Desai et al.

BMC Musculoskeletal Disorders (2019) 20:249

https://doi.org/10.1186/s12891-019-2625-x

STUDY PROTOCOL Open Access

The Back Pain and Movement (B-PAM)

registry; a study protocol
Mehul J. Desai1,2, Holly Jonely2, Meagan Blackburn3, Sangeeth Wanasinghage3* , Sidrah Sheikh1 and Rod S. Taylor4

Abstract
Background: Low back pain (LBP) is a ubiquitous, heterogeneous disorder that affects most people at some point
in their lives. The efficient management of LBP remains elusive, with direct and indirect costs attributed to LBP
surpassing many other common conditions. An emphasis on a structural basis of LBP often fails to recognize
movement, specifically patterns of movement that may provide biomechanical signatures of painful conditions. The
primary objective of this registry is to understand the differences in movement patterns among those with LBP and
those without pain in a U.S. population sample.
Methods: This ongoing, non-randomized, prospective post-market registry will consist of two groups: patients with
LBP, and age and sex-matched controls without LBP. We will seek to recruit 132 subjects in each group. Data
collection will take place in two phases: (1) baseline assessment of LBP patients and matched controls; (2)
assessment of LBP patients at 6 and 12-months follow up. The primary outcome measure will be differences in
movement patterns between those with LBP and those without LBP. Secondary outcomes will include differences
in patient reported outcomes including pain, disability and quality of life.
Discussion: The findings will help determine if there are meaningful differences in movement patterns between
those with and those without LBP. Further, an initial understanding of movement signatures specific to certain
subtypes of patients with LBP may be achieved.
Trial registration: The study was registered on the clinicaltrials.gov portal: NCT03001037. Trial retrospectively
registered 12/22/2016.
Keywords: Low Back pain, Registry, Technology, Movement, Inertial measurement unit

Background skill and expertise of the examiner. Moreover, assess-

Low back pain (LBP) represents a complex constellation ments of these key factors frequently rely on the “eyes”
of conditions that commonly afflicts the adult popula- of the clinician and the subjective feedback of the
tion. As the main contributor to years lived with disabil- patient.
ity [1], it is an enormous public health issue, with A systematic review and meta-analysis of studies com-
associated expenditures being three times greater than paring lumbo-pelvic kinematics in people with and with-
diabetes, cancer and heart disease [2]. Despite these out back pain demonstrated significant limitations in the
costs, the treatment and prognosis for persistent LBP re- included studies, specifically a lack of detail or
main quite poor. Unfortunately, symptomatic misman- standardization between studies on the criteria used to
agement of LBP likely represents an underlying lack of define participants as those with LBP or without LBP
understanding of the multifactorial contributions to the [3]. Furthermore, the reliability of the most common
condition. Importantly, dynamic real-time understanding means of measuring lumbar sagittal motion (plurimeter
of movement patterns and biomechanics have historic- V double inclinometer, the carpenter double inclinom-
ally been rudimentary and are often dependent upon the eter and the computerized single sensor inclinometer)
was found to be greatly varied, falling below clinically
desirable levels with errors primarily attributed to the
* Correspondence: [email protected]
3
dorsaVi Ltd, 86 Denmark Street, Kew, Victoria 3101, Australia examiner [4]. Using 3D lab-based motion analysis,
Full list of author information is available at the end of the article

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Desai et al. BMC Musculoskeletal Disorders (2019) 20:249 Page 2 of 9

