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

Sponsor:	University of Florida
Collaborator:	Brooke Army Medical Center
Information provided by (Responsible Party):	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Prevention of Low Back Pain in the Military. A Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Exercise and Physical Fitness

U.S. FDA Resources

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 ]

Enrollment:	4325
Study Start Date:	February 2007
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

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

Show Detailed Description

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

Additional Information:

Link to abstract and paper for primary study results This link exits the ClinicalTrials.gov site

Publications:

George SZ, Childs JD, Teyhen DS, Wu SS, Wright AC, Dugan JL, Robinson ME. Brief psychosocial education, not core stabilization, reduced incidence of low back pain: results from the Prevention of Low Back Pain in the Military (POLM) cluster randomized trial. BMC Med. 2011 Nov 29;9(1):128 [Epub ahead of print]

Childs JD, Teyhen DS, Van Wyngaarden JJ, Dougherty BF, Ladislas BJ, Helton GL, Robinson ME, Wu SS, George SZ. Predictors of web-based follow-up response in the Prevention Of Low Back Pain In The Military Trial (POLM). BMC Musculoskelet Disord. 2011 Jun 13;12:132.

Teyhen DS, George SZ, Dugan JL, Williamson J, Neilson BD, Childs JD. Inter-rater reliability of ultrasound imaging of the trunk musculature among novice raters. J Ultrasound Med. 2011 Mar;30(3):347-56.

Childs JD, Teyhen DS, Casey PR, McCoy-Singh KA, Feldtmann AW, Wright AC, Dugan JL, Wu SS, George SZ. Effects of traditional sit-up training versus core stabilization exercises on short-term musculoskeletal injuries in US Army soldiers: a cluster randomized trial. Phys Ther. 2010 Oct;90(10):1404-12. Epub 2010 Jul 22.

Childs JD, Teyhen DS, Benedict TM, Morris JB, Fortenberry AD, McQueen RM, Preston JB, Wright AC, Dugan JL, George SZ. Effects of sit-up training versus core stabilization exercises on sit-up performance. Med Sci Sports Exerc. 2009 Nov;41(11):2072-83.

Robinson ME, Teyhen DS, Wu SS, Dugan JL, Wright AC, Childs JD, Yang G, George SZ. Mental health symptoms in combat medic training: a longitudinal examination. Mil Med. 2009 Jun;174(6):572-7. Erratum in: Mil Med. 2009 Dec;174(12):1294.

George SZ, Teyhen DS, Wu SS, Wright AC, Dugan JL, Yang G, Robinson ME, Childs JD. Psychosocial education improves low back pain beliefs: results from a cluster randomized clinical trial (NCT00373009) in a primary prevention setting. Eur Spine J. 2009 Jul;18(7):1050-8. Epub 2009 May 6.

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
ClinicalTrials.gov Identifier:	NCT00373009 History of Changes
Other Study ID Numbers:	PR054098
Study First Received:	September 5, 2006
Last Updated:	December 21, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:

Low back pain
Primary prevention
Secondary prevention
Lumbar stabilization
Psychosocial education

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012