Group Title: BMC Musculoskeletal Disorders
Title: Rationale, design, and protocol for the prevention of low back pain in the military (POLM) trial (NCT00373009)
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Title: Rationale, design, and protocol for the prevention of low back pain in the military (POLM) trial (NCT00373009)
Physical Description: Book
Language: English
Creator: George, Steven
Childs, John
Teyhen, Deydre
Wu, Samuel
Wright, Alison
Dugan, Jessica
Robinson, Michael
Publisher: BMC Musculoskeletal Disorders
Publication Date: 2007
 Notes
Abstract: BACKGROUND:There are few effective strategies reported for the primary prevention of low back pain (LBP). Core stabilization exercises targeting the deep abdominal and trunk musculature and psychosocial education programs addressing patient beliefs and coping styles represent the current best evidence for secondary prevention of low back pain. However, these programs have not been widely tested to determine if they are effective at preventing the primary onset and/or severity of LBP. The purpose of this cluster randomized clinical trial is to determine if a combined core stabilization exercise and education program is effective in preventing the onset and/or severity of LBP. The effect of the combined program will be compared to three other standard programs.METHODS/DESIGN:Consecutive Soldiers participating in advanced individual training (AIT) will be screened for eligibility requirements and consented to study participation, as appropriate. Companies of Soldiers will be randomly assigned to receive the following standard prevention programs; a core stabilization exercise program (CSEP) alone, a CSEP with a psychosocial education (PSEP), a traditional exercise (TEP), or a TEP with a PSEP. Proximal outcome measures will be assessed at the conclusion of AIT (a 12 week training period) and include imaging of deep lumbar musculature using real-time ultrasound imaging and beliefs about LBP by self-report questionnaire. We are hypothesizing that Soldiers receiving the CSEP will have improved thickness of selected deep lumbar musculature (transversus abdominus, multifidi, and erector spinae muscles). We are also hypothesizing that Soldiers receiving the PSEP will have improved beliefs about the management of LBP. After AIT, Soldiers will be followed monthly to measure the distal outcomes of LBP occurrence and severity. This information will be collected during the subsequent 2 years following completion of AIT using a web-based data entry system. Soldiers will receive a monthly email that queries whether any LBP was experienced in the previous calendar month. Soldiers reporting LBP will enter episode-specific data related to pain intensity, pain-related disability, fear-avoidance beliefs, and pain catastrophizing. We are hypothesizing that Soldiers receiving the CSEP and PSEP will report the longest duration to first episode of LBP, the lowest frequency of LBP, and the lowest severity of LBP episodes. Statistical comparisons will be made between each of the randomly assigned prevention programs to test our hypotheses related to determining which of the 4 programs is most effective.DISCUSSION:We have presented the design and protocol for the POLM trial. Completion of this trial will provide important information on how to effectively train Soldiers for the prevention of LBP.TRIAL REGISTRATION:NCT00373009
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Study protocol


Rationale, design, and protocol for the prevention of low back pain
in the military (POLM) trial (NCT00373009)
Steven Z George* 1, John D Childs2, Deydre S Teyhen2, Samuel S Wu3,
Alison C Wright2, Jessica L Dugan2 and Michael E Robinson4


Address: 'Department of Physical Therapy, Brooks Center for Rehabilitation Studies, PO Box 100154, University of Florida, Gainesville, FL, 32610-
0154, USA, 2US Army-Baylor University Doctoral Program in Physical Therapy (MCCS-HMT), Army Medical Department Center and School, 3151
Scott Rd., Rm. 2307, Fort Sam Houston, TX 78234, USA, 3Department of Epidemiology and Health Policy Research, PO Box 100177, University
of Florida, Gainesville, FL 32610-0177, USA and 4Department of Clinical and Health Psychology, Center for Pain Research and Behavioral Health,
University of Florida, Gainesville, FL 32610-0165, USA
Email: Steven Z George* sgeorge@phhp.ufl.edu; John D Childs childsjd@sbcglobal.net; Deydre S Teyhen dteyhen@sbcglobal.net;
Samuel S Wu samwu@biostat.ufl.edu; Alison C Wright alison.wright@us.army.mil; Jessica L Dugan jessie@evidenceinmotion.com;
Michael E Robinson merobin@ufl.edu
* Corresponding author



Published: 14 September 2007 Received: 8 May 2007
BMCMusculoskeletal Disorders 2007, 8:92 doi:10.1 186/1471-2474-8-92 Accepted: 14 September 2007
This article is available from: http://www.biomedcentral.com/1471-2474/8/92
2007 George et al; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0),
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.