Hemming et al. [5] evaluated spinal kinematics between adapt to carry out the same motion as those who are
healthy individuals and subjects with chronic low-back asymptomatic.
pain. They observed significant differences in Other studies of posture and back movements com-
lower-thoracic and upper-lumbar movement during bined inertial sensors with electromyography (EMG) sen-
functional tasks in a UK-based population. However, sors. In a preliminary study of the mDurance device,
they specified a lack of analysis of muscle activity as a Banos et al. [10] conducted trunk endurance assessments
limitation to better understand underlying pain mecha- on subjects currently undergoing physical therapy. The
nisms. Moreover, they noted that use of continuous pos- device was effectively able to manage movement data re-
tural measurement devices may improve understanding corded during the tests. In a cross-sectional study by Laird
around movement-related behavior, and behavioral et al. [11] used the combined motion and surface electro-
change [5]. myography (sEMG) capabilities of ViMove and observed
Recent technological advances offer new opportunities diminished range of motion in the trunk, lumbar, and pel-
for accurate, convenient measurement of movement and vis along with slowed overall movement in those with low
posture as correlated to pain, thus theoretically allowing back pain. They also noted significant differences of
a more in-depth understanding of the foundations of flexion-relaxation between LBP and healthy controls as
chronic LBP. Laird et al. [6] utilized wireless, wearable, assessed through sEMG. However, the study was limited
sensor technology (ViMove; dorsaVi Ltd., AUS) to evalu- to evaluation of flexion and seated postures, and only ex-
ate lumbo-pelvic kinematic patterns during sagittal amined univariate relationships.
flexion movements. They identified four subgroups To better understand and characterize movement pat-
which distinctly differ in range and speed of motion, terns both in populations with and without LBP in a
muscle relaxation, and lumbo-pelvic contribution to broader set of movements, dorsaVi established the Back
movement. These findings demonstrated the feasibility Pain and Movement (B-PAM) Registry. The purpose
of subgrouping without pre-classification based on ob- of B-PAM is to provide baseline, follow-up, and nor-
servation or subject history and highlighted the hetero- mative data pertaining to single-plane and dynamic
geneity of lumbo-pelvic kinematics within an LBP movements of normal controls as well as those with
sample. They also support the notion of improving treat- LBP, as assessed by ViMove, in a U.S. sample popula-
ment efficacy by tailoring to kinematic deficits as op- tion. ViMove is capable of continuously measuring
posed to subjective pain experiences or observations. 3-dimensional lumbosacral movements and sEMG for
It is of note that sagittal flexion was the only evaluated up to 24 h. This system has been validated against
movement, with no inclusion of other single-plane or gold standards for motion analysis including Optotrak
multi-plane movements. As such, functional and Vicon motion capture systems where it demon-
movement-related classifications described by Hemming strated clinically acceptable agreement with these mo-
et al. [5] were not incorporated. Similarly, O’Sullivan [7] tion laboratory-based systems [12]. The movement
described specific classifications which manifest only consistency of ViMove between tests on the same and
during functional tasks. However, the study was limited different days has also been evaluated for flexion, ex-
to an Australian population, and as discussed by the au- tension, and lateral flexion [13]. Intraclass correlations
thors, results have not been verified in an independent of r = .88 (range .80 to .98) and r = .85 (range .69 to
sample. .97) were observed respectively indicating good to ex-
Matheve et al. [8] assessed the effectiveness of cellent agreement. ViMove has received FDA 510(k)
sensor-based postural feedback in modifying clearance and is commercially available.
lumbo-pelvic motor control in Belgian patients with By extending on previous research which only focused
chronic LBP, and healthy controls. The intervention on certain movements, and by additionally evaluating
comprised of two movement control tasks conducted in sEMG, B-PAM seeks to provide an extensive repository
a single exercise session (lifting task & waiter’s bow). of data for use in defining assessment and treatment al-
The authors concluded that postural feedback was ef- gorithms while evaluating performance of specific move-
fective in improving lumbo-pelvic control. Tsang et al. ments. The B-PAM data is intended to benefit and
[9] evaluated the difference in lumbo-pelvic movement support interests of patients, practices, hospitals, clini-
patterns between healthy and low back pain subjects cians, regulatory bodies, payers and industry by stream-
using a 3-dimensional inertial sensor system (3D Myo- lining the clinical surveillance process and facilitating
Motion). Seventeen males with low back pain and eight- leading edge performance assessment while also gather-
een males without were instructed to bend forward at ing baseline data without intrusion into clinical
five selected speeds while wearing the sensors. The study pathways.
evidenced the system’s ability to track movement pat- The registry seeks to address the following questions
terns and highlighted that subjects with low back pain in a U.S. population sample:
Desai et al. BMC Musculoskeletal Disorders (2019) 20:249 Page 3 of 9

