Clinical trial NCT03065894: Risk Stratification in Primary Care Combined With Stratified-specific Physical Therapy Care for Low Back Pain
Official title: Does Risk Stratification in Primary Care Combined With Stratified-specific Physical Therapy Care Improve Clinical Outcomes for Patients With Nonspecific Low Back Pain Compared to Those Who Receive Only Current Care?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Low Back Pain
Keywords: stratified care
psychologically informed practice
matched care
Lead sponsor: University of Vermont Medical Center
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, longitudinal, pragmatic, non-randomized clustered, non-blinded, controlled trial
Primary purpose: TREATMENT

Brief summary: This study aims to examine patient outcomes following risk stratification for low back pain in Family Medicine combined with either matched physical therapy (PT - i.e., stratified-specific PT) treatments or current treatment in primary care across The University of Vermont Health Network.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Modified Low Back Pain Disability Questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
affiliation: The University of Vermont Medical Center
name: Sharon M Henry, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: