Risk Stratification in Primary Care Combined With Stratified-specific Physical Therapy Care for Low Back Pain

The University of Vermont Health Network is a five hospital network that serves primarily a
rural population of approximately 1 million people in Vermont and upstate New York. The
primary aim of this prospective, longitudinal, pragmatic, non-randomized clustered,
non-blinded, controlled trial is to examine whether PT treatment stratified to match the
patient's risk factors based on the STarT Back Tool is more effective than the current
treatment in primary care for non-specific low back pain (LBP) in improving short- (6 months)
and long-term (12-month) patient outcomes (disability).

To do the risk stratification, investigators will use the STarT Back Tool which is designed
for primary care settings and is validated for non-specific LBP (acute flare-ups or chronic
pain). The tool is designed to identify the prognostic risk (low, medium, high) for
progression to chronic LBP. In addition, the tool assists clinicians in decision making to
ensure that low risk patients are not over treated or medicalized, that 'at risk' patients
get access to the right provider early on and that enhanced care is given for complex cases.
Thus, the tool assists in matching the 'right patient to the right treatment' at the 'right
time' which is critical given the high prevalence and cost of LBP.

Patients with a primary diagnosis of LBP (acute flare-up or chronic) who are seen in any of
the six Family Medicine sites will complete the STarT Back Tool and the Modified Low Back
Pain Disability Questionnaire (mODI). With the non-randomized, cluster design, three of the
Family Medicine sites are identified as "Participating Sites" and three are identified as
"Comparator Sites." Patients with low back pain from "Participating Sites" who are stratified
as medium- or high-risk patients will be referred to physical therapy (PT) for a matched
(i.e., stratified-specific treatment). Those patients who are identified as low-risk will be
retained in Family Medicine for management using advice, reassurance, patient education,
NSAIDs (no imaging or specialist referral is encouraged). Patients with low back pain from
"Comparator Sites" will be managed according to current care practices in Family Medicine.
Using the mODI, the investigators will compare the two study arms at short- (6 months) and
long-term points (12 months).

Inclusion Criteria:

1. diagnosis of acute, chronic or non-specific LBP,

2. between 21 - 60 years of age,

3. able to stand and walk without assistance,

4. able to understand and read English,

5. able to understand and sign a consent form.

Exclusion Criteria:

1. active serious spinal complications such as tumor or infection,

2. active treatment for metastatic or bone cancer of the spine,

3. pregnancy or less than 6 months post-partum or less than 6 months post weaning.