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

Not Applicable

Active, not recruiting

• Conditions: Low Back Pain
• Interventions: Behavioral: Clinical Practice Guidelines and Psychologically Informed Physical Therapy training/audit/feedback

• Registration Number: NCT04494490
• Lead Sponsor: Emma Beisheim-Ryan

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.

Study Timeline

• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-31
• Study Start: 2021-05-01
• Primary Completion: 2023-09-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-28
• Study Completion: 2025-05-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 4039

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CPG+PIPT Condition	Clinical Practice Guidelines and Psychologically Informed Physical Therapy training/audit/feedback	An active Clinical Practice Guidelines (CPG) implementation strategy will be utilized with an education component in Psychologically Informed Physical Therapy (PIPT) with peer opinion leaders and a monthly audit/feedback on CPG adherence rates and patient outcomes

Primary Outcome Measures

Name	Time	Method
Disability	Every two weeks over course of PT treatment, up to 12 weeks	Change in Oswestry Disability Index (ODI)
Pain Intensity	Every two weeks over course of PT treatment, up to 12 weeks	Change in Defense and Veterans Pain Rating Scale (DVPRS) score

Secondary Outcome Measures

Name	Time	Method
Healthcare Utilization	One year	Change in extent of healthcare utilization:The medical resources of interest for this trial will include: 1) referrals to specialists (e.g., orthopedists, spine surgeons, physiatrists) and other health care providers, and 2) tests (e.g., x-rays, MRIs), surgical procedures (e.g., epidural steroid injections, laminectomy).
Analgesic Medication Use	One year	Change in extent of analgesic medication use: prescribing patterns for key drug classes commonly used for low back pain management such as non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen (Tylenol), opioid analgesics, skeletal muscle relaxants, antidepressants (e.g., tricyclic antidepressants and duloxetine), and drugs for neuropathic pain (e.g., gabapentin).

Trial Locations

Locations (1)

Naval Medical Center San Diego; 🇺🇸 San Diego, California, United States