Low Back PainPOLMNCT00373009
Prevention of Low Back Pain in the Military
A study testing Traditional Army training, Core stabilization exercise only and Psychosocial education class only in people with Low Back Pain, run by University of Florida at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Traditional Army training, Core stabilization exercise only and Psychosocial education class only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,325 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2007to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages 18 - 35 years old (or emancipated minor)
- Participating in 91 W (combat medic) MOS training
- English speaking and reading
Who cannot join
- 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.)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
University of Florida
Gainesville, Florida, 32610
About this study
Official title: 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.
Read the 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).
- Conditions
- Low Back Pain
- Being tested
- Traditional Army training, Core stabilization exercise only, Psychosocial education class only, Core stabilization and psychosocial education
- Keywords
- Low back pain, Primary prevention, Secondary prevention, Lumbar stabilization, Psychosocial education
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Army trainingBehavioural
As usual training for Soldiers
Core stabilization exercise onlyBehavioural
Core stabilization exercise
Psychosocial education class onlyBehavioural
Psychosocial education class
Core stabilization and psychosocial educationBehavioural
Includes both core stabilization training and psychosocial education class
| Study group | Role | What they receive |
|---|---|---|
| Core stabilization and psychosocial education | Experimental | 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. Receives: Behavioral: Core stabilization and psychosocial education |
| Core stabilization exercise only | Active comparator | A core stabilization exercise program (CSEP) is used in this group and has sound biomechanical and anatomical rationale. Receives: Behavioral: Core stabilization exercise only |
| Psychosocial education class only. | Active comparator | A psychosocial education program (PSEP) will be used in this group. Receives: Behavioral: Psychosocial education class only |
| Traditional Army training | Other | Traditional Army training will be used in this group. Receives: Behavioral: Traditional Army training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodes of low back pain
Measured: 2 years
Duration of low back pain
Measured: 2 years
Severity of low back pain
Measured: 2 years
Secondary outcomes (2)
Muscle function
Measured: 12 weeks
Beliefs about low back pain
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startFeb 2007
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,325 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Brooke Army Medical Center
- Responsible party
- Sponsor
- Investigators
- Steven Z George, PT, PHD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373009
- Sponsor's protocol ID
- PR054098
- Acronym
- POLM
- Status last verified
- Mar 2015
- First submitted
- 5 Sep 2006
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
George SZ, Childs JD, Teyhen DS, Wu SS, Wright AC, Dugan JL, Robinson ME. Rationale, design, and protocol for the prevention of low back pain in the military (POLM) trial (NCT00373009). BMC Musculoskelet Disord. 2007 Sep 14;8:92. doi: 10.1186/1471-2474-8-92.
PubMed 17868436George SZ, Childs JD, Teyhen DS, Wu SS, Wright AC, Dugan JL, Robinson ME. Brief psychosocial education, not core stabilization, reduced incidence of low back pain: results from the Prevention of Low Back Pain in the Military (POLM) cluster randomized trial. BMC Med. 2011 Nov 29;9:128. doi: 10.1186/1741-7015-9-128.
PubMed 22126534Childs JD, Teyhen DS, Van Wyngaarden JJ, Dougherty BF, Ladislas BJ, Helton GL, Robinson ME, Wu SS, George SZ. Predictors of web-based follow-up response in the Prevention Of Low Back Pain In The Military Trial (POLM). BMC Musculoskelet Disord. 2011 Jun 13;12:132. doi: 10.1186/1471-2474-12-132.
PubMed 21668961Teyhen DS, George SZ, Dugan JL, Williamson J, Neilson BD, Childs JD. Inter-rater reliability of ultrasound imaging of the trunk musculature among novice raters. J Ultrasound Med. 2011 Mar;30(3):347-56. doi: 10.7863/jum.2011.30.3.347.
