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Prevention of Low Back Pain in the Military (POLM)

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Traditional Army training
Core stabilization exercise only
Psychosocial education class only
Core stabilization and psychosocial education
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Low Back Pain focused on measuring Low back pain, Primary prevention, Secondary prevention, Lumbar stabilization, Psychosocial education

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • University of Florida
  • Brooke Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Other

Arm Label

Core stabilization and psychosocial education

Core stabilization exercise only

Psychosocial education class only.

Traditional Army training

Arm Description

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.

A core stabilization exercise program (CSEP) is used in this group and has sound biomechanical and anatomical rationale.

A psychosocial education program (PSEP) will be used in this group.

Traditional Army training will be used in this group.

Outcomes

Primary Outcome Measures

Episodes of low back pain
Duration of low back pain
Severity of low back pain

Secondary Outcome Measures

Muscle function
Beliefs about low back pain

Full Information

First Posted
September 5, 2006
Last Updated
March 12, 2015
Sponsor
University of Florida
Collaborators
Brooke Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00373009
Brief Title
Prevention of Low Back Pain in the Military
Acronym
POLM
Official Title
Prevention of Low Back Pain in the Military. A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Brooke Army Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.
Detailed Description
Background: Low back pain (LBP) is a musculoskeletal condition that accounts for significant pain and disability, and consumes substantial medical and occupational costs annually. Specific to the United States Armed Forces, LBP was the second most common reason to seek healthcare and affects over 150,000 active duty Soldiers annually (MSMR 2003). Soldiers in the U.S. Army with LBP have the highest risk of disability 5 years after their injury. Furthermore, a military review suggests that LBP was the most common condition bringing about a medical board, with lifetime direct compensation costs estimated to reach into the billions of dollars. Therefore, reduction of disability from LBP is a significant research priority for the military. Reduction of disability from LBP has been divided into 2 separate phases - primary and secondary prevention. Primary prevention refers to interventions and strategies that are implemented before a low back injury occurs.8 Primary prevention reduces LBP related disability by reducing the total number of people who eventually experience an episode of LBP. Secondary prevention refers to interventions and strategies that are implemented during the acute episode of low back injury, before chronic symptoms occur.9 Secondary prevention reduces LBP related disability by reducing the number of people who eventually experience chronic disability from LBP. We are proposing an innovative approach to LBP prevention by combining primary and secondary prevention strategies that have the potential to limit the development of chronic LBP in Soldiers. The primary prevention strategy is a core stabilization exercise program (CSEP). The CSEP used in this study has sound biomechanical and anatomical rationale, and has demonstrated its clinical efficacy by preventing future recurrence of LBP. However, this CSEP has not been previously investigated for primary prevention of LBP in healthy Soldiers. The secondary prevention strategy is a psychosocial education program (PSEP). The PSEP used in this study has sound theoretical rationale. It has also demonstrated its clinical efficacy by favorably altering LBP beliefs, as well as limiting the eventual severity of LBP episodes. These programs (individually or in combination) have not been investigated for prevention of chronic LBP in healthy Soldiers. Therefore, we will train healthy Soldiers in the United States Army in CSEP, PSEP, or combined CSEP/PSEP. We will compare the preventative effects of these exercise and education programs to an already implemented traditional exercise program (TEP). Objective/Hypothesis: The purpose of this study is to determine if a combined prevention program is more effective at limiting the development of chronic LBP when compared to the effects of individual evidence-based prevention programs, or a traditional exercise program Specific Aims Specific Aim 1: We will determine if a combined prevention program consisting of CSEP and PSEP prevents the development of chronic LBP. During advanced individual training (AIT), United States Army Soldiers will be randomly assigned to receive 1 of 4 prevention programs. Soldiers will be followed monthly to measure LBP occurrence and severity during 2 years of active duty with a web-based data collection system managed at the University of Florida. Specific Aim 2: We will determine if the CSEP results in favorable changes in specific core musculature associated with reducing LBP. The CSEP activates specific core musculature that are important in preventing LBP. We will use real-time ultrasound imaging to document changes in core musculature that occur during AIT. We will also determine if the PSEP results in a favorable change in LBP beliefs. The PSEP educates individuals in an evidence-based, psychosocial approach to the management of LBP, which decreases the likelihood of experiencing chronic LBP. We will use a validated self-report questionnaire to measure Soldiers' LBP beliefs regarding outcome and management. We will measure LBP beliefs before and after AIT (a 12-week period). Study Design: Cluster randomized clinical trial. Twelve companies of Soldiers (n = 2700) reporting to advanced individual training for the 91 W military occupational specialty training will be randomly assigned to CSEP and PSEP (combined education and exercise prevention program), CSEP (exercise prevention program), PSEP and TEP (educational prevention program), and TEP (standard physical training). Relevance: The results of this study will have several immediate applications for Soldiers. The widespread incorporation of effective preventative strategies will certainly result in a substantial reduction of LBP in the military. Programs that effectively prevent the occurrence and severity of LBP would benefit the U.S. Armed Forces by improving the readiness of their Soldiers, reducing economic burden, and limiting disability among Soldiers. For example, an average cost of $136.02 per LBP visit was calculated for 2004. A 40% reduction in the recurrence of LBP after completing the CSEP would generate a cost savings of $3,343,230 by the 4th fiscal year (approximately 1/5 of the total cost of LBP for one FY).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Primary prevention, Secondary prevention, Lumbar stabilization, Psychosocial education

