Prevention of Low Back Pain in the Military
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

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).
    

Intervention name(s): Traditional Army training; Core stabilization exercise only; Psychosocial education class only; Core stabilization and psychosocial education
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): As usual training for Soldiers; Core stabilization exercise; Psychosocial education class; Includes both core stabilization training and psychosocial education class
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Low back pain; Primary prevention; Secondary prevention; Lumbar stabilization; Psychosocial education