Prevention of Low Back Pain in the Military (POLM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00373009|
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : March 17, 2015
|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|
Hide 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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||4325 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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 ]
- Muscle function [ Time Frame: 12 weeks ]
- Beliefs about low back pain [ Time Frame: 12 weeks ]
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
|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|
|Principal Investigator:||Steven Z George, PT, PHD||University of Florida|