Abstract
Background: There are few effective strategies reported for the primary prevention of low back
pain (LBP). Core stabilization exercises targeting the deep abdominal and trunk musculature and
psychosocial education programs addressing patient beliefs and coping styles represent the current
best evidence for secondary prevention of low back pain. However, these programs have not been
widely tested to determine if they are effective at preventing the primary onset and/or severity of
LBP. The purpose of this cluster randomized clinical trial is to determine if a combined core
stabilization exercise and education program is effective in preventing the onset and/or severity of
LBP. The effect of the combined program will be compared to three other standard programs.
Methods/Design: Consecutive Soldiers participating in advanced individual training (AIT) will be
screened for eligibility requirements and consented to study participation, as appropriate.
Companies of Soldiers will be randomly assigned to receive the following standard prevention
programs; a core stabilization exercise program (CSEP) alone, a CSEP with a psychosocial
education (PSEP), a traditional exercise (TEP), or a TEP with a PSEP. Proximal outcome measures
will be assessed at the conclusion of AIT (a 12 week training period) and include imaging of deep
lumbar musculature using real-time ultrasound imaging and beliefs about LBP by self-report
questionnaire. We are hypothesizing that Soldiers receiving the CSEP will have improved thickness
of selected deep lumbar musculature transversuss abdominus, multifidi, and erector spinae
muscles). We are also hypothesizing that Soldiers receiving the PSEP will have improved beliefs
about the management of LBP. After AIT, Soldiers will be followed monthly to measure the distal
outcomes of LBP occurrence and severity. This information will be collected during the subsequent
2 years following completion of AIT using a web-based data entry system. Soldiers will receive a
monthly email that queries whether any LBP was experienced in the previous calendar month.
Soldiers reporting LBP will enter episode-specific data related to pain intensity, pain-related
disability, fear-avoidance beliefs, and pain catastrophizing. We are hypothesizing that Soldiers
receiving the CSEP and PSEP will report the longest duration to first episode of LBP, the lowest


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frequency of LBP, and the lowest severity of LBP episodes. Statistical comparisons will be made
between each of the randomly assigned prevention programs to test our hypotheses related to
determining which of the 4 programs is most effective.
Discussion: We have presented the design and protocol for the POLM trial. Completion of this
trial will provide important information on how to effectively train Soldiers for the prevention of
LBP.
Trial registration: NCT00373009


Background
Low back pain (LBP) is one of the most common forms of
chronic pain [1,2] and is a significant cause of disability
and cost in society [3-6]. Chronic LBP substantially influ-
ences the capacity to work and has been associated with
the inability to obtain or maintain employment [5] and
lost productivity [6]. Specific to the United States military,
LBP was the second most common reason to seek health-
care and affects over 150,000 active duty Soldiers annually
[7]. Soldiers in the U.S. Army with LBP have the highest
risk of disability 5 years after their injury [8], and LBP was
the most common condition bringing about a medical
board, with lifetime direct compensation costs estimated
to reach into the billions of dollars [9]. Reduction of dis-
ability 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. Pri-
mary prevention refers to interventions and strategies that
are implemented before a low back injury occurs [10]. Pri-
mary prevention reduces LBP related disability by reduc-
ing the total number of people who eventually experience
an episode of LBP. Secondary prevention refers to inter-
ventions and strategies that are implemented during the
acute episode of low back injury, before chronic symp-
toms occur [11]. Secondary prevention reduces LBP
related disability by reducing the number of people who
eventually experience chronic disability from LBP. This
cluster randomized clinical trial incorporates a combina-
tion of primary and secondary prevention strategies for
limiting the occurrence and severity of LBP for active duty
Soldiers in the U. S. Army.

Primary prevention
Theoretically, primary prevention would be the most
effective manner to reduce disability from LBP; however,
the current scientific literature does not support com-
monly used methods. For example, randomized clinical
trials in occupational settings have demonstrated the inef-
fectiveness of commonly used primary prevention strate-
gies such as back schools, lumbar supports, and
ergonomic interventions [12,13]. Despite this lack of evi-
dence, efforts continue to investigate primary prevention


interventions because of the obvious benefits of reducing
LBP before it occurs. A recent review article suggests that
future research related to primary prevention should focus
on exercise programs, as they may offer the greatest poten-
tial for reducing disability from LBP [12]. Core stabiliza-
tion exercise programs (CSEP) may be a good choice for
primary prevention studies because biomechanical, ana-
tomical, and clinical studies provide evidence that core
stabilization is an effective intervention [14-16].

