dorsaVi Back Pain and Movement Registry

The first phase of the study will use a non-randomized two-group prospective longitudinal
study design (Group A subjects with LBP, Group B subjects without LBP). The second phase of
the study will use a single-group prospective longitudinal study design (Group A, subjects
with low back pain). A timeline and step-by-step detail of the study procedures for these
phases are also described in Appendix B.

Group A which will include subjects with LBP, members of the research team will screen and
attempt to consecutively enroll all patients who undergo assessment for low back pain at two
clinical locations (International Spine Pain & Performance Center, and Synergy Manual
Physical Therapy). The enrollment and baseline visit can occur at the same time. During
enrollment each subject will privately be briefed on the purpose and involvement in the study
and be allowed to ask questions and opt out if not interested. Informed consent will be
reviewed and signed and each subject will be given a copy of the consent form (15 minutes).
Since collection of "baseline data" (outcome measures and ViMove Assessment) is already
considered standard clinical practice for subjects with low back pain at these clinical
settings, providing informed consent would allow the researchers to access this information
for purposes of the registry. A summary of the information collected at baseline will
include: patient demographics/medical history (age, gender, pain episode duration, BMI,
employment, marital status, comorbidities, co-interventions, ICD-10 LBP diagnosis), outcome
measures (LBP movement pattern classification, LBP Classifier Questionnaire, QVAS for back
and leg, Oswestry Disability index, START-Keele, Fear Avoidance Behavior Questionnaire,
EuroQol-5D, DASS-21, patient perception of movement contribution to pain) (20 minutes), and
an assessment (ViMove standard assessment, 30 sec chair test, 40m walk test) (25 minutes).
See Appendix C.

Group B which will include subjects without LBP, members of the research team will recruit
volunteers within the DC metro area using flyers posted on campus at the George Washington
University, local DC metro gymnasiums and recreational centers, word of mouth and email list
serves associated with educational programs within The George Washington University School of
Medicine and Health Sciences. Subjects will be screened by phone for the presence or history
of low back pain as well as other exclusion criteria. If the subject agrees to move forward
with participation they will be asked to come to The George Washington University Program in
Physical Therapy located at 2000 Pennsylvania Ave Suite 2000, NW Washington DC 20006, or
International Spine Pain & Performance Center or Synergy Manual Physical Therapy. Enrollment
and baseline visits can occur at the same time. During enrollment each subject will privately
be briefed on the purpose and involvement in the study and be allowed to ask questions and
opt out if not interested. Informed consent will be reviewed and signed and each subject will
be given a copy of the consent form (15 minutes). Baseline data will then be collected which
will include: subject demographics/medical history (age, gender, BMI, employment, marital
status, comorbidities, co-interventions) and QVAS for back and leg, EQ-5D, DASS-21 (10
minutes) and ViMove standard assessment, 30 sec chair test, and 40m walk test (25 minutes).
See Appendix C.

ViMove Testing (Groups A & B): The ViMove system (dorsaVi, Australia) which will be used to
assess movement patterns and lumbar muscle activity in both groups during the ViMove standard
assessment, 30 sec chair test, 40m walk test, is an inertial measurement system comprised of
two wireless motion sensors containing a triaxial accelerometer, a triaxial gyroscope and a
magnetometer, two wireless surface electromyography (EMG) sensors, and a small wireless
recording device (RFD) that can be worn by the subject. The manufacturer reports average
differences of < 1 degree for single plane, through range movements when comparing matched
measurements from the ViMove and a Fastrak opto-electronic device (Charry, Umer et al. 2011).
The ViMove motion sensors collect data at approximately 20 Hz.

When ViMove testing is performed for both groups, 4 sensors will be adhered to the subject's
skin using customised biocompatible adhesives. The placement of the sensors is determined
through the use of templates which have been validated as part of the FDA 510K application.
During testing, the sensors communicate data wirelessly to the RFD which is connected to a
computer running dorsaVi (ViMove software). Customised algorithms convert data generated by
the software to meaningful biomechanical information, including measures such as range of
movement, peak angles, speed of movement and muscle activation.

Subjects in Group A will follow-up with their healthcare provider based on standard clinical
care practices. Enrolled subjects in Group A will undergo follow up at 3 months, 6 months and
12 months (45 minutes each session); these follow up visits may or may not coincide with a
regular clinical office visit with their healthcare provider. Subjects in Group B will follow
up at 3 months only (35 minutes).

Follow up will include completing outcome measures and an assessment as collected at baseline
as well as collection of patient status, events, and protocol deviations.

Subjects may exit from the research project under the following circumstances:

- Subject chooses to withdraw (e.g. consent withdrawal)

- At the end of their follow-up period

- Investigator deems withdrawal is necessary (e.g. medically justified, failure of patient
to maintain adequate registry compliance)

- Subject death

- Subject is no longer available for follow-up

Inclusion Criteria:

Group A:

- Subject provides written authorization and/or consent per institution and geographical
requirements

- Subjects in Group A with a predominant complaint of Low back pain, with a minimum
daily average VAS ≥ 30/100

- Subjects in Group A are intended to be assessed with ViMove based on standard of care
- Subject is willing to participate in follow ups at 3, 6, 12 months post initial
assessment

Group B:

- Subject is without current low back pain

- Subject does not have a history of low back pain lasting longer than 3 months in the
past 12 months

- Subject is willing to follow up 3 months post initial assessment

Exclusion Criteria:

- Subject who is, or is expected to be inaccessible for follow-up

- Subject with exclusion criteria required by local law

- Subject in whom movement assessment is contraindicated.

- Subject is currently enrolled in or plans to enroll in any concurrent drug and/or
device study that may confound results

- Body mass index ≥ 35 - In Group B only, subjects who had a history of low back pain in
the past 12 months which lasted > 3 months