1. Are there differences in range of movement and  Exclusion criteria required by local law
kinematics (e.g. speed and pelvic/lumbar  Movement assessment is contraindicated for any
contribution of movement) between patients with reason.
LBP and subjects without LBP?  Currently enrolled in or plans to enroll in any
2. Are there differences in secondary outcomes (leg/ concurrent drug and/or device study that may
back pain, depression, health-related quality of life) confound results
between those with LBP and without LBP?  Body mass index ≥35 kg/m2
3. Are there identifiable lumbo-kinematic patterns and
muscle-activity associated with LBP patients during Controls will be recruited using study advertisement
single-plane and dynamic movement? flyers posted on campus at the George Washington Uni-
4. Are there associations between the demographic versity, local gymnasiums, recreational centers, via word
and clinical characteristics (e.g. age, gender, level of of mouth, and email list servers associated with educa-
back pain) and kinematic outcomes in LBP tional programs within The George Washington Univer-
patients? sity School of Medicine and Health Sciences. Subjects
will be screened by phone for the presence or history of
Methods/design LBP (no current LBP and no history of LBP lasting lon-
This is an ongoing, non-randomized, prospective ger than 3 months in the past 12 months) as well as
post-market registry consisting of two groups: patients other exclusion criteria listed above. Controls will be age
with LBP, and age and sex-matched controls without and sex-matched with LBP patients on a one-to-one
LBP. We will recruit a total of 132 subjects in each basis.
group. B-PAM has a flexible design to allow new dorsaVi
products to be added to the registry following their mar- Minimization of bias
ket release. Data collection will take place in two phases: The following procedures have been incorporated to
(1) baseline assessment of LBP patients and matched minimize potential bias:
controls; (2) assessment of LBP patients at 6 and
12-months follow up.  Sites will screen and consecutively enroll all subjects
Reporting and data analysis of the B-PAM registry who undergo assessment.
will be undertaken in accord with The Strengthening  The Principal Investigator will be blinded to results
the Reporting of Observational Studies in Epidemi- of assessment.
ology (STROBE) guidelines for reporting observational  Sites must meet pre-defined criteria to be selected
studies [14]. to participate.
 Standard operating procedures for data collection
Site selection will be employed across study sites with a single
Sites participating in B-PAM will initially be two clinical common database for all sites.
centers in Washington DC, USA (International Spine
Pain & Performance Center and Synergy Manual Phys- Sample size
ical Therapy). Detection of a ‘moderate’ effect size (i.e. Cohen’s effect
size of ≥0.40 in range of movement and other outcomes)
Subject selection between LBP and controls requires 132 individuals per
Subjects with LBP will be included if they fulfil the fol- group at 90% power and alpha of 5% (estimated using
lowing criteria: STATA’s sampsi command) [15].
Based on this sample size and using data in individuals
 Subject or legally authorized representative provides with no back pain reported by Laird (Monash University,
written authorization and/or consent per institution Research Project Report No: cf11/0748–2,011,000,372),
and geographical requirements Table 1 shows the predicted minimum mean difference
 Subject with a predominant complaint of LBP of any that could be detected between back pain and control
duration, with a minimum daily pain average visual groups. The magnitude of these predicted between-group
analogue score (VAS) ≥ 30/100 differences in range of movement appear to be fairly con-
 Subject is intended to be assessed with the eligible sistent with those reported in the meta-analysis conducted
product by Laird et al., evaluating previously published studies
comparing LBP and control populations [3].
Exclusions to enrollment are: We have also estimated the impact sample size of 132
back pain individuals in terms of achieving our second
 Unable to be available for study follow-ups research objective of assessing the subject demographic
Desai et al. BMC Musculoskeletal Disorders (2019) 20:249 Page 4 of 9

Table 1 Range of motion and predicted minimum mean  Insurance certificates (as required by geography).
differences between back pain and control groups  Applicable Regulatory Approval (as required by
ROM Non-back pain group Observed Predicted minimum geography).
outcome Mean (SD) mean difference  Documented training; signed and dated.
between control
and back pain group
Lordosis
Subjects can exit from B-PAM if: they choose to with-
draw, reach end of their follow-up period, the investiga-
30–39 -30 (6.9) ± 2.76
years tor deems withdrawal is necessary (e.g. medically
justified, failure of subject to maintain adequate registry
40–49 −32 (10.1) ± 4.04
years compliance, or if the subject is no longer available for
50–65 − 36 (12.2) ± 4.88
follow-up.
years
Standing flexion
Measurements
30–39 46 (11) ± 4.4
years General data collection procedures and the scope and
40–49 48 (6) ± 2.4
timing of demographic data outcome collection are sum-
years marized in Tables 2 and 3 respectively.
50–65 46 (9) ± 3.6 The dorsaVi ViMove system consists of two wireless
years tri-axial inertial measurement sensors containing accel-
Standing extension erometers, gyroscopes, and magnetometers. These allow
30–39 −26 (10) ± 4.0
evaluation of movement in all three anatomical
years planes. Additionally, two wireless, bipolar, ViMove
40–49 −18 (11) ± 4.4 surface electromyography (sEMG) sensors will be
years placed on the subject’s low back via a disposable
50–65 −17 (14) ± 5.6 adhesive safe for human-use at standardized locations
years based on anatomy and subject height. Once these
sensors are placed (at approximately the
and clinical characteristics associated with range of L3-vertebrae), the subject will be asked to move
movement. Based on the rule of thumb of 10 observa- through a sequence of assessments (see Table 4).
tions needed per covariate (or predictor) [16], 32 indi- Motion sensor data will evaluate range of motion, ac-
viduals with back pain would allow for a multivariable celeration, and velocity of movement, lumbo-pelvic con-
regression including up to 13 covariates. 132 subjects tribution to movement, and onset of lumbar/pelvic
would also allow detection of an increase in the f2 of movement.
multivariable model with 9 covariates from 50 to 55%
with the inclusion in the model of one additional covari- – Contribution of pelvis vs. lumbar movement is
ate at 90% power and 5% alpha (using STATA’s powerreg calculated as the peak lumbar angle divided by
command) [17]. trunk peak angle at end-range trunk flexion. This
is evaluated in the movement ‘Flexion’ as defined
Ethical approval in Table 4.
Prior to enrolling any subjects into B-PAM, sites must
fulfil all local law and regulatory requirements. The term
Ethics Board will be used to define the Institutional Re- Table 2 Summary of data collection
view Board (IRB), Medical Ethics Committee (MEC), Re- Enrollment Baseline/ Follow-Up Exit
Assessment
search Ethics Board (REB) or Human Research Ethics
CF or DRF Signed X X
Committee (HREC). Participation readiness includes but and Dated
is not limited to:
Subject Demographics X X X X

 Ethics Board approval or a written statement by the Outcome Measures X X X X

Ethics Board Chairperson stating that approval is Medical History X
not required. Assessment Details X X X
 Approval of the Informed Consent (CF) or Data Patient Status X X X X
Release Form (DRF) by the Ethics Board and/or Events X X X X
sponsor (if required).
Protocol Deviations X X X X
 A legally executed Agreement.
Desai et al. BMC Musculoskeletal Disorders (2019) 20:249 Page 5 of 9