Biomechanical and anatomical evidence supporting core
stabilization
Core muscles attached to the spine such as the transversus
abdominus, multifidus, and the erector spinae play a key
supportive role that contribute to the ability of the lumbar
spine to withstand loading [17,18]. As an example, the
transversus abdominus, one of the deep abdominal mus-
cles, stabilizes the spine by forming a corset or rigid cylin-
der around the spine. Recent evidence supports a feed-
forward postural control role for the transversus abdomi-
nus as it relates to limb movement [19-23]. Hodges et al
[19-21,23] demonstrated that transverses abdominus
muscle activation occurred prior to limb movement
(regardless of directions) in asymptomatic adults. How-
ever, in patients with LBP, there is a delay in activation of
transversus abdominus contraction relative to the primary
muscles of the limb [24-26], suggesting that people with
LBP lack optimal stability of the spine prior to activities
requiring limb movements.

The multifidi are small intrinsic muscles that function as
the primary intersegmental stabilizers of the spine [17].
Poor endurance of the multifidus is a predictor of
increased recurrence of LBP. Further, multifidus atrophy
and decreased muscular activity tends to occur on the side
of symptoms [27-29]. The magnitude of atrophy has also
been linked with poor outcomes following laminectomy
surgery [30]. Furthermore, the multifidi do not automati-
cally recover full strength and endurance after the first epi-
sode of LBP unless specific rehabilitation is done [31].
Hides et al [15,27,31] demonstrated that patients with
>30% discrepancy in the cross-sectional area of the multi-
fidus muscle are at an increased risk for having recurrent
LBP unless treated with a CSEP.


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The erector spinae (longissimus thoracis and iliocostalis
lumborum) primarily produce extensor force needed for
lifting but also stabilizes the spine. McGill has shown that
the pars lumborum portions of these muscles are able to
produce significant torque moments around all three
orthopedic axes of motion [32], while Cholewicki dem-
onstrated an antagonistic co-activation of trunk flexors
and extensors occurs around the neutral spine in healthy
subjects [33]. This co-activation increased in response to
addition of an external load. In addition, Lee et al [34]
found that, in a cohort of subjects followed for five years,
the development of LBP was associated with lower levels
of extensor strength compared to flexor strength. The con-
vergence of these findings supports the need to further
examine the effectiveness of exercise programs that target
these muscles in preventing LBP.

Clinical evidence supporting core stabilization
Treatment and prevention exercise programs for LBP that
have been reported in the literature commonly involve
muscles involved in core stabilization such as the trans-
versus abdominus, multifidi, and erector spinae muscles
[15,16,351. The fundamental component of these exercise
programs is that they improve the neuromuscular activa-
tion and control of the targeted muscles. Reports in the lit-
erature have also highlighted that these programs may be
an effective way to reduce disability from LBP. For exam-
ple, a randomized clinical trial demonstrated that per-
formance of a CSEP emphasizing activation of the
transversus abdominus caused fewer recurrences of LBP 3
years following treatment for first time LBP [15]. Individ-
uals with a >30% discrepancy in the cross-sectional area of
the multifidus who completed a specific CSEP experi-
enced 50% fewer recurrences of LBP at one year and 40%
fewer recurrences at three years after treatment compared
to individuals who received standard of care medical
treatment [15].

The lack of core stabilization has been identified as a
potential predictor of an individual's risk of developing
recurrent LBP [36,37], further increasing the impetus for
incorporating CSEP into routine physical training pro-
grams across the United States Army. While these asser-
tions regarding CSEP and LBP prevention are promising,
they have not been rigorously tested in clinical trials
involving healthy Soldiers. Differences in muscle training
are important to consider because TEP training focuses on
muscles (i.e. rectus abdominus and oblique abdominals)
not consistently supported by biomechanical and ana-
tomical evidence [19,24,38,39]. In fact, a clinical trial sug-
gests that exercises included in a TEP were ineffective at
preventing LBP [40]. Therefore, it is not known if perform-
ance of CSEP effectively prevents LBP when compared to
a traditional exercise program (TEP) commonly imple-
mented in physical training.


Secondary prevention
The scientific literature has also investigated secondary
prevention as a strategy to reduce disability from LBP
because effective primary prevention strategies are cur-
rently lacking [11]. Secondary prevention strategies have
met with some success, and two consistent themes have
developed. The first theme is that psychological factors
play a significant role in the development of chronic disa-
bility from LBP. Prospective studies involving patients
with acute LBP have consistently demonstrated that when
compared to demographic or physical factors, psycholog-
ical factors are the strongest predictors of chronic disabil-
ity from LBP [41,42]. The second theme is that early
interventions that address these psychological factors
result in decreased disability from LBP [43-45].