PubMed 21357556Childs JD, Teyhen DS, Casey PR, McCoy-Singh KA, Feldtmann AW, Wright AC, Dugan JL, Wu SS, George SZ. Effects of traditional sit-up training versus core stabilization exercises on short-term musculoskeletal injuries in US Army soldiers: a cluster randomized trial. Phys Ther. 2010 Oct;90(10):1404-12. doi: 10.2522/ptj.20090389. Epub 2010 Jul 22.
PubMed 20651013Childs JD, Teyhen DS, Benedict TM, Morris JB, Fortenberry AD, McQueen RM, Preston JB, Wright AC, Dugan JL, George SZ. Effects of sit-up training versus core stabilization exercises on sit-up performance. Med Sci Sports Exerc. 2009 Nov;41(11):2072-83. doi: 10.1249/MSS.0b013e3181a84db2.
PubMed 19812508Robinson ME, Teyhen DS, Wu SS, Dugan JL, Wright AC, Childs JD, Yang G, George SZ. Mental health symptoms in combat medic training: a longitudinal examination. Mil Med. 2009 Jun;174(6):572-7. doi: 10.7205/milmed-d-02-4108.
PubMed 19585767George SZ, Teyhen DS, Wu SS, Wright AC, Dugan JL, Yang G, Robinson ME, Childs JD. Psychosocial education improves low back pain beliefs: results from a cluster randomized clinical trial (NCT00373009) in a primary prevention setting. Eur Spine J. 2009 Jul;18(7):1050-8. doi: 10.1007/s00586-009-1016-7. Epub 2009 May 6.
PubMed 19418075Childs JD, Wu SS, Andrade RL, Bonner VE, Bowman JA, Butler AM, Teyhen DS, George SZ. Incremental Effects of Telephone Call Center and Healthcare Utilization Database Use to Improve Follow-up Rate in the Prevention of Low Back Pain in the Military Trial. US Army Med Dep J. 2015 Oct-Dec:24-30.
PubMed 26606405Childs JD, Wu SS, Teyhen DS, Robinson ME, George SZ. Prevention of low back pain in the military cluster randomized trial: effects of brief psychosocial education on total and low back pain-related health care costs. Spine J. 2014 Apr;14(4):571-83. doi: 10.1016/j.spinee.2013.03.019. Epub 2013 Apr 19.
PubMed 23608562
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Low Back Pain in the Military. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00373009
- Acronym / sponsor ID
- POLM / PR054098
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Primary prevention, Secondary prevention, Lumbar stabilization, Psychosocial education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,325 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Brooke Army Medical Center
- Study start
- Feb 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Core stabilization and psychosocial education | Experimental | Behavioral: Core stabilization and psychosocial educationA 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. |
| Core stabilization exercise only | Active comparator | Behavioral: Core stabilization exercise onlyA core stabilization exercise program (CSEP) is used in this group and has sound biomechanical and anatomical rationale. |
| Psychosocial education class only. | Active comparator | Behavioral: Psychosocial education class onlyA psychosocial education program (PSEP) will be used in this group. |
| Traditional Army training | Other | Behavioral: Traditional Army trainingTraditional Army training will be used in this group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ages 18 - 35 years old (or emancipated minor)
- Participating in 91 W (combat medic) MOS training
- English speaking and reading
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Army trainingAs usual training for Soldiers | Behavioural | Traditional Army training |
| Core stabilization exercise onlyCore stabilization exercise | Behavioural | Core stabilization exercise only |
| Psychosocial education class onlyPsychosocial education class | Behavioural | Psychosocial education class only. |
| Core stabilization and psychosocial educationIncludes both core stabilization training and psychosocial education class | Behavioural | Core stabilization and psychosocial education |
Primary outcome
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
2 secondary outcomes
Muscle function
Time frame: 12 weeks
Beliefs about low back pain
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
- Background: PubMed 17868436George SZ, Childs JD, Teyhen DS, Wu SS, Wright AC, Dugan JL, Robinson ME. Rationale, design, and protocol for the prevention of low back pain in the military (POLM) trial (NCT00373009). BMC Musculoskelet Disord. 2007 Sep 14;8:92. doi: 10.1186/1471-2474-8-92.
