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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Behavioral: Clinical Practice Guidelines and Psychologically Informed Physical Therapy training/audit/feedback

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 Type: Interventional
• Enrollment (Actual): 4039
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shawn Farrokhi, PT, PhD; Phone Number: 619-532-8582; Email: shawn.farrokhi.civ@health.mil
• Study Contact Backup: Name: Sara Gorczynski, PT, DPT; Phone Number: 619-532-9704; Email: sara.r.gorczynski.ctr@health.mil

Study Locations

• United States
  • California
    • San Diego, California, United States, 92134
      • Naval Medical Center San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care Condition; During the usual care condition the therapists will be instructed "to act as usual," that is, to read the guidelines on low back pain if they have read previous published guidelines and not read these guidelines if they have not read any other guidelines.
Active Comparator: CPG+PIPT Condition; 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	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare Utilization	Change in frequency 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).	One year
Healthcare Utilization	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).	One year
Analgesic Medication Use	Change in frequency 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).	One year
Analgesic Medication Use	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).	One year

Collaborators and Investigators

• Sponsor: United States Naval Medical Center, San Diego
• Collaborators: University of Pittsburgh; Walter Reed National Military Medical Center; VA New York Harbor Healthcare System; Naval Health Research Center; James A. Haley Veterans Administration Hospital; Marine Corps Base Camp Pendleton

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): September 30, 2023
• Study Completion (Estimated): May 14, 2025

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): July 31, 2020

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: NMCSD.2018.0034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No