Psychological model for the development of chronic low
back pain
Psychological models are commonly used to explain one
manner in which chronic disability develops from LBP
[46,47] and one specific model is the Fear-Avoidance
Model (FAM) [48]. This model proposed that fear-avoid-
ance beliefs and pain catastrophizing are the primary psycho-
social factors involved in the development and
maintenance of chronic symptoms. Fear-avoidance beliefs
are comprised of an individual's pain experiences, present
stress level, pain behavior, and certain personality traits
[49]. Fear-avoidance beliefs detail an individual's fear of
pain and re-injury specific to LBP and the belief as to
whether physical activity should be maintained while
experiencing LBP [49]. Pain catastrophizing is a negative,
multidimensional construct comprised of rumination,
helplessness, and pessimism cognitions [50]. Pain cata-
strophizing is related to the belief that the experienced
pain will inevitably result in the worst possible outcome
[501.

Collectively, these psychosocial factors determined the
response to an episode of LBP along a continuum from
confrontation to avoidance. A confrontation strategy (low
levels of fear-avoidance beliefs and pain catastrophizing)
is viewed as an adaptive response, enabling the individual
to return to normal vocational and social activities. An
avoidance strategy (high levels of fear-avoidance beliefs
and pain catastrophizing) is viewed as a maladaptive
response. The consequences of an avoidance strategy are
theorized to be both psychological (hyperalgesia) and
physical (chronic disability and reductions in physical
performance). Furthermore, continuation of an avoid-
ance response contributes to the pain experience in a del-
eterious manner by making it more likely to maintain
high levels of pain-related fear and pain catastrophizing.






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Clinical evidence supporting psychosocial education
programs
Fear-avoidance beliefs and pain catastrophizing were
strongly associated with pain intensity and disability in
patients with chronic LBP [51-55]. Longitudinal studies
have demonstrated that fear-avoidance beliefs and pain
catastrophizing are also precursors to the development of
chronic disability [41,56-58]. As a result, it has been
hypothesized that early reduction of fear-avoidance
beliefs and pain catastrophizing is an important way to
reduce development of chronic LBP.

Psychosocial education programs (PSEP) that reduce fear-
avoidance beliefs and pain catastrophizing have been
described in the literature [44,45,59,60]. These educa-
tional programs differ from traditional educational
approaches in that they de-emphasize the anatomical
cause of LBP (as it often cannot be determined), encour-
age the patient to take an active role in his recovery, pro-
vide evidence-based information on LBP management
and outcome, teach the patient to view back pain as a
common (i.e. not a serious disease) condition, and
instruct the individual on the importance of maintaining
positive attitude and coping styles (i.e. limiting fear-
avoidance beliefs and pain catastrophizing).

Randomized clinical trials and quasi-experimental
designs provide consistent evidence that PSEP's decrease
maladaptive beliefs and coping styles in healthy individu-
als and patients experiencing LBP [43,44,61,62]. Further-
more, early evidence from randomized clinical trials
suggests that psychological and physical LBP severity (i.e.
fear-avoidance beliefs, coping strategies, pain intensity
and/or pain-related disability) can be decreased when
PSEP's are implemented in individuals experiencing LBP
[43-45]. This evidence is promising, as it suggests that
severity of LBP can be favorably modified with a PSEP.
Although a PSEP delivered via public service announce-
ments has been investigated in healthy individuals and
found to decrease beliefs associated with LBP [62], no
research has determined if PSEPs are effective at reducing
the occurrence or severity of LBP when administered to
healthy individuals.

Summary and purpose
The accumulated evidence supports the potential of CSEP
and PSEP for prevention of LBP. Early evidence supports
the effectiveness of these combined programs for reducing
future disability in patients already experiencing LBP
[44,45]. However, the effect of early implementation (i.e.
in healthy individuals before the onset of LBP) of combin-
ing CSEP and PSEP has not been previously investigated
in a large-scale, controlled study. The purpose of the Pre-
vention of Low Back Pain in the Military (POLM) trial is
to determine if a combination of CSEP and PSEP is effec-


tive in limiting the onset of LBP and/or the severity of LBP.
The effect of this combined program will be compared to
three other standard programs.

Methods/Design
The institutional review boards at the Brooke Army Medi-
cal Center (Fort Sam Houston, Texas) and the University
of Florida (Gainesville, FL) have granted approval for this
project. Figure 1 provides an overview of the proposed
study design.

Subjects
We will be recruiting consecutive Soldiers entering the
combat medic 12-week advanced individual training
(AlT) program at Fort Sam Houston, Texas. Soldiers will
be screened for eligibility according to the following
inclusion/exclusion criteria:

Inclusion criteria
* Ages 18 (or emancipated minor that is 17 years old) -
35 years old


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Figure I
Proposed study design of the prevention of low back
pain in the military (POLM) trial. LBP, low back pain;
AIT, advanced individual training; CSEP, core stabilization
exercise program; PSEP, psychosocial education program;
TEP, traditional exercise program.


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* Participating in combat medic military occupational
specialty (MOS) training

* English speaking and reading

Exclusion criteria
* Prior history of LBP (defined as LBP that limited work or
physical activity for greater than 48 hours or caused indi-
vidual to seek healthcare)

* Currently seeking medical care for LBP

* Previous medical history including history of degenera-
tive joint disease, arthritis, spine trauma or vertebral frac-
tures, spondylolisthesis, and/or congenital spine
disorders. This also includes any prior surgery for LBP

* Currently unable to participate in unit physical training
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

* Currently pregnant (later pregnancy will not result in
termination from the study, but it is an exclusion criteria
at enrollment.)

* Have been rolled over from another Company partici-
pating in combat medic military occupational specialty
(MOS) training

Research staff at Fort Sam Houston, Texas will introduce
this study to Soldiers, screen them for eligibility, and
obtain informed consent from Soldiers, as appropriate.
The informed consent document will obtain permission
from Soldiers to perform the study-related procedures and
to contact them at their civilian address if any of the par-
ticipants have been separated or discharged from active
duty during the 2-year follow-up period. After providing
informed consent, Soldiers will be issued a card with user-
name, password, and information for accessing a secure
website hosted by the University of Florida. Subjects will
be monitored through all four stages of this trial (enroll-
ment, intervention allocation, follow-up, and data analy-
sis) in compliance with CONSORT guidelines [63]. For
example, we will record reasons for a subject dropping out
of the study during any stage of the trial and we will record
all reasons for non-participation in the study to enable
our ability to calculate an overall participation rate.

Randomization
We acknowledge the ideal study design to answer our
research question would involve individual randomiza-
tion of Soldiers to the 4 prevention programs. However,


individual randomization presents unique challenges in a
military training environment that would seriously
impede this study's feasibility. Military training environ-
ments require Soldiers to live in close quarters with other
members of their unit, to facilitate optimal training and to
foster esprit de corps. Soldiers function in teams during
many of their training activities, including unit physical
training. Specifically, we elected not to individually rand-
omize to the prevention programs because a) it would
potentially detract from unit cohesion, b) contamination
of the treatment groups would be inevitable, and c) the
administration of the study would be excessively burden-
some for drill instructors leading unit physical training.

Therefore, we will utilize a cluster randomization strategy
by randomly assigning company units, such that every
Soldier in the company who consents to participation in
the study completes the same prevention program. Clus-
ter randomization has been effectively used in other
investigations involving large samples of musculoskeletal
injury prevention, adherence to quality indicators for pre-
vention of cardiovascular disease, and the effect of a com-
munity-based intervention on maternal depression [64-
66]. The cluster randomization schedule will be deter-
mined before recruitment begins and will be balanced.

Exercise programs
The Soldiers' drill instructors will receive comprehensive
training in the study procedures prior to beginning the
study to insure their proficiency in administering the
standardized exercise programs. Drill instructors will be
issued detailed pre-prepared training cards specific to each
program and training information will also be available
on a study-related web-site. These training cards will be
used to ensure the proper administration of the training
protocol for a particular company. Study personnel will
be present at training times to ensure compliance with the
assigned exercise program.

Traditional exercise program (TEP)
The TEP was selected from commonly performed exercises
for the rectus abdominus and oblique abdominal mus-
cles. These exercises are traditionally performed in the
military environment and are commonly utilized to assess
physical performance of Soldiers. Soldiers will be
instructed to perform the exercises in a group setting
under the direct supervision of their drill instructor. This
exercise regiment consists of 5 exercises and each will be
performed for 1 minute. The TEP will be performed daily,
for a total dosage time of 5 minutes/day, 5 days per week.
Having Soldiers perform the TEP in group physical train-
ing settings will help ensure compliance with the TEP.

Exercises in the TEP are widely utilized inside (and out-
side) the military for physical training purposes. These


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exercises target the rectus abdominus and oblique abdom-
inal muscles, which are not supported by the accumulated
anatomical, biomechanical, and clinical evidence for pre-
venting LBP [15,24,27,31,38,40]. Furthermore, the exer-
cise prescription emphasizes quick activation, high load,
and high repetitions with full movements of the trunk and
this type of prescription does not match these muscles'
function [38,67]. We believe the TEP will not effectively
prevent LBP because it focuses on trunk musculature not
highlighted in the LBP prevention literature and exercises
muscles in a sub-optimal manner.

Core stabilization exercise program (CSEP)
The CSEP will consist of exercises from the accumulated
evidence shown to selectively activate the transversus
abdominus, multifidi, and erector spinae. Soldiers in this
group will perform crunches in lieu of regular sit-ups. Sol-
diers will be issued photographs of the exercises with writ-
ten instruction in technique. Then, Soldiers will be
instructed to perform the exercises in a group setting
under the direct supervision of the drill instructor. This
exercise regiment consists of 5 exercises and each will be
performed for 1 minute. The CSEP will be performed
daily, for a total dosage time of 5 minutes per day, 5 days
per week. Having Soldiers perform the CSEP in-group
physical training settings will ensure compliance with the
CSEP.

The CSEP was selected from current evidence previously
discussed. [15,24,27,31,38,40] This literature demon-
strates that these exercises increase activation of key core
musculature. The exercise prescription for the CSEP fol-
lows a slow activation, low load principle with minimal
trunk movements, that best matches these muscles' func-
tion, according to noted experts in the area [38,67] These
exercises are also supported by the United States Army
Physical Fitness Program's new doctrine, yet they have not
been clinically tested for preventing LBP. We hypothesize
the CSEP will effectively prevent LBP because it focuses on
core musculature highlighted in the LBP prevention liter-
ature and exercises these muscles in an appropriate man-
ner. Table 1 provides a brief comparison of the two
exercise programs.

Psychosocial education program (PSEP)
We elected not to include a traditional education program
in this trial, as prior studies consistently demonstrate tra-
ditional education does not favorably change LBP
beliefs[44,61,62,68] The education program involves
attending 1 educational session during the first week of
AIT for randomly assigned soldiers. The session will
involve an interactive seminar led by study personnel last-
ing approximately 45 minutes. The seminar will consist of
a visual presentation that presently comprises evidence-
based education for LBP.


Table I: Comparison of traditional (TEP) and core stabilization
exercise (CSEP) programs


Exercise

Principle

Activation
Trunk
movements
Dosage
#1

#2


#3

#4

#5


CSEP

Lower load, less
repetitions
Slower
None to minimal

5 minutes/day
Abdominal drawing-
in maneuver crunch
Left and right
horizontal side
support
Hip flexor squat
('wood-chopper')
Supine shoulder
bridge
Quadruped alternate
arm and leg


TEP

Higher load, more
repetitions
Faster
Full

5 minutes/day
Traditional sit-up

Sit-up with left trunk
rotation

Sit-up with right
trunk rotation
Abdominal crunch

Traditional sit-up


TEP, traditional exercise program; CSEP, core stabilization exercise
program


The seminar will cover topics like the prognosis of LBP,
stressing that anatomical causes of LBP are not likely, and
emphasizing the importance of decreasing fear-avoidance
beliefs and pain catastrophizing in response to LBP. Edu-
cational material about the natural course of low back
pain will be included. After the seminar, Soldiers will be
involved in a question and answer session led by study
personnel. Finally, Soldiers will be issued The Back Book
for their personal use. The Back Book is being used because
we have prior experience with it and it has been demon-
strated to reduce fear-avoidance beliefs [43,44]. Proper
administration of the PSEP will be ensured by having
study personnel lead the educational session for Soldiers
assigned to receive PSEP.

Blinding
It is not possible to mask Soldiers in this study because
they will actively participate in the randomly assigned
training programs. Post-training physical examinations
and real time ultra-sound imaging will be performed by
personnel unaware of program assignment. Soldiers will
be instructed not to discuss their group assignment with
study personnel during post-training examinations unless
there is an urgent reason to do so (e.g. for medical rea-
sons).

Measures
Study related measures are separated into proximal out-
come measures, consisting of self-report and physical
measures (pre and post AlT), and distal outcome meas-
ures, consisting of LBP episode-related measures (2 years
active duty).


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Proximal outcome self-report measures (pre and post training)
Physical and Mental Function
The Medical Outcomes Survey 12-Item Short-Form
Health Survey (SF-12) will be used as a self-report of
health status for physical and mental function. The
derived physical component summary scale (PCS) and
mental component summary (MCS) are believed to be a
valid option to represent the eight domains of physical
and mental components of health [69].

Negative Affect
The State-Trait Anxiety Questionnaire (STAI) will be used
to measure negative affect from anxiety [70]. The Beck
Depression Inventory (BDI) will be used to measure neg-
ative affect from depression [71-73].

Fear of Pain
The Fear of Pain Questionnaire (FPQ-9) will be used to
measure fear about specific situations that normally pro-
duce pain [74-761.

LBP Beliefs
The Back Beliefs Questionnaire (BBQ) will be used to
beliefs about management and outcome associated with
LBP [61,77].

Proximal outcome physical measures (pre and post training)
Randomly selected Soldiers (n = 20) from each company
will undergo physical measures. This decision was made
due to the time and expense associated with performing a
physical examination and real-time ultrasound imaging
on a sample this large.

