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

NCT03065894 | Terminated

• 1 other identifier: 16-494
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

stratified care; psychologically informed practice; matched care

Outcome Measures

Primary Outcomes (1)

• Modified Low Back Pain Disability Questionnaire

  Low back pain disability measure

  6 months

Study Arms (2)

Stratified Care

EXPERIMENTAL

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

Current Care

ACTIVE COMPARATOR

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

Interventions

Matched Physical Therapy Intervention OTHER

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.

Stratified Care

Current Care in Family Medicine OTHER

Patient education, medication management

Current Care

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosis of acute, chronic or non-specific LBP,
• between 21 - 60 years of age,
• able to stand and walk without assistance,
• able to understand and read English,
• able to understand and sign a consent form.

You may not qualify if:

• active serious spinal complications such as tumor or infection,
• active treatment for metastatic or bone cancer of the spine,
• pregnancy or less than 6 months post-partum or less than 6 months post weaning.

Sponsors & Collaborators

• University of Vermont Medical Center: lead

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sharon M Henry, PT, PhD

  The University of Vermont Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Therapy Research Educator

Model Details: Prospective, longitudinal, pragmatic, non-randomized clustered, non-blinded, controlled trial

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: February 28, 2017
• Study Start: March 29, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)