CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,817 enrolled
Drug / intervention
Pain modulation with physical pain treatment +5 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04411420
NCT04411420N/ACompleted

Improving Veteran Access to Integrated Management of Back Pain: A Pragmatic, Cluster Randomized Trial

Duke University·interventional·Posted Jun 2, 2020·Updated Jun 27, 2025

In Brief

A clinical study evaluating Pain modulation with physical pain treatment, Telephone delivered self-management counseling for increasing physical activity, and 4 other interventions for Low Back Pain and Veterans Family. Completed, enrolled 1,817 participants across 1 site.

Detailed Summary

The purpose and objective of this pragmatic trial is to examine the effectiveness of two different quality improvement care pathways for low back pain (LBP); a sequenced, integrated care pathway (ICP) and 2) a coordinated, care management pathway (CCP). We will test the central hypothesis that the ICP will reduce pain interference with normal activities and improve physical function, as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Short Form scores when compared to the CCP.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJun 2, 2020
Enrollment StartMar 8, 2021
Primary CompletionMay 13, 2024
Study CompletionJan 15, 2025
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 6.1 years ago

Interventions

Pain modulation with physical pain treatmentbehavioral

Examples of pain modulation with physical pain treatment include spinal manipulation, massage, or transcutaneous electrical nerve stimulation

Telephone delivered self-management counseling for increasing physical activitybehavioral

Centrally located physical therapy assistants will provide six weeks of telehealth consults to increase physical activity for the patient

Telephone delivered behavioral treatment for participants with high risk for continued disabilitybehavioral

Patients with a higher risk of developing chronic or persistent back pain will be identified using the nine question risk stratification start back screening tool (SBST) and will receive six additional weeks of physical activity instructions and additional pain modulation treatments as needed.

Patient preference treatment protocolbehavioral

the pain navigator will work through a shared decision making process with the patient to determine the preferred treatment protocol

Nonpharmacological guideline adherent treatment protocolbehavioral

the pain navigator will select only nonpharmacological guideline adherent treatment options for the patient

Facilitated referrals to existing VA or non-VA pain management resourcesbehavioral

the pain navigator will work with the referring physician to select only existing VA or non-VA pain management resources for the patient.