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

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?

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.

Study Overview

• Status: Terminated
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Matched Physical Therapy Intervention; Other: Current Care in Family Medicine

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).

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stratified Care; In three "Participating Sites" from Family Medicine sites, the Keele STarT Back Screening Tool will be administered to patients with acute and chronic low back pain and based on patients' responses, patients will be stratified into one of three risk groups: low, medium or high-risk. Patients in the medium- and high-risk groups will be referred to physical therapy for a matched physical therapy (PT) intervention based on the risk strata. Patients in the low-risk group will be managed in Family Medicine with an intervention that includes advice, reassurance, patient education, and NSAIDs (with no referral for imaging or specialist care).	Other: Matched Physical Therapy Intervention; Patients who are medium-risk will receive up to 6-8 physical therapy (PT) visits over a 3 month period that is guided by published evidence based practice guidelines. The PT treatment will be tailored to the physical findings and specific patient needs, and appropriate exercises, spinal mobilization/manipulation, strengthening/stretching as well as a home program will be given to improve patient pain and function and reduce disability. Patients who are high-risk will receive the evidence based PT treatment as deemed necessary. In addition, the PT treatment will incorporate principles of psychologically informed practice to address psychosocial barriers (e.g., fear avoidance, anxiety, etc) that may be impeding disability reduction. This may include instruction on chronic pain rehabilitation techniques such as the use of: pacing in order to maintain or increase activity; graded activity principles in order to increase function; and pain education and understanding responses to pain.
Active Comparator: Current Care; In three "Comparator Sites" from Family Medicine, providers will give the current care at The University of Vermont Medical Center for patients with acute and chronic low back pain.	Other: Current Care in Family Medicine; Patient education, medication management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Low Back Pain Disability Questionnaire	Low back pain disability measure	6 months

Collaborators and Investigators

• Sponsor: University of Vermont Medical Center
• Investigators: Principal Investigator: Sharon M Henry, PT, PhD, The University of Vermont Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2017
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: February 23, 2017
• First Submitted That Met QC Criteria: February 27, 2017
• First Posted (Actual): February 28, 2017

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: stratified care; psychologically informed practice; matched care
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 16-494

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No