Other Name: Lumbar belt, Lumbar orthoses, Lumbar brace
  • Experimental: QUIKDRAW Pro
    Wearing an inelastic lumbar support for 6 months
    Intervention: Device: QUIKDRAW Pro, Aspen Medical Products
  • Experimental: MUELLER 4581
    Wearing an elastic lumbar support for 6 months
    Intervention: Device: MUELLER 4581, Mueller Sports Medicine
  • No Intervention: Blank Control
    Receiving no intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Female
20 Years to 25 Years
Yes
Contact: Hongbin Lu, M.D. & Ph.D. 86-0731-84327174 hongbinlu@hotmail.com
China
 
NCT01483222
20101201
Yes
Hongbin Lu, Central South University
Central South University
Not Provided
Principal Investigator: Hongbin Lu, M.D. & Ph.D. Xiangya Hospital of Central South University
Central South University
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP