NCT01483222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

1.6 years

First QC Date

November 26, 2011

Last Update Submit

October 14, 2014

Conditions

Low Back Pain

Keywords

Low Back PainBracesPrevention

Outcome Measures

Primary Outcomes (2)

  • The incidences of low back pain

    12 months after initiation

  • The sick leave days due to low back pain

    12 months after initiation

Secondary Outcomes (3)

  • Medical care utilization

    12 months after initiation

  • Adverse Effects

    12 months after initiation

  • Quality of life

    12 months after initiation

Study Arms (3)

QUIKDRAW Pro

EXPERIMENTAL

Wearing an inelastic lumbar support for 6 months

Device: QUIKDRAW Pro, Aspen Medical Products

MUELLER 4581

EXPERIMENTAL

Wearing an elastic lumbar support for 6 months

Device: MUELLER 4581, Mueller Sports Medicine

Blank Control

NO INTERVENTION

Receiving no intervention

Interventions

QUIKDRAW Pro, Aspen Medical ProductsDEVICE

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

Also known as: Lumbar belt, Lumbar orthoses, Lumbar brace
QUIKDRAW Pro
MUELLER 4581, Mueller Sports MedicineDEVICE

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

Also known as: Lumbar belt, Lumbar orthoses, Lumbar brace
MUELLER 4581

Eligibility Criteria

Age20 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hongbin Lu, M.D. & Ph.D.

    Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 26, 2011

First Posted

December 1, 2011

Study Start

November 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

October 15, 2014

Record last verified: 2014-10

Locations

CN(1)