Clinical trial NCT04494490: Resolving the Burden of Low Back Pain in Military Service Members and Veterans: A Pragmatic Clinical Trial
Official title: Resolving the Burden of Low Back Pain in Military Service Members and Veterans: A Pragmatic Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
Collaborators: name: United States Naval Medical Center, San Diego
name: Walter Reed National Military Medical Center
name: University of Pittsburgh
name: Naval Health Research Center
name: James A. Haley Veterans Administration Hospital
name: VA New York Harbor Healthcare System
name: Marine Corps Base Camp Pendleton
First posted: 2020-07-31
Enrollment: 4039
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Receiving physical therapy care for low back pain in an outpatient physical therapy setting

Primary outcomes:
measure: Pain Intensity
timeFrame: Every two weeks over course of PT treatment, up to 12 weeks
measure: Disability
timeFrame: Every two weeks over course of PT treatment, up to 12 weeks
Secondary outcomes:
measure: Healthcare Utilization
timeFrame: One year
measure: Healthcare Utilization
timeFrame: One year
measure: Analgesic Medication Use
timeFrame: One year
measure: Analgesic Medication Use
timeFrame: One year
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
Study officials:
References: