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

October 14, 2014 updated by: Hongbin Lu, Central South University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital, Central South University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central South University

Investigators

  • Principal Investigator: Hongbin Lu, M.D. & Ph.D., Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

November 26, 2011

First Submitted That Met QC Criteria

November 29, 2011

First Posted (Estimate)

December 1, 2011

Study Record Updates

Last Update Posted (Estimate)

October 15, 2014

Last Update Submitted That Met QC Criteria

October 14, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20101201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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