Prevention of Low Back Pain in the Military - Full Text View

Sponsors and Collaborators:	University of Florida Brooke Army Medical Center
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00373009

Purpose

We are studying whether specific back exercise and education programs effectively limit the development of chronic low back pain in Soldiers in the United States Army. These programs represent the current best evidence for prevention of low back pain from an exercise and education perspective. This innovative study will investigate whether a combination of evidence-based exercise and education programs effectively decreases the impact of chronic low back pain, when compared to individual evidence-based exercise and education programs, or a traditionally implemented exercise program.

Condition	Intervention
Low Back Pain	Behavioral: Traditional military training Behavioral: Core stabilization military training Behavioral: Psychosocial education military training Behavioral: Combined military training

MedlinePlus related topics: Back Pain Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Prevention of Low Back Pain in the Military. A Randomized Clinical Trial

Further study details as provided by University of Florida:

Primary Outcome Measures:

Episodes of low back pain [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Duration of low back pain [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Severity of low back pain [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Muscle function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Beliefs about low back pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	2700
Study Start Date:	February 2007
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Core stabilization and psychosocial education	Behavioral: Combined military training Includes both core stabilization training and psychosocial education class
2: Active Comparator Core stabilization exercise only	Behavioral: Core stabilization military training Core stabilization exercise
3: Active Comparator Psychosocial education class only.	Behavioral: Psychosocial education military training Psychosocial education class
4: No Intervention Traditional Army training	Behavioral: Traditional military training As usual training for Soldiers

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Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ages 18 - 35 years old (or emancipated minor)
Participating in 91 W (combat medic) MOS training
English speaking and reading

Exclusion Criteria:

Currently seeking medical care for LBP
Previous medical history that includes any surgery for LBP (examples include but are not limited to lumbar fusion, lumbar decompression, and lumbar discectomy)
History of degenerative joint disease, arthritis, spine trauma or vertebral fractures, spondylolisthesis, and congenital spine disorders
Currently unable to participate in AIT due to injury in foot, ankle, knee, hip, neck, shoulder, elbow, wrist, or hand injury.
History of fracture (stress or traumatic) in proximal femur and/or pelvis
Pregnancy (Note: Pregnancy will not result in termination from the study, even though it is an exclusion criteria at enrollment.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373009

Locations

United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234

Sponsors and Collaborators

University of Florida

Brooke Army Medical Center

Investigators

Principal Investigator:

Steven Z George, PT, PHD

University of Florida

More Information

Publications indexed to this study:

George SZ, Childs JD, Teyhen DS, Wu SS, Wright AC, Dugan JL, Robinson ME. Rationale, design, and protocol for the prevention of low back pain in the military (POLM) trial (NCT00373009). BMC Musculoskelet Disord. 2007 Sep 14;8:92.

Responsible Party:	University of Florida ( Steven George )
Study ID Numbers:	PR054098
Study First Received:	September 5, 2006
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00373009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:

Low back pain
Primary prevention
Secondary prevention
Lumbar stabilization
Psychosocial education

Study placed in the following topic categories:

Signs and Symptoms
Neoplasm Metastasis
Neurologic Manifestations

Low Back Pain
Pain
Back Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009