Table 3 Summary of collected demographic and outcome data sEMG data is automatically processed by ViMove as
Demographic measures LBP Controls follows:
Patients
Age X X – Data is sampled at a frequency of 300 Hz
Gender X X – A Band-Pass Filter is applied at 20 − 300 Hz
Pain episode duration (weeks) X X  High-Pass Filter set to 20 Hz to reduce baseline
drift and ECG components
Body Mass Index (BMI) X X
 Low-Pass Filter set to 300 Hz to create an
Employment (working vs not working) X X
envelope of the signal which is then anti-aliased
Marital Status X X and down-sampled.
Co-morbidities (categories) X X – This signal is then used to calculate a moving root-
Co-interventions - current medications X X mean-square average.
(categories)
Co-interventions - (hospital admissions, X X LBP patients and non-LBP controls will be assessed at
doctor or other clinician visits, enrolment (baseline). LBP patients will then then be
imaging, other diagnostic tests,
followed up at 6 and 12 months (see Fig. 1).
Patient outcomes
LBP diagnosis (ICD-10) - clinician X
Statistical analysis
LBP – movement pattern X Baseline characteristics of LBP and controls will be re-
classification (clinician)
ported descriptively as means (and standard deviations)
LBP – Movement Classifier X
or medians (and inter-quartile ranges) for continuous
QVAS - back X X variables, or frequencies (and percentages) for binary
QVAS - leg X X variables. Groups will be compared using the independ-
Oswestry Disability Index (ODI) X ent 2-group t-test, Mann-Whitney U test, or Chi2–test
START-Keele X respectively.
Fear Avoidance Behavior Questionnaire (FABQ) X
EQ-5D X X Comparison of range of movement and secondary
outcomes between LBP subjects and non-LBP controls
Depression Anxiety Stress Survey 21 (DASS-21) X X
Continuous primary and secondary outcomes will be
Patient perception of movement contribution to X
pain - single item
compared between LBP and control groups using linear
regression methods, and categorical outcomes will be
Movement outcomes
compared using logistic regression. Models will be ad-
ViMove standard assessment (includes range of X X justed for baseline outcome scores (ANCOVA) plus
motion, speed, and timing of movement as
described in “Measurements”) matching variables and other characteristics found to be
30 s sit-to-stand test X X
significantly different between groups at baseline.
Between-group comparisons will be undertaken at base-
40 m walk test X X
line and each follow up. Within group differences in out-
comes between baseline and follow up will also be
examined. Residual plots will be used to check goodness
– Onset of lumbar/pelvic movement is similarly of fit of regression models and, where necessary, power
evaluated in the ‘Flexion’ task. Start of the transformation of outcomes undertaken to improve
flexion was defined as the point at which the model fit.
velocity of movement exceeds 7°/s. This
definition is automatically detected by the Association between demographic and clinical
ViMove software. characteristics and range of movement outcomes in LBP
subjects
Motion data is automatically processed by ViMove as Pearson correlation coefficients will be used to assess
follows: the univariable association between range of movement
and various back pain subject characteristics. Multivari-
– Accelerometer and gyroscope readings are low-pass able associations will also be assessed using multivariable
filtered with a zero-phase, second-order Butterworth Pearson correlation coefficients and multivariate linear
filter, and cut-off frequency of 5 Hz [18]. Data is regression analysis. In determining multivariable models,
sampled at 20 Hz. collinearity between potential variables will first be
Desai et al. BMC Musculoskeletal Disorders (2019) 20:249 Page 6 of 9

