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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

Tracking Information
First Submitted Date  ICMJE September 5, 2006
First Posted Date  ICMJE September 7, 2006
Last Update Posted Date March 17, 2015
Study Start Date  ICMJE February 2007
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 5, 2006)
  • Episodes of low back pain
  • Duration of low back pain
  • Severity of low back pain
Change History Complete list of historical versions of study NCT00373009 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2008)
  • Muscle function [ Time Frame: 12 weeks ]
  • Beliefs about low back pain [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2006)
  • Muscle function
  • Beliefs about low back pain
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Low Back Pain in the Military
Official Title  ICMJE Prevention of Low Back Pain in the Military. A Randomized Clinical Trial
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2011)
4325
Original Enrollment  ICMJE
 (submitted: September 5, 2006)
2700
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00373009
Other Study ID Numbers  ICMJE PR054098
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Brooke Army Medical Center
Investigators  ICMJE
Principal Investigator: Steven Z George, PT, PHD University of Florida
PRS Account University of Florida
Verification Date March 2015

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