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

This study is currently recruiting participants.
Verified November 2011 by Central South University
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
History of Changes
  Purpose

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.


Condition Intervention
Low Back Pain
 Device: QUIKDRAW Pro, Aspen Medical Products
Device: MUELLER 4581, Mueller Sports Medicine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Inelastic and Elastic Lumbosacral Orthoses on Low Back Pain Prevention in Hospital Nurses

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Central South University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: November 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Lumbar belt, Lumbar orthoses, Lumbar brace
No Intervention: Blank Control
Receiving no intervention

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

Ages Eligible for Study:   20 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483222

Contacts
Contact: Hongbin Lu, M.D. & Ph.D. 86-0731-84327174 hongbinlu@hotmail.com

Locations
China, Hunan
Xiangya Hospital, Central South University Recruiting
Changsha, Hunan, China, 410008
Contact: Hongbin Lu, M.D. & Ph.D.     86-0731-84327174     hongbinlu@hotmail.com    
Sponsors and Collaborators
Central South University
Investigators
Principal Investigator: Hongbin Lu, M.D. & Ph.D. Xiangya Hospital, Central South University
  More Information

No publications provided

Responsible Party: Hongbin Lu, Professor, Central South University
ClinicalTrials.gov Identifier: NCT01483222     History of Changes
Other Study ID Numbers: 20101201
Study First Received: November 26, 2011
Last Updated: November 30, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Central South University:
Low Back Pain
Braces
Prevention

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013