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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483222
• Other study ID #: 20101201
• Status: Completed
• Phase: N/A
• First received: November 26, 2011
• Last updated: October 14, 2014
• Start date: November 2011
• Est. completion date: June 2013

Study information

• Verified date: October 2014
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 25 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• QUIKDRAW Pro, Aspen Medical Products
Wearing an inelastic lumbar support (QUIKDRAW Pro, Aspen Medical Products) for 6 months
• MUELLER 4581, Mueller Sports Medicine
Wearing an elastic lumbar support (MUELLER 4581, Mueller Sports Medicine) for 6 months

Locations

Country	Name	City	State
China	Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidences of low back pain		12 months after initiation	No
Primary	The sick leave days due to low back pain		12 months after initiation	No
Secondary	Medical care utilization		12 months after initiation	No
Secondary	Adverse Effects		12 months after initiation	No
Secondary	Quality of life		12 months after initiation	No