Improving Veteran Access to Integrated Management of Back Pain

Summary

The purpose and objective of this pragmatic trial is to examine the effectiveness of two different quality improvement care pathways for low back pain (LBP); a sequenced, integrated care pathway (ICP) and 2) a coordinated, care management pathway (CCP). We will test the central hypothesis that the ICP will reduce pain interference with normal activities and improve physical function, as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Short Form scores when compared to the CCP.

Conditions

• Low Back Pain
• Veterans Family

Interventions

BEHAVIORAL

Pain modulation with physical pain treatment

Examples of pain modulation with physical pain treatment include spinal manipulation, massage, or transcutaneous electrical nerve stimulation

BEHAVIORAL

Telephone delivered self-management counseling for increasing physical activity

Centrally located physical therapy assistants will provide six weeks of telehealth consults to increase physical activity for the patient

BEHAVIORAL

Telephone delivered behavioral treatment for participants with high risk for continued disability

Patients with a higher risk of developing chronic or persistent back pain will be identified using the nine question risk stratification start back screening tool (SBST) and will receive six additional weeks of physical activity instructions and additional pain modulation treatments as needed.

BEHAVIORAL

Patient preference treatment protocol

the pain navigator will work through a shared decision making process with the patient to determine the preferred treatment protocol

BEHAVIORAL

Nonpharmacological guideline adherent treatment protocol

the pain navigator will select only nonpharmacological guideline adherent treatment options for the patient

BEHAVIORAL

Facilitated referrals to existing VA or non-VA pain management resources

the pain navigator will work with the referring physician to select only existing VA or non-VA pain management resources for the patient.

Sponsors & Collaborators

• Durham VA Medical Center

  collaborator FED

• University of North Carolina, Chapel Hill

  collaborator OTHER

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• Duke University

  lead OTHER

Principal Investigators

• Susan N Hastings, MD · Duke University / Durham VA

• Steven Z George, PT, PhD · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-08

Primary Completion

2024-05-13

Completion

2025-01-15

Countries

• United States

Study Locations