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4325 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Core stabilization and psychosocial education
Arm Type
Experimental
Arm Description
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.
Arm Title
Core stabilization exercise only
Arm Type
Active Comparator
Arm Description
A core stabilization exercise program (CSEP) is used in this group and has sound biomechanical and anatomical rationale.
Arm Title
Psychosocial education class only.
Arm Type
Active Comparator
Arm Description
A psychosocial education program (PSEP) will be used in this group.
Arm Title
Traditional Army training
Arm Type
Other
Arm Description
Traditional Army training will be used in this group.
Intervention Type
Behavioral
Intervention Name(s)
Traditional Army training
Intervention Description
As usual training for Soldiers
Intervention Type
Behavioral
Intervention Name(s)
Core stabilization exercise only
Intervention Description
Core stabilization exercise
Intervention Type
Behavioral
Intervention Name(s)
Psychosocial education class only
Intervention Description
Psychosocial education class
Intervention Type
Behavioral
Intervention Name(s)
Core stabilization and psychosocial education
Intervention Description
Includes both core stabilization training and psychosocial education class
Primary Outcome Measure Information:
Title
Episodes of low back pain
Time Frame
2 years
Title
Duration of low back pain
Time Frame
2 years
Title
Severity of low back pain
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Muscle function
Time Frame
12 weeks
Title
Beliefs about low back pain
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Z George, PT, PHD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17868436
Citation
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. doi: 10.1186/1471-2474-8-92.
Results Reference
background
PubMed Identifier
22126534
Citation
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.
Results Reference
result
PubMed Identifier
21668961
Citation
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.
Results Reference
result
PubMed Identifier
21357556
Citation
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. doi: 10.7863/jum.2011.30.3.347.
Results Reference
result
PubMed Identifier
20651013
Citation
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.
Results Reference
result
PubMed Identifier
19812508
Citation
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.
Results Reference
result
PubMed Identifier
19585767
Citation
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. doi: 10.7205/milmed-d-02-4108. Erratum In: Mil Med. 2009 Dec;174(12):1294.
Results Reference
result
PubMed Identifier
19418075
Citation
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.
Results Reference
result
PubMed Identifier
26606405
Citation
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.
Results Reference
derived
PubMed Identifier
23608562
Citation
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.
Results Reference
derived
Links:
URL
http://www.biomedcentral.com/1741-7015/9/128/abstract
Description
Link to abstract and paper for primary study results

Learn more about this trial

Prevention of Low Back Pain in the Military

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