- Results publication: PubMed 22126534George SZ, Childs JD, Teyhen DS, Wu SS, Wright AC, Dugan JL, Robinson ME. Brief psychosocial education, not core stabilization, reduced incidence of low back pain: results from the Prevention of Low Back Pain in the Military (POLM) cluster randomized trial. BMC Med. 2011 Nov 29;9:128. doi: 10.1186/1741-7015-9-128.
- Results publication: PubMed 21668961Childs JD, Teyhen DS, Van Wyngaarden JJ, Dougherty BF, Ladislas BJ, Helton GL, Robinson ME, Wu SS, George SZ. Predictors of web-based follow-up response in the Prevention Of Low Back Pain In The Military Trial (POLM). BMC Musculoskelet Disord. 2011 Jun 13;12:132. doi: 10.1186/1471-2474-12-132.
- Results publication: PubMed 21357556Teyhen DS, George SZ, Dugan JL, Williamson J, Neilson BD, Childs JD. Inter-rater reliability of ultrasound imaging of the trunk musculature among novice raters. J Ultrasound Med. 2011 Mar;30(3):347-56. doi: 10.7863/jum.2011.30.3.347.
- Results publication: PubMed 20651013Childs JD, Teyhen DS, Casey PR, McCoy-Singh KA, Feldtmann AW, Wright AC, Dugan JL, Wu SS, George SZ. Effects of traditional sit-up training versus core stabilization exercises on short-term musculoskeletal injuries in US Army soldiers: a cluster randomized trial. Phys Ther. 2010 Oct;90(10):1404-12. doi: 10.2522/ptj.20090389. Epub 2010 Jul 22.
- Results publication: PubMed 19812508Childs JD, Teyhen DS, Benedict TM, Morris JB, Fortenberry AD, McQueen RM, Preston JB, Wright AC, Dugan JL, George SZ. Effects of sit-up training versus core stabilization exercises on sit-up performance. Med Sci Sports Exerc. 2009 Nov;41(11):2072-83. doi: 10.1249/MSS.0b013e3181a84db2.
- Results publication: PubMed 19585767Robinson ME, Teyhen DS, Wu SS, Dugan JL, Wright AC, Childs JD, Yang G, George SZ. Mental health symptoms in combat medic training: a longitudinal examination. Mil Med. 2009 Jun;174(6):572-7. doi: 10.7205/milmed-d-02-4108.
- Results publication: PubMed 19418075George SZ, Teyhen DS, Wu SS, Wright AC, Dugan JL, Yang G, Robinson ME, Childs JD. Psychosocial education improves low back pain beliefs: results from a cluster randomized clinical trial (NCT00373009) in a primary prevention setting. Eur Spine J. 2009 Jul;18(7):1050-8. doi: 10.1007/s00586-009-1016-7. Epub 2009 May 6.
- Derived from this study: PubMed 26606405Childs JD, Wu SS, Andrade RL, Bonner VE, Bowman JA, Butler AM, Teyhen DS, George SZ. Incremental Effects of Telephone Call Center and Healthcare Utilization Database Use to Improve Follow-up Rate in the Prevention of Low Back Pain in the Military Trial. US Army Med Dep J. 2015 Oct-Dec:24-30.
- Derived from this study: PubMed 23608562Childs JD, Wu SS, Teyhen DS, Robinson ME, George SZ. Prevention of low back pain in the military cluster randomized trial: effects of brief psychosocial education on total and low back pain-related health care costs. Spine J. 2014 Apr;14(4):571-83. doi: 10.1016/j.spinee.2013.03.019. Epub 2013 Apr 19.
- Link to abstract and paper for primary study resultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Z George, PT, PHD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Army training, Core stabilization exercise only and Psychosocial education class only in people with Low Back Pain, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Episodes of low back pain (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00373009, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.