Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373009
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2006-09-05
Brief Title:
Prevention of Low Back Pain in the Military
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Prevention of Low Back Pain in the Military A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POLM
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 150000 active duty Soldiers annually MSMR 2003 Soldiers in the US 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 occurs8 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 occur9 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 CSEPPSEP We will compare the preventative effects of these exercise and education programs to an already implemented traditional exercise program TEP
ObjectiveHypothesis 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 US Armed Forces by improving the readiness of their Soldiers reducing economic burden and limiting disability among Soldiers For example an average cost of 13602 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 3343230 by the 4th fiscal year approximately 15 of the total cost of LBP for one FY
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 occurs8 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 occur9 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 CSEPPSEP We will compare the preventative effects of these exercise and education programs to an already implemented traditional exercise program TEP
ObjectiveHypothesis 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 US Armed Forces by improving the readiness of their Soldiers reducing economic burden and limiting disability among Soldiers For example an average cost of 13602 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 3343230 by the 4th fiscal year approximately 15 of the total cost of LBP for one FY
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None