Physical Impairment
Total lumbar flexion and straight leg raise from the phys-
ical impairment scale described by Waddell et al [78] will
be used in this study. Range of motion measurements of
bilateral hip internal and external rotation will be used.
Additionally, 4 trunk endurance tests will be used for
maintaining extensor, flexor, and bilateral side support
positions.

Real-Time Ultrasound Imaging
All real-time ultrasound measurements of the deep trunk
muscles will be obtained using a Sonosite 180 Plus (Son-
osite Inc. Bothell, WA) with a 5 MHz curvilinear array for
the lateral abdominal muscles and the posterior trunk
muscles [79]. Ultrasound measurements of the lateral
abdominal muscles transversuss abdominus, internal
oblique, and external oblique) during the active straight
leg test maneuver will be obtained following the tech-
niques outlined by Teyhen et al [80] Symmetry measure-
ments of the multifidi muscles will be performed as
outlined by Hides et al [81].


Distal outcome low back pain (LBP) episode-related measures
We will follow Soldiers for 2 years following graduation
from AIT to record the number and the severity of LBP epi-
sodes experienced. Monthly emails containing a link to
the University of Florida hosted POLM website will query
Soldiers on whether they have experienced any LBP in the
last calendar month, and if so, the Soldiers will be
prompted to complete the information described below.

Compliance
Compliance to the Soldiers' randomly assigned exercise
and education programs will be recorded for each month.

Onset of LBP
Soldiers will be queried whether they have experienced
LBP in the last calendar month. If they have, Soldiers will
be cued to answer following validated self-report ques-
tionnaires.

Disability
Self-report of low back-related disability will be assessed
with the Oswestry Disability Questionnaire (ODQ), a
scale originally described by Fairbank et al [82]. The ODQ
that will be used in this study was modified from the orig-
inal version by substituting a section regarding employ-
ment/home-making ability for the section related to sex
life [83,841.

Pain
Patients will rate their pain intensity and unpleasantness
using a numerical rating scale (NRS). The NRS consist of
11 points whose endpoints are designated as '0 no pain
sensation' and '10 the most intense pain sensation
imaginable.'

Fear-Avoidance Beliefs
The Fear-Avoidance Beliefs Questionnaire (FABQ) will be
used to quantify fear-avoidance beliefs in this study [53].

Pain Catastrophizing
The Pain Catastrophizing Scale (PCS) will be used to
quantify pain catastrophizing [85].

Data analysis
Demographic and baseline levels of clinical variables will
be compared between the 4 cluster randomized groups
using analysis of variance (ANOVA) for comparison of
means and chi-square tests for comparison of propor-
tions. Variables found to be significantly different
between the training groups will be considered in the final
analyses, in addition to prespecified covariates (gender,
age, and physical impairment). Six analyses will be per-
formed based on our pre-specified hypotheses. Primary
outcomes will be analyzed with Poisson regression for
occurrence of LBP and Cox regression for time to first epi-


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sode of LBP. Secondary outcomes will be analyzed with
MANOVA and ANOVA models. Based on Bonferroni
adjustment, we will conduct each of the hypothesis tests
two-sided at the 0.008 levels. All statistical analyses will be
performed using the SAS software, version 9 (SAS Institute
Inc, 1996).

Sample size estimation and power analysis
Company size and consent rate are expected to vary, so
the following represent the assumptions used for a sample
size estimation and power analysis. A total of 16 compa-
nies could potentially be randomly assigned to the 4 pro-
grams, with approximately 200 eligible Soldiers per
company, and 75% are expected to provide consent for
study participation. Our sample size estimation was based
on determining the effect of the CSEP and PSEP on pre-
venting the occurrence and severity of LBP episodes.

We expect that 33% Soldiers performing a prevention pro-
gram will experience LBP compared to 51% for those in
the control group [86]. For a group difference of such
magnitude, a two-sided statistical test at 0.008 level
should have more than 99% of power for 4 companies of
soldiers. However, we will enroll up to 16 companies
because only the Soldiers reporting LBP will be included
in certain hypotheses. With 16 companies, we expect
approximately 450 soldiers in the combined program and
675 soldiers in traditional program group to experience
LBP. Data in Table 2 demonstrates the expected power to
detect differences among Soldiers experiencing LBP using
pilot estimates from George et al [44].

For our proximal outcomes, we will randomly sample Sol-
diers from each company. These Soldiers will be assessed
by physical examination and with real-time ultrasound
imaging to measure changes in specific core muscles dur-
ing AlT. Our assumptions for power calculations were that
statistical tests will be conducted at the 0.007 levels and
we conservatively assumed that the differences in specific
core musculature between Soldiers completing CSEP and
those not completing CSEP in this study would be at least
half the amount seen in the pilot estimates from Teyhen
et al [80]. A sample size of 16 companies will provide
more than 90% power as shown in Table 3.


Treatment of Soldiers not completing training protocol
There is approximately a 20% attrition rate for Soldiers
not completing AlT. The reasons for attrition are varied,
but can be broadly defined into medical, physical, per-
sonal, academic, or behavioral categories. Decisions
regarding Soldier attrition are made by Commanding
Officers, independent of the study investigators. There-
fore, we have no direct influence on Soldier attrition rates.
The consequence of attrition for the Soldier is that he or
she joins another company and resumes AlT. The conse-
quence of attrition for the proposed analysis plan is that
the reassigned Soldier will likely be performing a different
training protocol than original assigned. Therefore, such
soldiers represent a potential internal validity threat to
this study.

The following a priori decisions have been made to
account for Soldiers that consented to study participation,
but did not complete AlT. First, any Soldier completing
less than 10-weeks of AlT will have the reason for attrition
recorded, and will not be followed during active duty. Sec-
ond, the reasons and rates of attrition will be compared
between the 4 cluster randomized groups using chi-square
tests for comparison of proportions. This approach will
allow the investigators to protect the internal validity of
the study, by ensuring Soldiers receiving multiple inter-
ventions of unknown duration are not followed during
active deployment. This approach will also allow the
investigators to determine if the attrition rates were con-
sistent across companies throughout the length of the
study.

Treatment of missing data
We will handle missing data values with a 3-step process.
First, the dropout rates will be compared across the pro-
grams to assess systematic differences. Second, demo-
graphic and dependent variables will be examined for
their relationship to dropout. Those variables related to
dropout status will be used to impute missing values for
use in the analyses described below (via Missing Items
Analysis). This multiple imputation approach will be
compared to a last observation carried forward approach,
mixed models approach, or worst-case approach to miss-
ing data. In addition, we will analyze completers only, as
a liberal estimate of treatment efficacy. Finally, compari-


Table 2: Power estimates for low back pain episode specific outcomes


Measure of LBP
severity


Traditional program


Combined program


Power
(16 companies)


Power (I 2 companies)


FABQ (physical activity)
FABQ (work)
ODQ


13.5 (sd = 7.0)
12.3 (sd = 12.3)
15.5 (sd = 17.9)


10.1 (sd = 5.9)
9.7 (sd = 10.2)
11.9 (sd = 10.0)


100%
86%
92%


FABQ, Fear-avoidance beliefs questionnaire; ODQ, Oswestry disability questionnaire


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BMC Musculoskeletal Disorders 2007, 8:92




Table 3: Power estimates for muscle imaging outcomes


http://www.biomedcentral.com/1471-2474/8/92


Power
(16 Companies)


100%
90%
100%


TEP, traditional exercise program; CSEP, core stabilization exercise program


son of the completers vs. imputation analyses will yield an
additional estimate of the effect of dropouts on hypothe-
sis tests.

Discussion
We have presented the design and protocol for the POLM
trial. We will train Soldiers with specific exercise and edu-
cation programs and measure the occurrence and severity
of LBP episodes over a 2-year period. Completion of this
trial will provide important information on how to effec-
tively train U.S. Soldiers for the prevention of LBP. Results
of the POLM trial will be disseminated as soon as they are
available.

Abbreviations
LBP, low back pain; AIT, advanced individual training;
CSEP, core stabilization exercise program; PSEP, psycho-
social education program; MOS, military occupational
specialty; POLM, Prevention of low back pain in the mili-
tary trial; FAM, Fear-avoidance model; TEP, Traditional
exercise program; STAI, State-trait anxiety questionnaire;
FPQ, Fear of pain questionnaire; BBQ, Back beliefs ques-
tionnaire; SF-12, Medical outcomes survey 12-item short-
form health survey; PCS, Physical component summary
scale; MCS, Mental component summary scale; ODQ,
Oswestry disability questionnaire; NRS, numerical rating
scale; FABQ, Fear-avoidance beliefs questionnaire; PCS,
Pain catastrophizing scale

Competing interests
The authors) declare that they have no competing inter-
ests.

Authors' contributions
All authors read, edited, and approved the final version of
the manuscript. SZG, JDC, DST, SSU, and MER were
responsible for the initial conception of the research ques-
tion, securing funding, supervising the protocol, and
manuscript preparation. ACW and JLD were responsible
for implementing study protocol and critically reviewing
earlier versions of this manuscript.

Acknowledgements
The POLM trial is supported by the peer-review medical research program
of the Department of Defense (PR054098). We would like to thank Chris-


topher Barnes and Yang Li for creation and management of POLM website
and database. We would also like to thank Donna Cunningham for her
administrative assistance.

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