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Completed

NCT Number: NCT01483222

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.

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Key information

Age range

20 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QUIKDRAW Pro, Aspen Medical Products

Device

Wearing an inelastic lumbar support (QUIKDRAW Pro, Aspen Medical Products) for 6 months

Other names: Lumbar belt, Lumbar orthoses, Lumbar brace

MUELLER 4581, Mueller Sports Medicine

Device

Wearing an elastic lumbar support (MUELLER 4581, Mueller Sports Medicine) for 6 months

Other names: Lumbar belt, Lumbar orthoses, Lumbar brace

Primary outcomes

  1. The incidences of low back pain

    Time frame: 12 months after initiation

  2. The sick leave days due to low back pain

    Time frame: 12 months after initiation

Secondary outcomes

  1. Medical care utilization

    Time frame: 12 months after initiation

  2. Adverse Effects

    Time frame: 12 months after initiation

  3. Quality of life

    Time frame: 12 months after initiation

Sponsors and collaborators

Lead sponsor

Central South University

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 1, 2011
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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