Table 4 ViMove (dorsaVi) Assessment

Posture / Movement performed by subject: Instructions to the Subject
Standing – ‘normal’ posture (calibration) ● Warm up – walk at comfortable pace for 20 s.
● Stop and reach towards the ceiling as high as you can.
● Stand with feet hip distance apart.
● Look straight ahead.
● Now we are going to measure your posture
● Stand still whilst I count to 5.
Flexion (subject chooses speed, using support for We want to see how you bend forward.
balance if required) ● When I say go, bend forward as far as possible, hold for 3 s,
and then return to the starting position.
● Repeat this × 3
Extension We want to see how you bend backward.
● Cross your arms over your chest.
● When I say go, bend back as far as possible and then return
to the starting position.
● Repeat this × 3
Lateral flexion - right We want to see how you bend sideways.
● Place your arms by your side.
● When I say go, slide your right arm down your right leg as far
as possible and then return to starting position.
● Repeat this × 3
Lateral flexion - left We want to see how you bend sideways.
● When I say go, slide your left arm down your left leg as far as
possible and then return to starting position.
● Repeat this × 3
Pelvic tilt in standing We want to see how you move your pelvis and see if you can
move it without moving the rest of your body.
● This is how you tip your pelvis forward (demo) and this is how
you tip your pelvis back. One forward and one back counts as
one total movement.
Have a practice (max 10 s) and I will start recording your movement.
● I want you to do this at least 3 times.
Usual sitting posture (as demonstrated by subject) Take a seat in your chair. Show us how you usually sit.
Poor sitting posture (as demonstrated by subject) Now show us how you sit when you are sitting poorly.
Good sitting posture (as demonstrated by subject) Now show us how you sit when you are sitting in a good position.
Pelvic tilt in sitting – through full range We want to see how you move your pelvis in the chair and see if you
can move it without moving the rest of your body.
● Sit to the front of the chair.
● Roll forward as far as possible and then roll back onto your Tailbone
as far as possible.
This is how you tip your pelvis forward (demo) and this is how you
tip your pelvis back.
Have a practice (max 10 s) and I will start recording your movement.
● I want you to do this at least 3 times.
40 m (4x10m) Fast Paced Walk Test “For this test, do the best you can by going as fast as you can, without
running, but don’t push yourself to a point of overexertion or beyond
what you think is safe for you.
1. Start with both feet on the start line.
2. On start, walk as quickly but as safely as possible, without running.
3. Walk up to the end cone, turn around and walk back to the starting
cone behind you, turn again and back to the end cone, then turn once
more and return to the start cone again so that you walk the 10 m
walkway 4 times in total.
4. Get ready and START”.
30 s sit-to-stand test “For this test, do the best you can by going as fast as you can but don’t
push yourself to a point of overexertion or beyond what you think is safe for you.
1. Place your hands on the opposite shoulder so that your arms are crossed at
the wrists and held close across your chest. Keep your arms in this position for the test.
2. Keep your feet flat on the floor and at shoulder width apart.
3. On the signal to begin, stand up to a full stand position and then sit back down
again so as your bottom fully touches the seat.
4. Keep going for 30 s and until I say stop.
5. Get ready and START”.
Desai et al. BMC Musculoskeletal Disorders (2019) 20:249 Page 7 of 9

Fig. 1 Schematic of study design

assessed and variables where high collinearity will be in a locked file cabinet. Access will be controlled as dele-
excluded. gated by dorsaVi to either a contract research
The focus on all data analyses will be on those registry organization (CRO) or to the principal investigator’s
participants with complete data. However, we will report clinical site. This will allow for independent manage-
rates and reasons for missing data and, where appropri- ment of the data, which will be blinded to the investiga-
ate, consider imputation of missing cases using appro- tors. The database will be backed up regularly.
priate statistical methods. The role of the CRO or Principal Investigator’s site
All inferential analysis results will be reported as mean would include data checking, data cleaning and data
differences and 95% confidence intervals. We will report scoring. Ultimately, a scored/cleaned data set would
P-values to three decimal places with P-values less than then come to the study statistician to run the actual
0.001 reported as p < 0.001. All statistical tests will be data analyses, further this data set would be provided
performed using two-sided tests at the 0.05 level of sig- to dorsaVi. dorsaVi may delegate an entity (CRO) to
nificance. No formal adjustment of the level of signifi- review site reported data to monitor quality. Data dis-
cance for testing will occur, but P-values will be crepancies will be highlighted as required and for-
interpreted accordingly, considering the multiple testing warded to the site for resolution. Site personnel are
outcomes. An analysis will be undertaken at the end of responsible for the timely submission or data and the
the phase I, upon completion of enrolment of the age resolution of discrepancies per their standard of care
and sex-matched cohorts, prior to proceeding with en- practices.
rolment of phase II of the registry.
All analyses will be undertaken using STATA version
14 [17]. Discussion
The Back Pain and Movement (B-PAM) registry pro-
Data and quality management vides the infrastructure to utilize the dorsaVi system to
Data will be collected using an electronic data manage- objectively measure movement and muscle activity in
ment system and hard copy forms. Data reporting will order to better understand movement patterns in LBP
be completed and submitted by the investigator or au- and non-LBP control populations. Furthermore, move-
thorized staff. All data will be stored in a secure, ment signatures among cohorts with similar diagnoses
password-protected database with a hard-copy backup may be identified.
Desai et al. BMC Musculoskeletal Disorders (2019) 20:249 Page 8 of 9

