NCT04411420

Improving Veteran Access to Integrated Management of Back Pain

Improving Veteran Access to Integrated Management of Back Pain: A Pragmatic, Cluster Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,817 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-03-08
• Primary completion: 2024-05-13
• Completion: 2025-01-15
• First posted: 2020-06-02
• Last updated: 2025-06-27
• Results posted: 2025-06-27

Locations

1 site across 1 country: United States