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

NCT04494490 | Active Not Recruiting DMC

• 1 other identifier: NMCSD.2018.0034
• Study Type: interventional
• Target: 4,039
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Healthcare Utilization

  One year

• Healthcare Utilization

  One year

• Analgesic Medication Use

  One year

• Analgesic Medication Use

  One year

Study Arms (2)

Usual Care Condition

NO INTERVENTION

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.

CPG+PIPT Condition

ACTIVE COMPARATOR

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

Interventions

Clinical Practice Guidelines and Psychologically Informed Physical Therapy training/audit/feedback BEHAVIORAL

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.

CPG+PIPT Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Site Principal Investigator

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 31, 2020
• Study Start: May 1, 2021
• Primary Completion: September 30, 2023
• Study Completion (Estimated): May 14, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)