Back pain registries Funding

There are several ongoing registries that collect similar dorsaVi will be partially funding this study and will supply the ViMove
technology being used. An employee of dorsaVi (MB) was involved in the
data. The Back-Pain Outcomes Using Longitudinal Data development of the study design.
(BOLD) project specifically focused on those older than
65 with a new episode of LBP. This registry collects data Availability of data and materials
Data sharing is not applicable to this article as no datasets have yet been
including diagnostic tests, current treatments, pain, generated or analyzed during the current study.
health-related quality of life and functional disability.
Spine IQ is a registry specifically focused on perform- Author’s contributions
MJD, HJ, MB and RST developed the original concept of the study and
ance measures. Designed to describe the natural history developed the design of B-PAM Registry study. MJD, HJ, MB, SW, and RST
of disease, determine the clinical effectiveness of health provided draft revision. SW and SS contributed to the major revisions. RST
care services and to measure/monitor safety and quality, contributed to the revision of the statistical analysis methodology. All authors
have read and approved the final manuscript of the article.
it is focused on assisting U.S. clinicians with the transi-
tion to value-based care as mandated by U.S. legislation. Ethics approval and consent to participate
Neither registry seems to focus on a deeper understand- Ethics approval was obtained from the George Washington University’s
Office of Human Research (approval number: 051626, 26 September 2016).
ing of movement and its contributions to LBP. Further- All participants provided written informed consent.
more, understanding patterns of movement as they
relate to specific diagnoses are not emphasized. Consent for publication
Not applicable.

Competing interests
Strengths and limitations MJD has previously been a paid consultant to dorsaVi.
Registries have the advantage that they enable easier pa- RST has previously been a paid consultant to dorsaVi.
MB was an employee of dorsaVi at the time of manuscript drafting.
tient enrolment than intervention trials such that large SW is an employee of dorsaVi.
sample sizes are feasible. This increases the external val-
idity, generalizability, and real-world applicability of data Publisher’s Note
collected in registries. The non-observational nature of Springer Nature remains neutral with regard to jurisdictional claims in
registries means that they are subject to confounding, published maps and institutional affiliations.
selection bias, and poor data quality control. We have Author details
sought to minimize these limitations in B-PAM by use 1
International Spine, Pain & Performance Center, 2141 K Street NW, Suite 600,
of age and sex matching of LBP controls, and through Washington, DC 20037, USA. 2The George Washington University, School of
Medicine and Health Sciences, 2300 I St NW, Washington, DC 20052, USA.
rigorous application of measures to ensure data quality. 3
dorsaVi Ltd, 86 Denmark Street, Kew, Victoria 3101, Australia. 4University of
Exeter Medical School, St Luke’s Campus, Heavitree Road, Exeter EX1 2LU, UK.

Future plans Received: 1 January 2019 Accepted: 14 May 2019

We plan to extend the recruitment to additional US sites
at a later date based on the following criteria: References
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