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Prevention of Low Back Pain in the Military (POLM)

This study has been completed.
Sponsor:
Collaborator:
Brooke Army Medical Center
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00373009
First received: September 5, 2006
Last updated: March 12, 2015
Last verified: March 2015
September 5, 2006
March 12, 2015
February 2007
May 2011   (Final data collection date for primary outcome measure)
  • 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 ]
  • Episodes of low back pain
  • Duration of low back pain
  • Severity of low back pain
Complete list of historical versions of study NCT00373009 on ClinicalTrials.gov Archive Site
  • Muscle function [ Time Frame: 12 weeks ]
  • Beliefs about low back pain [ Time Frame: 12 weeks ]
  • Muscle function
  • Beliefs about low back pain
Not Provided
Not Provided
 
Prevention of Low Back Pain in the Military
Prevention of Low Back Pain in the Military. A Randomized Clinical Trial
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.

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).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Low Back Pain
  • Behavioral: Traditional Army training
    As usual training for Soldiers
  • Behavioral: Core stabilization exercise only
    Core stabilization exercise
  • Behavioral: Psychosocial education class only
    Psychosocial education class
  • Behavioral: Core stabilization and psychosocial education
    Includes both core stabilization training and psychosocial education class
  • 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.
    Intervention: Behavioral: Core stabilization and psychosocial education
  • Active Comparator: Core stabilization exercise only
    A core stabilization exercise program (CSEP) is used in this group and has sound biomechanical and anatomical rationale.
    Intervention: Behavioral: Core stabilization exercise only
  • Active Comparator: Psychosocial education class only.
    A psychosocial education program (PSEP) will be used in this group.
    Intervention: Behavioral: Psychosocial education class only
  • Traditional Army training
    Traditional Army training will be used in this group.
    Intervention: Behavioral: Traditional Army training

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4325
May 2011
May 2011   (Final data collection date for primary outcome measure)

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.)
Sexes Eligible for Study: All
18 Years to 35 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00373009
PR054098
Yes
Not Provided
Not Provided
University of Florida
University of Florida
Brooke Army Medical Center
Principal Investigator: Steven Z George, PT, PHD University of Florida
University of Florida
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP