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

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Device: MUELLER 4581, Mueller Sports Medicine; Device: QUIKDRAW Pro, Aspen Medical Products

• Registration Number: NCT01483222
• Lead Sponsor: Central South University

Brief 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.

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 Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-26
• Study First Submitted QC: 2011-11-29
• Study First Posted: 2011-12-01
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MUELLER 4581	MUELLER 4581, Mueller Sports Medicine	Wearing an elastic lumbar support for 6 months
QUIKDRAW Pro	QUIKDRAW Pro, Aspen Medical Products	Wearing an inelastic lumbar support for 6 months

Primary Outcome Measures

Name	Time	Method
The incidences of low back pain	12 months after initiation
The sick leave days due to low back pain	12 months after initiation

Secondary Outcome Measures

Name	Time	Method
Medical care utilization	12 months after initiation
Quality of life	12 months after initiation
Adverse Effects	12 months after initiation

Trial Locations

Locations (1)

Xiangya Hospital, Central South University; 🇨🇳 Changsha, Hunan, China