NCT04494490

Resolving the Burden of Low Back Pain in Military Service Members and Veterans: A Pragmatic Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,039 (actual)
• Sponsor: Sara Gorczynski · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The RESOLVE trial will provide a pragmatic approach to evaluate whether Physical Therapy Clinical Practice Guideline adherence can reduce pain, disability and downstream healthcare utilization for low back pain within the Departments of Defense and Veterans Affairs healthcare systems.

Detailed description

Physical therapy (PT) is frequently used for the management of low back pain (LBP) within the U.S. Departments of Defense (DoD) and Veterans Affairs (VA). However, variations in PT practice patterns and utilization of ineffective interventions lower the quality and increase the cost of care. Although, adherence to the clinical practice guidelines (CPGs) can improve outcomes and cost effectiveness of LBP care, PT CPG adherence rates remain below 50%. The RESOLVE trial will evaluate the effectiveness of an active PT CPG implementation strategy using an education/audit/feedback model for reducing pain, disability, medication use and cost of LBP care within the DoD and VA healthcare systems. The RESOLVE trial will include 3300 to 7260 patients with LBP from five DoD and VA medical facilities, using a stepped-wedge study design. An education/audit/feedback model will be used to encourage the physical therapists to better adhere to the PT CPG recommendations. The primary outcomes of disability and pain intensity will be measured with the Oswestry Disability Index and the Defense and Veterans Pain Rating Scale. Secondary outcomes will include the LBP-related medical resource utilization and biopsychosocial predictors of PT outcomes. Statistical analyses will be based on intention to treat principles and will use linear mixed models to compare treatment conditions, and examine the interactions between treatment and sub-grouping status. The RESOLVE trial will provide a pragmatic approach to evaluate whether PT CPG adherence can reduce pain, disability and downstream healthcare utilization for LBP within the DoD and VA healthcare systems.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
BEHAVIORAL	Clinical Practice Guidelines and Psychologically Informed Physical Therapy training/audit/feedback	The aim of the active training strategy is to improve the knowledge and skills of physical therapists with regard to evidence-based physical therapy with an emphasis on active treatments and PIPT for the treatment of patients with low back pain and to encourage increased adherence with CPGs. This Continuing Education (CE) training session will be offered to all therapists regardless of study participation. During the CE training session, focus will be placed on interventions that have been shown to be effective, such as interactive education and discussion, feedback, and reminders.

Timeline

• Start date: 2021-05-01
• Primary completion: 2023-09-30
• Completion: 2026-05-14
• First posted: 2020-07-31
• Last updated: 2026-01-28

Locations

1 site across 1 country: United States