Prevention of Low Back Pain in the Military (POLM)

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ClinicalTrials.gov Identifier: NCT00373009

Recruitment Status : Completed

First Posted : September 7, 2006

Last Update Posted : March 17, 2015

Sponsor:

Collaborator:

Brooke Army Medical Center

Information provided by (Responsible Party):

University of Florida

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Low Back Pain	Behavioral: Traditional Army training Behavioral: Core stabilization exercise only Behavioral: Psychosocial education class only Behavioral: Core stabilization and psychosocial education	Not Applicable

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	4325 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Prevention of Low Back Pain in the Military. A Randomized Clinical Trial
Study Start Date :	February 2007
Actual Primary Completion Date :	May 2011
Actual Study Completion Date :	May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Core stabilization and psychosocial education A core stabilization exercise program (CSEP) is used in this group and has sound biomechanical and anatomical rationale. In addition, a psychosocial education program (PSEP) will be used for this group.	Behavioral: Core stabilization and psychosocial education Includes both core stabilization training and psychosocial education class
Active Comparator: Core stabilization exercise only A core stabilization exercise program (CSEP) is used in this group and has sound biomechanical and anatomical rationale.	Behavioral: Core stabilization exercise only Core stabilization exercise
Active Comparator: Psychosocial education class only. A psychosocial education program (PSEP) will be used in this group.	Behavioral: Psychosocial education class only Psychosocial education class
Traditional Army training Traditional Army training will be used in this group.	Behavioral: Traditional Army training As usual training for Soldiers

Outcome Measures

Primary Outcome Measures :

Episodes of low back pain [ Time Frame: 2 years ]
Duration of low back pain [ Time Frame: 2 years ]
Severity of low back pain [ Time Frame: 2 years ]

Secondary Outcome Measures :

Muscle function [ Time Frame: 12 weeks ]
Beliefs about low back pain [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 35 Years (Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373009

Locations

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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

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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 of Results:

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;9:128. doi: 10.1186/1741-7015-9-128.

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. doi: 10.1186/1471-2474-12-132.

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. doi: 10.2522/ptj.20090389. 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. doi: 10.1249/MSS.0b013e3181a84db2.

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. doi: 10.1007/s00586-009-1016-7. Epub 2009 May 6.

Other Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Childs JD, Wu SS, Andrade RL, Bonner VE, Bowman JA, Butler AM, Teyhen DS, George SZ. Incremental Effects of Telephone Call Center and Healthcare Utilization Database Use to Improve Follow-up Rate in the Prevention of Low Back Pain in the Military Trial. US Army Med Dep J. 2015 Oct-Dec:24-30.

Childs JD, Wu SS, Teyhen DS, Robinson ME, George SZ. Prevention of low back pain in the military cluster randomized trial: effects of brief psychosocial education on total and low back pain-related health care costs. Spine J. 2014 Apr;14(4):571-83. doi: 10.1016/j.spinee.2013.03.019. Epub 2013 Apr 19.

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Responsible Party:	University of Florida
ClinicalTrials.gov Identifier:	NCT00373009 History of Changes
Other Study ID Numbers:	PR054098
First Posted:	September 7, 2006 Key Record Dates
Last Update Posted:	March 17, 2015
Last Verified:	March 2015

Keywords provided by University of Florida:


Low back pain Primary prevention Secondary prevention Lumbar stabilization Psychosocial education

Additional relevant MeSH terms:

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Back Pain Low Back Pain Pain Neurologic Manifestations Signs and Symptoms

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